Hrev_master Healthcare in Low-resource Settings 2024; volume 12(s2):12751 Evaluation of the therapeutic potential and safety of Al Hayat black cumin seed oil: an observational study Bekzhan Turabekov Medical Educational Platform LLC “MedLit”, Bishkek, Kyrgyzstan Abstract The purpose of this study was to investigate the therapeutic potential and safety of the use of Al Hayat black cumin seed oil. Descriptive and discrete statistical methods and frequency analysis were applied. There were 20 participants in total aged between 11 and 67 years, both men and women. The participants were divided into three subgroups, each receiving different doses of black cumin oil: 10 mg/kg, 20 mg/kg, and 30 mg/kg, respectively. Such param- eters as general blood count, liver enzyme activities (aspartate aminotransferase and alanine aminotransferase), creatinine, and serum iron levels were analysed. A dose of 10 mg/kg was found to have no significant therapeutic or adverse effect. A dosage of 20 mg/kg demonstrated positive effects on platelet, immune cell, and creatinine values with no significant side effects. A dose of 30 mg/kg is not recommended for use due to the high risk of adverse reactions. The author also found no significant differences in the therapeutic effects and adverse reactions to black cumin oil that could be related to the gender or age of the participants. Introduction In modern medicine, the prospects for the use of plant-based remedies are greatly enhanced by public interest and the efforts of scientists. This interest is fuelled by the desire for more natural, organic ways to treat and prevent disease, as well as scientific dis- coveries that increasingly confirm the efficacy of plant extracts and compounds. Specifically, black cumin seed oil, extracted from the Nigella Sativa plant, is a prime example of a substance with a long history of use in traditional medicine due to its many poten- tial therapeutic properties. Black cumin, used as a natural remedy in different cultures, has attracted the attention of scientists in the fields of biomedicine and pharmacology.1 Despite promising anecdotal evidence and some preliminary studies suggesting a wide range of beneficial properties, from anti-inflammatory to antioxidant, rigorous scientific evaluation of black cumin oil’s effects on concrete health parameters is still in its infancy. Scientific studies to investigate its effects may provide valuable information on its mechanisms of action, efficacy, and safety of use. Thus, despite its widespread use in traditional medicine and potential benefits, black cumin oil requires further research in the context of modern medicine. Investigating the role of medicinal plants in controlling vari- ous diseases, including coronavirus infection, Ojah et al.2 focused on ethnopharmacological approach, which can offer promising strategies for the development of new medicines. This approach emphasises traditional healing methods used across cultures and explores their potential for modern medicine. However, plants such as black cumin stay outside the main focus of such studies, which makes its investigation in this context particularly relevant. Regarding this issue, Khadka et al.3 highlighted that in some coun- tries during the COVID-19 pandemic, herbal medicine gained considerable popularity, especially in the context of disease pre- vention. The authors noted that many respondents recommended the use of medicinal plants for COVID-19 prevention, although qualitative studies on the efficacy of this approach are still lack- ing. In their work, Riaz et al.,4 without focusing on black cumin, emphasised the significance of investigating phytometabolites for the development of new medicines. The scientists noted that phy- tobioactive compounds have potential in treating various diseases, making them promising candidates for clinical trials. Guo et al.5 highlighted the high therapeutic potential of nanocrystals based on medicinal plants, especially in the context of improving the phar- macokinetics of active substances. This is crucial to improve the efficacy of pharmacotherapy and overcome the serious problems associated with the low solubility and bioavailability of a range of phytopreparations, including those that may include black cumin. In the context of phytopreparation studies, Choudhury et al.6 emphasise the significance of careful control and monitoring of such products. This is to ensure their safety and efficacy, consid- ering potential risks and side effects. Controls should include stan- dardisation of ingredients, screening for toxins and other poten- tially harmful components, and clinical studies to confirm claimed Correspondence: Bekzhan Turabekov, Medical Educational Platform LLC “MedLit”, 720049, 27/3 Aaly Tokombaev Str., Bishkek, Kyrgyzstan. E-mail: turabekovbek@outlook.com Key words: pharmacognosy, phytotherapy, immunomodulation, integra- tive medicine, thymoquinone. Conflict of interest: the author declares no potential conflict of interest. Funding: not applicable. Ethics approval: the study was approved by the Ethics Commission of the Medical Educational Platform LLC “MedLit”, No. 12455. Patients’ consent for publication: informed consent was obtained from all individuals included in this study. Availability of data and material: the data supporting the findings of this study are available on request from the corresponding author Received: 25 June 2024. Accepted: 11 September 2024. Early view: 9 October 2024. This work is licensed under a Creative Commons Attribution 4.0 License (by-nc 4.0). ©Copyright: the Author(s), 2024 Licensee PAGEPress, Italy Healthcare in Low-resource Settings 2024; 12(s2):12751 doi:10.4081/hls.2024.12751 Publisher's note: all claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organi- zations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher. [Healthcare in Low-resource Settings 2024;12(s2):12751] [page 83] Non -co mmerc ial us e o nly properties. This approach ensures that patients get the maximum benefit from phytopreparations without compromising their health. Thus, the purpose of this study was to collect and analyse empirical data to understand the effect of black cumin oil con- sumption on human body at different dosages. The main objectives of the research are the following: i) to figure out the ideal dosage to enhance effectiveness while limiting negative effects; ii) to assess whether factors such as age and gender influenced the ther- apeutic response to black cumin oil. Materials and Methods The statistical data were obtained by analysing medical records, including patients’ medical histories, as well as the results of laboratory testing methods, including general blood counts, analysis of liver enzyme activities such as Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT), creatinine, and serum iron levels. These indicators were chosen as the main criteria for assessing the effects of the medicine on the participants’ bodies. There were 20 participants in total who were selected accord- ing to predetermined inclusion and exclusion criteria. Participants were informed about the purpose and methods of the research and provided their informed consent to participate. Of the 20 partici- pants initially selected, 18 participants reached the end of the study. Two participants discontinued their participation for person- al reasons. Only the results of those participants who fully com- pleted the study were used for data analysis. Participants’ ages ranged from 11 to 67 years (mean age: 35.33 years, mode: 36 years, median: 34.5 years). Both males and females took part in the examination, the data regarding the sampling frame by gender is presented in Figure 1. To structure the sample, optimise the results, and to better understand the health effects of black cumin oil, the author divided the participants into three subgroups. Each of these subgroups received a different specific dose of black cumin oil, namely 10 mg/kg, 20 mg/kg, and 30 mg/kg respectively. The structure of the study group according to the medication dosage used is presented in Figure 2. This separation allowed for a differentiated analysis of the effects of different doses of black cumin oil on the body, which enabled a more accurate determination of its efficacy and safety. The dosage was allocated based on perceptions of safe and potentially effective levels of black cumin oil consumption.7,8 The main objective of this approach was to determine the best dosage that would maximise efficacy while minimising the risk of side effects. Each group of participants took a corresponding dosage of black cumin oil for 15 days, during which time their health status was monitored regularly. Using normal venepuncture techniques, participants’ blood samples were drawn into vacuum tubes containing ethylenedi- aminetetraacetic acid (EDTA)for a complete blood count and serum separator tubes for biochemical analysis. To guarantee ade- quate mixing, samples were gently flipped eight to ten times as soon as they were collected. To preserve cellular integrity, EDTA tubes for haematology were examined four hours after collection and kept at room temperature (20-25°C). In order to separate the serum, serum separator tubes were centrifuged at 3000g for 10 minutes after being left to clot at room temperature for 30 minutes. To maintain the stability of the analytes, the serum was aliquoted into cryovials and kept at -80°C until analysis, which was carried out 30 days after collection. Every sample had a unique label applied to it, and regular safety procedures were followed when handling it. All storage units had temperature logs kept in order to guarantee constant conditions. Excluded from analysis were sam- ples exhibiting haemolysis or lipemia, in order to avoid influencing test outcomes. All of the laboratory equipment underwent stringent calibra- tion and quality control procedures to guarantee the dependability and accuracy of experimental results. Automated biochemistry and haematology analysers were validated with multi-level control materials and daily calibrated using calibrators supplied by the manufacturer. The Clinical Laboratory Improvement Amendments (CLIA) recommendations were followed in setting the acceptance criteria and creating calibration curves for each analyte. Every piece of equipment had a maintenance journal that recorded both routine maintenance and any necessary corrective action. Any equipment that did not meet performance standards was taken out of service right away and left to be fixed or recalibrated. Social and political factors affecting public health Figure 1. Structure of the study group by gender. Source: com- piled by the author. Figure 2. Structure of the study group according to the medication dosage used. Source: compiled by the author. [page 84] [Healthcare in Low-resource Settings 2024;12(s2):12751] Non -co mmerc ial us e o nly The investigation predominantly used descriptive and discrete statistical methods and cluster analysis. Descriptive statistics were used to provide an overview of the data, including mean values, standard deviations, and ranges for key variables such as blood counts and liver enzyme activities. This provided a basic under- standing of the distribution and underlying trends in the data. Discrete statistics were used to determine statistically significant differences between groups of participants receiving different dosages of black cumin oil. This method helped to assess whether different dosage of the medication affected the health indicators under study to a statistically significant degree. Cluster analysis was used to identify groups of participants with analogous treat- ment response patterns. This provided a greater understanding of individual differences in treatment response and helped to identify potential subgroups of participants who respond best to certain dosages. Results Within the sample provided, it was important to observe how even a minimal dose of black cumin oil could affect various bio- chemical and physiological parameters such as blood counts and liver enzyme activities. This dose, 10 mg/kg, was chosen as the starting point of the research based on the assumption of its safety and potential efficacy. It was assumed that such a dose could pro- vide the minimum therapeutic effect while reducing the risk of undesirable adverse reactions. The results of monitoring of the studied indicators, both preliminary and at the end of the study, are presented in Table 1. When analysing these results, it was recorded that the effect of the medication was moderated. Minimal changes in clinical parameters indicate insignificant effect of this dosage on the biochemical profile of the organism. This can be interpreted as a lack of overt therapeutic activity or as achieving only a marginal effect that is on the edge of statistical significance. A comparable pattern was observed in the context of side effects, with very few or no side effects. These results may indicate a high safety profile of the medication at the indicated dosage, which, at the same time, does not make it potentially suitable for long-term use or as a com- ponent of complex therapy, due to the lack of clinically significant results. However, the absence of significant side effects and mini- mal therapeutic effect may also indicate that the dose is insufficient to achieve the desired therapeutic effect. It is possible that such a dosage cannot activate the mechanisms responsible for the phar- macological action of the medication, and therefore cannot fully reveal the potential of the active components of black cumin oil. These analyses of the laboratory results of this subgroup provided the basis for further investigation of higher doses to determine the threshold at which a significant therapeutic effect comparable to an appropriate level of safety is observed. The study of minimal effects and adverse reactions is also important for the development of a complete medication profile. This is particularly relevant when developing dosages for clinical use that consider individual patient characteristics and the possibility of an individualised treat- ment approach. Considering that the previous dosage demonstrat- ed only minimal effects on participants’ biochemical parameters and no significant side effects, the second subgroup provided a bet- ter opportunity to investigate whether the increased dosage would result in more noticeable health effects. The corresponding results are presented in Tables 2 and 3. It was found that increasing the dosage of black cumin oil to 20 mg/kg resulted in markedly posi- tive changes in the clinical parameters of the participants. The most significant trend was the normalisation of platelet levels, which may indicate improved blood coagulation and reduced risk of haemorrhagic complications. Furthermore, mobili- sation of immune cells was observed, which is reflected in the white blood cell count in the blood, suggesting an increase in the body’s immune response. Another indicator that underwent changes as a result of the increased dosage was creatinine levels, which also normalised, which may indicate a positive effect on renal function. Interestingly, in one case studied, the use of black cumin oil at this dosage optimised the significantly elevated liver enzymes ALT and AST, which may be related to both individual patient characteristics and the general pharmacological properties of the medication. Importantly, increasing the dose to 20 mg/kg was not accompanied by the occurrence of side effects. This fact suggests that this dosage is not only safe, but also probably optimal in terms of efficacy/safety ratio. Complementing the information presented above, attention should also be given to considering the therapeutic efficacy of a 30 mg/kg dose of black cumin oil. Considering the positive effects of the previous dose of 20 mg/kg on platelet counts, immune activity and creatinine levels, there was Social and political factors affecting public health Table 1. Mean values of laboratory results in patients from the subgroup treated with the medication at a dosage of 10 mg/kg. Blood parameter Preliminary results* Results after 15 days of use* Liver enzymes, creatinine, and serum iron values Creatinine, μmol/l 52 54.2 ALT, IU/l 12.6 13 AST, IU/l 16.5 14.4 Iron level, µmol/l 10.9 13.6 General clinical parameters Haemoglobin, g/l 108 118 Erythrocytes (×1012/l) 4.2 4.3 Haematocrit, % 37.2 37.4 Mean corpuscular volume (MCV), fl 88.5 90.2 Mean corpuscular haemoglobin concentration (MCHC), g/dl 320 328 White blood cells (×109/l) 6.1 6.2 Neutrophils (×109/l) 4.2 4.1 Lymphocytes (×109/l) 1.3 1.5 Platelets (×109/l) 223 230 Note: IU/l – international units per litter; *p>0.05. Source: compiled by the author. [Healthcare in Low-resource Settings 2024;12(s2):12751] [page 85] Non -co mmerc ial us e o nly a legitimate interest in whether further dose increases could result in enhanced therapeutic effects or side effects. This phase of the research evaluated the efficacy and safety of black cumin oil when administered at higher doses, which is critical to determining its maximum tolerated dosage. When the results of laboratory meth- ods were analysed on participants who used the medication at a dosage of 30 mg/kg, it was found that this dose did not lead to the expected improvement in therapeutic outcomes. Specifically, there was no further improvement in blood parameters, which could indicate a more pronounced beneficial effect on physiological body functions, compared to the group receiving 20 mg/kg. A significant and worrying consequence of the increased dosage was the occurrence of pronounced side effects. Complaints of decreased sleep quality, decreased general well-being of partic- ipants, and non-specific gastrointestinal disorders such as discom- fort, bloating, and stool disturbances were observed. These symp- toms may indicate that this dosage exceeds physiologically accept- able intake rates for vegetable oils, resulting in undesirable body reactions.9,10 These side effects are probably not directly related to the pharmacological properties of black cumin, but rather result from the specific effects of plant-based oils in general when con- sumed in excess. Such reactions may be caused by both the general properties of fatty acids and the presence of certain components (such as thymoquinone, alkaloids like nigellicine, and saponins), which in large quantities may interfere with the normal functioning of the digestive system and affect metabolism.11-13 Thus, although the previous dosage of 20 mg/kg showed potential optimality, a further dose increase to 30 mg/kg did not improve the therapeutic results but provoked adverse reactions. This emphasises the need for careful dose balancing to maximise benefits while minimising risks. The study also analysed possible factors that could influence the therapeutic efficacy of the medication. Specifically, attention was paid to participant characteristics such as gender and age. Analyses of the data collected, which included a wide range of age groups and representation of both sexes, revealed no significant differences in response to therapy that could be attributed to the sex or age of the patients. Analysis of the available data made it possible to verify that the therapeutic effect of black cumin oil appears to be stable and homogeneous among the entire sample, with no apparent dependence on the parameters mentioned. In Social and political factors affecting public health Table 3. Mean values of laboratory results in patients from the subgroup receiving the medication at a dosage of 30 mg/kg. Blood parameter Preliminary results* Results after 15 days of use* Liver enzymes, creatinine, and serum iron values Creatinine, μmol/l 44 43 ALT, IU/l 6.3 9.7 AST, IU/l 9.2 8.2 Iron level, µmol/l 9.6 12.8 General clinical parameters Haemoglobin, g/l 112 121 Erythrocytes (×1012/l) 3.82 4.26 Haematocrit, % 36.4 37.6 MCV, fl 79 83 MCHC, g/dl 322 334 White blood cells (×109/l) 5.1 4.8 Neutrophils (×109/l) 3.5 3.4 Lymphocytes (×109/l) 2.1 2.7 Platelets (×109/l) 312 336 Note: *p>0.05. Source: compiled by the author. [page 86] [Healthcare in Low-resource Settings 2024;12(s2):12751] Table 2. Mean values of laboratory results in patients from the subgroup receiving the medication at a dosage of 20 mg/kg. Blood parameter Preliminary results* Results after 15 days of use* Liver enzymes, creatinine, and serum iron values Creatinine, μmol/l 48 40.4 ALT, IU/l 28.2 16 AST, IU/l 40.1 14.2 Iron level, µmol/l 13.2 16.3 General clinical parameters Haemoglobin, g/l 123 133 Erythrocytes (×1012/l) 4.32 4.46 Haematocrit, % 38.6 39 MCV, fl 86.4 89.2 MCHC, g/dl 334 362 White blood cells (×109/l) 6.3 5.8 Segmented neutrophils (×109/l) 3.9 3.6 Lymphocytes (×109/l) 1.42 1.64 Platelets (×109/l) 276 296 Note: *p>0.05. Source: compiled by the author. Non -co mmerc ial us e o nly none of the subgroups analysed were gender or age differences observed to make adjustments to the clinically significant response to the medication. The lack of variability in the efficacy of the medication according to gender and age may indicate its wide potential range of use and provides a basis for a better understand- ing of its mechanisms of action. This may also indicate that the medication has versatile properties that make it suitable for a diverse patient population, which is particularly significant in the context of personalised medicine. The author decided to include several pregnant and breastfeed- ing women in the sample, which represents a prominent aspect in assessing the safety and efficacy of the medication in these special patient groups. Despite the potential risks associated with the use of any medication during pregnancy and lactation, no features or undesirable effects specific to these groups were identified. However, the use of black cumin oil or any other preparations in pregnant and lactating women requires extra caution.14-16 Pregnancy and lactation period are accompanied by a range of physiological changes in a woman’s body, which may affect the metabolism of medications and their pharmacokinetics.17,18 Furthermore, it is vital to consider the potential risk to the devel- oping foetus or infant, as some substances may penetrate the pla- cental barrier or be excreted with breast milk.1 Therefore, even though there were no adverse effects identified in this investiga- tion, it is critical that care be taken when prescribing dosages and monitoring the health of pregnant and breastfeeding women taking black cumin oil. This requires an individualised approach and care- ful assessment of the balance of potential benefits and risks for each woman and her baby. It is recommended that such decisions be made in conjunction with a qualified medical professional, based on a complete clinical picture and considering all the indi- vidual characteristics of the pregnant or breastfeeding woman. In the context of the findings, it is also necessary to mention some of the challenges and limitations that accompanied the exe- cution of the study. Although the it has provided valuable prelimi- nary data, it has a range of specific limitations that affect the inter- pretation and generalisation of its findings. Firstly, this is an obser- vational study conducted by a single researcher. This approach can introduce subjectivity into the process of data collection and anal- ysis, as well as in the interpretation of the findings. Lack of inde- pendent observation and validation can lead to possible misleading conclusions, making the results less valid and reliable. The second significant limitation is the sample size. Using a small number of participants reduces the statistical significance of the research, which may limit the ability to detect real effects or differences. Moreover, there was no control group or randomised allocation of participants, which is a key element in establishing causality. The absence of a control group means that it is not possible to deter- mine with certainty whether the observed changes were the result of the medication or caused by other factors. Randomisation helps to eliminate systematic errors and bias, providing more reliable and objective results. Considering these limitations, the findings of the current study should be regarded as preliminary and interpreted with caution. Additional studies, including larger controlled clini- cal trials, are needed to provide a more accurate and generalised picture, which may confirm or refute the initial observations and conclusions. Discussion In the context of the current research, it is crucial to make a comparative analysis with contemporary studies conducted by for- eign authors. Such a comparison will not only enrich the under- standing of the topic at hand, but will also identify potential gaps in knowledge, as well as identify areas for future studies. Comparison with international studies provides an opportunity to establish the extent to which the findings of the current investiga- tion are consistent with global scientific evidence. This will also help to assess the universality and applicability of the findings on a larger scale. International studies may reveal various aspects of black cumin oil use, including its pharmacological properties, mechanisms of action, potential therapeutic applications and pos- sible side effects, which may not have been fully covered in the current work. Thus, A. Zarrouk et al.19 addressed the question of the compo- sition of black cumin and its oil. In their paper, the researchers sug- gested that black cumin and its derivatives, including black cumin oil, have a wide range of beneficial properties, making them promising for the development of medicines to combat various dis- eases. The scholars focused on the rich composition of black cumin seeds, which includes proteins, fats, carbohydrates, fibre, and inorganic mineral compounds. They also considered the com- position of black cumin oil, which contains both saturated and unsaturated fatty acids, including linoleic, oleic, dihomolinoleic, and eicodadiene acids. Furthermore, the oil contains alkaloids (nigellicins and nigelladine), saponins, tocopherols, phytosterols, flavonoids, and essential oil, as well as quinone components, including thymoquinone.20 These components account for the wide range of therapeutic properties of black cumin oil, making it poten- tially useful in the treatment of a variety of diseases. Despite the avoidance of detailed analyses of individual clinical cases, the results of the cited work effectively complement the present study in terms of researching the components of the investigated sub- stance and, consequently, the mechanisms of their effects on the human body. A. Hannan et al.21 also considered possible mechanisms of the effect of black cumin oil on the human body. The researchers noted that black cumin and its key component, thymoquinone, have immunomodulatory properties. Ethanolic extract of black cumin was also found to increase the population of macrophages and stimulate the phagocytic activity of their three types. The antioxi- dant properties of black cumin also contribute significantly to its therapeutic effects. Black cumin is a potential source of natural antioxidants, lowering levels of reactive oxygen species and increasing the activity of antioxidant enzymes such as superoxide dismutase and catalase, as well as molecules such as glutathione.22 The researchers found a considerable increase in total antioxidant activity in the blood and a decrease in malonic dialdehyde levels on the background of black cumin seed supplementation. In addi- tion, black cumin and thymoquinone have anti-inflammatory prop- erties. Thus, freshly extracted black cumin oil reduced interleukin- 6 levels in human preadipocytes, whereas oil stored for some time reduced interleukin-1beta levels. Consequently, although the paper does not cover aspects of the effects of the substance on some functions, specifically the liver, it greatly enriches the understand- ing of the pathogenetic mechanisms of the effects of the studied substance on the human body. E.M. Yimer et al.23 considered black cumin as a basis for the development of medicines for a wide range of diseases. The researchers noted that due to its wide range of properties, black cumin could serve as a substrate for medicines in the fields of neu- rology, oncology, cardiology, immunology, and other areas of medicine. Specifically, the authors highlight its potential applica- tion in the treatment of neurological disorders such as Alzheimer’s, Parkinson’s, and epilepsy, as well as cancers including breast and Social and political factors affecting public health [Healthcare in Low-resource Settings 2024;12(s2):12751] [page 87] Non -co mmerc ial us e o nly prostate cancer.24 The researchers also highlighted the antioxidant, antimicrobial, and anti-inflammatory properties of black cumin, making it a promising candidate for the development of new medicines. However, scientists have ignored the issue of side effects of the black cumin-based remedies in question. Some researchers, such as M.S.K. Ermumcu and N. Şanlıer25 considered the therapeutic potential of black cumin through the lens of, as they suggested, its most biologically active component, thymoquinone. The scholars emphasised that the use of black cumin-based preparations holds great promise in diabetes therapy. Thymoquinone and other components contribute to optimising glucose control, mainly by stimulating the metabolism of carbohy- drates and reducing their concentration in the blood.26,27 Thymoquinone along with some other components of black cumin extract stimulates insulin production, improves energy metabolism in mitochondria, and has an indirect hepatoprotective effect. It also affects the functioning of membrane receptors and improves their sensitivity to insulin. Black cumin, specifically, effectively inhibits gluconeogenesis – a key factor in the development of hypergly- caemia in diabetic patients, by reducing the activity of enzymes involved in this process.28 Black cumin extract restricts glucose absorption and blocks its transport systems. Thymoquinone also exerts a protective effect on pancreatic β-cells by preventing oxida- tive stress.29,30 Black cumin and thymoquinone have properties that promote weight loss and improve the lipid profile in diabetic patients, as evidenced by a reduction in body weight sometime after starting to take the preparations.31 Thus, this study provides valuable additions to the investigation of the effects of black cumin-based medicines in the treatment of a diabetes mellitus. J.V. Thomas et al.32 conducted a randomised double-blind placebo-controlled study with an analogous purpose. The scholars evaluated the safety of using black cumin oil at a dose of 200 mg/day for 90 days. Seventy participants were involved. Both bio- chemical and general clinical parameters were analysed, and side effects were recorded. No serious side effects or significant changes in haematological parameters were reported. There were also no significant changes in biochemical parameters related to liver function (ALT, AST) and renal function (serum creatinine and urea). However, lipid profile analysis showed a significant (P<0.05) decrease in total cholesterol, low-density lipoprotein, very low-density lipoprotein, and triglycerides. Thus, the cited study differed slightly from the results obtained in the present one: the discrepancy primarily concerns the presence of side effects and the focus of the therapeutic action of the medicine. N. Salaria et al.33 directly addressed the safety of the use of black cumin derivatives. The researchers emphasised that the con- sumption of N. sativa at a dosage of 5 ml/day for 26 days caused no significant adverse effects on hepatic, renal, or gastrointestinal functions. It was also found that patients with hepatitis C who took black cumin oil capsules experienced epigastric pain and hypogly- caemia. In isolated cases, consumption of oil and ground seeds resulted in increased levels of AST, ALT, and alkaline phosphatase. However, no significant changes in kidney or liver function were found in people with diabetes who took black cumin at doses of 1, 2, and 3 g/day for 3 months. The scholars noted that some people may experience allergic reactions when using black cumin oil, such as allergic contact dermatitis when applied topically. Such cases have been reported in patients using black cumin oil exter- nally. Thus, the paper extends previous findings to cover a wider range of medication dosages. However, researchers have neglected to investigate the mechanisms of side effects. Thus, the studies of foreign colleagues devoted to the investi- gation of the therapeutic efficacy and safety of black cumin oil were reviewed. The analysis of the obtained results helped to sup- plement and expand the ideas about the main pharmacological effects of this phytopreparation, as well as to identify some differ- ences in the nature and severity of its action. Comparison of the data obtained in the present study with the findings of foreign stud- ies is of great value for a more complete understanding of the ther- apeutic and adverse potential of black cumin oil in different condi- tions of its application. Conclusions By interpreting the findings, it is possible to conclude on the therapeutic effects and side effects of black cumin oil. At low dosages of the medicine, a restrained effect on the biochemical profile of the organism was observed, indicating that there was no apparent therapeutic activity or only a marginal effect. There were few or no side effects in this case, which may indicate a high safety profile of the medication at these dosage levels. At the dosage of 20 mg/kg, marked positive changes in clinical parameters were observed, including normalisation of platelet levels. Creatinine levels also normalised, which may indicate a positive effect on renal function. No side effects were observed at this dosage, mak- ing it potentially the best dosage in terms of efficacy/safety ratio. However, when the dose was further increased to 30 mg/kg, no fur- ther improvement in clinical parameters was recorded, but pro- nounced side effects appeared, including complaints of impaired sleep quality, decreased general well-being, and gastrointestinal disturbances. This indicates that the dosage exceeds physiological- ly acceptable intake rates for vegetable oils. According to the results, the therapeutic effects of black cumin oil appeared to be stable and homogeneous among the different groups of participants. This indicates its wide potential range of applications and versatile properties, making it suitable for a diverse patient population. Pregnant and breastfeeding women were also included in the study, which represents a prominent aspect in assessing the safety and efficacy of the medication in these special patient groups. However, despite no adverse effects identified, extra caution is required when using black cumin oil in pregnant and lactating women. Notably, clinical trials with more participants from different demographic groups are needed to increase the validity of the results. This will help to assess the effi- cacy and safety of black cumin-based products more accurately. Research vectors in this area should focus on better understanding the biochemical and molecular mechanisms underlying the thera- peutic action of black cumin, which will provide a better insight into its effects and develop more effective dosage forms. References 1. Dosoky NS, Setzer WN. Maternal reproductive toxicity of some essential oils and their constituents. Int J Mol Sci 2021;22:2380. 2. Ojah EO. Medicinal plants: Prospective drug candidates against the dreaded Coronavirus. Iberoam J Med 2020;2:314- 21. 3. Khadka D, Dhamala MK, Li F, et al. The use of medicinal plants to prevent COVID-19 in Nepal. J Ethnobiol Ethnomed 2021;17:26. 4. Riaz M, Khalid R, Afzal M, et al. Phytobioactive compounds as therapeutic agents for human diseases: A review. Food Sci Social and political factors affecting public health [page 88] [Healthcare in Low-resource Settings 2024;12(s2):12751] Non -co mmerc ial us e o nly Nutr 2023;11:2500-29. 5. Guo M, Qin S, Wang S, et al. Herbal medicine nanocrystals: A potential novel therapeutic strategy. Molecules 2023;28:6370. 6. Choudhury A, Singh PA, Bajwa N, et al. Pharmacovigilance of herbal medicines: Concerns and future prospects. J Ethnopharmacol 2023;309:116383. 7. Ramalingam K, Ittiyavirsh S, Kuttan R, et al. Safety assess- ment of a thymoquinone-rich black cumin (Nigella sativa) oil (BlaQmax®): Acute and sub-chronic toxicity studies. J Nutr Food Sci 2021;11:811. 8. Telci I, Izgi MN, Ozek T, et al. Effects of different nitrogen doses on thymoquinone and fatty acid composition in seed oil of black cumin (Nigella sativa L.). J Am Oil Chem Soc 2022;99:229-37. 9. Ghane ET, Poormohammadi A, Khazaei S, Mehri F. Concentration of potentially toxic elements in vegetable oils and health risk assessment: A systematic review and meta- analysis. Biol Trace Elem Res 2022;200:437-46. 10. Lammari N, Louaer O, Meniai AH, et al. Plant oils: From chemical composition to encapsulated form use. Int J Pharm 2021;601:120538. 11. Hosni R, Haffez H, Elkordy H. Common applications of black cumin seed (Nigella sativa) oil in folk medicine. J Adv Pharm Res 2023;7:1-14. 12. Akaberi T, Akaberi M, Farhadi F, Ahmad S. Black Cumin Seeds: From ancient medicine to current clinical trials. In: Atta-ur-Rahman, Choudhary MI, Yousuf S, eds. Science of Spices and Culinary Herbs – Latest Laboratory, Pre-clinical, and Clinical Studies. Sharjah: Bentham Science Publisher; 2021. pp 27-59. 13. Aliiev RB. Features of the endocrine activity of fat tissue in metabolism disorders. Bull Med Biol Res 2023;15:26-32. 14. Bernstein N, Akram M, Yaniv-Bachrach Z, Daniyal M. Is it safe to consume traditional medicinal plants during pregnan- cy? Phytother Res 2021;35:1908-24. 15. Kahssay SW, Tadege G, Muhammed F. Self-medication prac- tice with modern and herbal medicines and associated factors among pregnant women attending antenatal care at Mizan-Tepi University Teaching Hospital, Southwest Ethiopia. Heliyon 2022;8:e10398. 16. Shahini E, Luhovyi S, Kalynychenko H, et al. Rational use of oilseed waste to increase dairy productivity. Int J Environ Stud 2023;80:442-50. 17. Chen Y, Xu Y, Han X, et al. Azacytidine shows potential in controlling the chilling injury of banana peel during cold stor- age. Food Control 2024;159:110283. 18. Balarastaghi S, Delirrad M, Jafari A, et al. Potential benefits versus hazards of herbal therapy during pregnancy; A system- atic review of available literature. Phytother Res 2022;36:824- 41. 19. Zarrouk A, Martine L, Grégoire S, et al. Profile of fatty acids, tocopherols, phytosterols and polyphenols in Mediterranean oils (argan oils, olive oils, milk thistle seed oils and nigella seed oil) and evaluation of their antioxidant and cytoprotective activities. Curr Pharm Des 2019;25:1791-805. 20. Nikolova NS, Danyliv SI. Analysis of fatty oil Nigella sativa L. produced in Ukraine and Bulgaria. Bull Med Biol Res 2022;4:80-3. 21. Hannan A, Rahman A, Sohag AAM, et al. Black cumin (Nigella sativa L.): A comprehensive review on phytochem- istry, health benefits, molecular pharmacology, and safety. Nutrients 2021;13:1784. 22. Mukhametov A, Aliyeva N, Musayeva N, et al. Antioxidant activity and phenolic content of cereal food concentrates: Import control issues. Agric Conspec Sci 2023;88:317-24. 23. Yimer EM, Tuem KB, Karim A, et al. Nigella sativa L. (black cumin): A promising natural remedy for wide range of illness- es. Evid Based Complement Alternat Med 2019;1528635. 24. Novak-Mazepa CO, Sachuk NV, Marushchak MI. Analysis of factors associated with arterial hypertension and the quality of patients’ life. Bull Med Biol Res 2023;5:60-7. 25. Ermumcu MSK, Şanlıer N. Black cumin (Nigella sativa) and its active component of thymoquinone: Effects on health. J Food Health Sci 2017;3:170-83. 26. Chen Y, Li D, Zhang X, et al. Azacytidine-induced hypomethy- lation delays senescence and coloration in harvested strawber- ries by stimulating antioxidant enzymes and modulating abscisate metabolism to minimize anthocyanin overproduc- tion. Food Chem 2023;407:135189. 27. Kurmanova A, Urazbayeva G, Terlikbayeva A, et al. Diagnostic significance of blood lymphocyte activation mark- ers in pre-eclampsia. Clin Exp Immunol 2024;215:94-103. 28. Svyatova G, Berezina G, Danyarova L, et al. Genetic predispo- sition to gestational diabetes mellitus in the Kazakh popula- tion. Diabetes Metab Syndr 2022;16:102675. 29. Salyha N. Regulation of oxidative stress and lipid peroxidation induced by epinephrine: The corrective role of L-Glutamic acid. Int J Med Med Res 2023;9:32-8. 30. Ilderbayev O, Okassova A, Rakhyzhanova S, et al. The levels of oxidative stress in a combination of stress factors. J Med Life 2022;15:927-31. 31. Kudabayeva KI, Bazargaliev YS, Darzhanova KB, Agzamova RT. Peculiarities of chronic gastritis in diabetes mellitus type 2. Eur J Phys Health Educ 2014;6:1-5. 32. Thomas JV, Mohan ME, Prabhakaran P, et al. A phase I clinical trial to evaluate the safety of thymoquinone-rich black cumin oil (BlaQmax®) on healthy subjects: Randomized, double- blinded, placebo-controlled prospective study. Toxicol Rep 2022;9:999-1007. 33. Salaria N, Kumari I, Neeraj, et al. Concept of polycystic ovar- ian syndrome: Anti-PCOS plants in the Unani system of medicines. In: Hajam YA, Kumar R, Thakur DR, Rai S, eds. Herbal Medicine Applications for Polycystic Ovarian Syndrome. Boca Raton: CRC Press; 2023. pp 128-48. Social and political factors affecting public health [Healthcare in Low-resource Settings 2024;12(s2):12751] [page 89] Non -co mmerc ial us e o nly