International Journal of Human and Health Sciences Vol. 05 No. 01 January’21

96

Original article:
Clinical Efficacy and Safety of ‘Oxy +’ in Type 2 Diabetes: A Pilot Study

Md. Anzar Alam1, Mariyam Ahad1, MohdAleemuddin Quamri1, Fasihur Rehman Ansari1,
Farooqui Shazia Parveen1

Abstract:
Background and objectives: Diabetes is a common metabolic disorder.Type 2 diabetes 
accounts for the vast majority of around 92% of the population worldwide. Long term 
hyperglycemia leads to macro and microvascular complications. Oxy+ is a nutraceutical 
capsule which contains mainly Arthrospira (spirulina). Most of the diabetic people use it. 
Hence a clinical trial was conducted to evaluate the clinical efficacy and safety of Oxy 
+ in Type 2 Diabetes.Material Methods: The study was designed as a single-blind pilot 
study; 10 eligible patients of type 2 diabetes were allocated. Oxy+ was given in capsule 
form; 2 capsules twice daily orally for 45 days after the meal. Test drug was evaluated 
on subjective parameters at 0th, 15th, 30th and 45th days whereas objective parameters 
were assessed before and after the treatment. The results of the intervention were analyzed 
using suitable statistical methods.Results and Observation:The study effects on subjective 
parameters like polyuria, tiredness, polyphagia, polydipsia, and Tingling Sensation 
were found significantly reduced. The objective parameters were assessed before and 
after as Mean ± SD for FBS (164.4±36.019 vs 111.1±25.075), PPBS (248.5±51.70 vs 
170.1±45.148) and HbA1c (9.14±1.517 vs 6.95±1.224).The results were analyzed after 
using paired‘t’ test.Interpretation and Conclusion:The findings about both parameters 
(subjective and objective) that the ‘Oxy+’ is effective in type 2 diabetes and the cure was 
considerable. Safety parameters (SGOT, SGPT, Blood Urea, and Serum Creatinine) were 
remained unchanged. Therefore, it can be concluded that the ‘Oxy+’ would be safe and 
effective in the management of type 2 diabetes.
Keywords: Type 2 Diabetes; Oxy+; metabolic disorder; nutraceutical; Arthrospira 
(spirulina).

Correspondence to: Dr. Md AnzarAlam. Lecturer, Dept. of Moalajat, National Institute of Unani 
Medicine, Bangalore, India. E-mail:dranzarnium@gmail.com

1. Department of Moalajat, National Institute of Unani Medicine, Bangalore, India.

International Journal of Human and Health Sciences Vol. 05 No. 01 January’21 Page : 96-100
DOI: http://dx.doi.org/10.31344/ijhhs.v5i1.241

Introduction:
Diabetes mellitus is a group of metabolic diseases 
characterized by chronic hyperglycemia resulting 
from defects in insulin secretion, insulin action, or 
both.1Diabetes mellitus (DM) is probably one of the 
oldest diseases known to mankind and it was first 
reported in Egyptian manuscript about 3000 years 
ago.2Type 2 diabetes accounts for the vast majority 
around 92% of diabetes worldwide.3According to 
IDF (International Diabetes Federation) Atlas 9th 
edition 2019 worldwide prevalence of Diabetes is 
463 million and it is expected to be 700 million in 
the year of 2045.4The estimated global direct health 
expenditure on diabetes in 2019 is USD 760 billion 
and is expected to grow to a projected USD 825 
billion by 2030 and USD 845 billion by 2045.5The 
main cause is poor glycaemic control which 

leads to microvascular(Diabetic nephropathy, 
neuropathy, and retinopathy),6 and macrovascular 
(Coronary artery disease, peripheral arterial 
disease, and stroke) complications.7Diabetes 
can be controlled effectively by reducing 
overweight and by taking a balanced lifestyle 
(diet and physical activity) in combination 
with medication when needed.8,9Biguanides,11 
sulfonylureas,12 thiazolidinediones, α-glucosidase 
inhibitors, sodium-glucose co-transporter 
inhibitors,13meglitinides, incretins, DPP-4 
inhibitors and hormone analoges are commonly 
used for the treatment of this debilitating 
disease.14,15Long term use of the above-mentioned 
medications leads to a multitude of complications; 
hypoglycemia, renal issues, heart problems and 
GIT disorders.16,17



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International Journal of Human and Health Sciences Vol. 05 No. 01 January’21

Oxy+ is a natural source of oxygen found in nature 
and used as a dietary supplement and manufactured 
in Aruba for lifefactors.18It is a richest source of 
Arthrospira (spirulina) (contain phycocyanin, 
sulfated polysaccharides, γ-linoleic acid, carotene, 
iron etc.)19,20 and which have been reported to be an 
antioxidant, immuno-modulator, hypoglycemic, 
anti-dyslipidemic, hepatoprotective, antiviral and 
anticancer activities.21,22Previous pre-clinical,23 
and clinical studies have shown that Arthrospira 
(spirulina) and its active ingredients can reveal 
anti-diabetes properties.24–27 This interpretation 
led us to substantiate the hypoglycemic activity 
of Research Drug among diagnosed cases of type 
2 diabetes. Therefore, a study was contemplated 
to evaluate the clinical efficacy and safety of 
Research Drug (Oxy+) in type 2 Diabetes.
2. Materials and Methods:
2.1 Participants:
Patients were identified and recruited from 
different clinics from Bangalore and called 
to enroll OPD of National Institute of Unani 
Medicine (NIUM) Bangalore. Inclusion criteria 
included the diagnosed cases of type 2 DM with 
Fasting Blood Sugar>126 mg/dl; Postprandial 
Blood Sugar>200 mg/dl, HbA1c>6.5%, and aged 
between 30-60 years of both gender, patients 
willing to participate in the study and ready to 
follow the instructions.24,28Exclusion criteria 
included pregnant and lactating mother and other 
complications of diabetes.
2.2 Study Design:
Eligible patients with type 2 diabetes were enrolled 
to participate in this study. At first, all participants 
were informed about the study protocol by being 
given a complete description of the objectives, 
benefits and potential harm of the study. Informed 
consent was received from each participant who 
chosen to participate in the study.Total 30 subjects 
are screened, 18 are excluded, 2 are denied and 
finally10 subjects who met the inclusion criteria 
were enrolled for this study. This study was single-
blind pilotstudy (Figure 1).
2.3 Administration of drug:  
Research drug was given twice a day in the form 
of capsule after meal for the period of 45 days.
2.4 Assessments:
All the patients were assessed fortnightly for 
subjective parameters (0th, 15th, 30th, and 45thday) 
whereas objective parameters were assessed 
before and after the treatment.
2.5 Adverse Drug Effect:
Throughout the course of trial, there wasno any 
adverse effect was reported.

Figure 1:Flow diagram of the trial.

2.6 Statistical analysis:
Statistical analysis was performed using SPSS 
15.0, used to analyze the data and use Microsoft 
Word and Excel to create graphs, tables etc.The 
findings were statistically calculated using student 
t test, combined proportion test and exact Fischer 
test.Significance is measured at the level of 5%. 
Results were based on continuous measurements 
as Mean ± SD (Min-Max).
3. Results:
Baseline characteristics
The demographic characteristics of subjects were 
in baseline characteristics including age, genders, 
and dietary habits (Table 1).
Table 1: Distribution of the patients according to 
demographic details.

Variables Oxy+ Group Total (n=10)

Age in years

39-45 4 4(40%)
46-52 1 1(10%)
53-60 5 5(50%)
Total 10 10(100%)

Mean ± SD 50.4±7.42 50.4±7.42

Gender
Female 7 7(70%)
Male 3 3(30%)
Dietary Habits
Mixed Diet 9 9 (90%)
Vegetarian 1 1(10%)
Total 10 10(100%)

a Student t test, bFisher Exact Test, cChi-Square Test, 
*Significant



International Journal of Human and Health Sciences Vol. 05 No. 01 January’21

98

Primary Outcome
The objective parameter was assessed before 
and after as Mean ± SD for FBS (164.4±36.019 
vs 111.1±25.075), PPBS (248.5±51.70 vs 
170.1±45.148) and HbA1c (9.14±1.517 vs 
6.95±1.224) (Table 2).
Table 2: Evaluation of objective variables before 
and after treatment.

Variables Before Treatment
After 

Treatment Difference P value

FBS (mg/dl) 164.4±36.019 111.1±25.075 53.3 <0.0012**

PPBS(mg/
dl)

248.5±51.70 170.1±45.148 78.40 <0.0001**

HbA1c (%) 9.14±1.517 6.95±1.224 2.19 <0.0008

Student t test (two tailed, dependent) has been 
used
Secondary Outcomes
All safety profile was found safe from baseline to 
end of the trial without any adverse effect (Table 
3).
Table 3: Evaluation of safety variables.

Safety 
variables

Before 
Treatment

After 
Treatment Difference P value

SGOT (mg/

dl)
26.5±7.82 29.9±11.43 -3.400 <0.265

SGPT (mg/

dl)
28.4±7.619 34.4±9.27 -6.0 <0.073

Blood Urea 

(mg/dl)
9.14±1.517 6.95±1.224 2.19 0.566

Serum 

Creatinine 

(mg/dl))

9.14±1.517 6.95±1.224 2.19 <0.0008

Student t test (two tailed, dependent) has been 
used
Discussion:
Diabetes mellitus has become an observably global 
public health problem.29 Migration from rural 
areas to urbanization and a sedentary lifestyle; 
changes in food habits may increase the risk of 
obesity and diabetes.30 Physical activity increases 
glycemic regulation and decreases the risk of 
cardiovascular disease (CVD) and death in type 2 
diabetes patients.31According to the International 
Diabetes Foundation (IDF) statistics, presently 
every seven seconds someone is estimated to 
die from diabetes or its complications, with 50% 
of those deaths.32 A combination of lifestyle 
changes and pharmacological therapy is required 
to maintain good metabolic control in diabetes 
and to keep the patient stable for the long 

term.33,34 Hozayen WG et al, (2016) reported that, 
Arthrospira (spirulina) exhibits insulin-mimetic 
and anti-diabetic activity.35 
One other study documented that, spirulina is a 
rich source of fiber contents which may lead to 
reduced glucose absorption and possible action of 
peptides, and polypeptides generated by digestion 
of spirulina protein are responsible for it.36 Layam 
A et al,23 Alam et al,24 Park HJ et al,25 Lee EH et 
al, 26Anitha L et al,27 Kumari P  et al,37 and Kaur 
K et al,38 reported that Spirulina exhibits as an 
anti-hyperglycemic activity. Parikh P et al,36 and 
Anweret al,39 reported that Spirulina provides 
a plentiful source of proteins and it is well 
recognized that ingestion of protein and amino 
acids stimulates the secretion of insulin. This effect 
may be responsible for the reduction in fasting, 
postprandial blood sugar, and HbA1c.36,39 Various 
hypotheses that, about spirulina, which is a rich 
iron source, led to high hemoglobin levels. The rise 
in hemoglobin levels may have been attributed to 
the dropin blood glucose levels, which would also 
lead to a drop in glycosylated hemoglobin.23,36,39,40
Limitations of the study:
The limitations of the present study include lack 
of a control group and blinding. Moreover, it was 
a small sample size.
 Conclusion:
Accordingly, it can be concluded that Oxy+ has a 
beneficial effect on reducing fasting blood sugar 
(FBS), postprandial blood sugar (PPBS) and 
glycosylated hemoglobin (HbA1c). Consequently, 
it can be concluded that the ‘Oxy+’ would be 
safe and effective in the management of type 2 
diabetes.
Acknowledgement: We would like to extend our 
sincere gratitude and appreciation to participants 
of this study.
Funding : Supported by Alberto 
FridolphoProduzioneOranjestad, Aruba.
Conflict of interest : The authors declare no 
conflict of interest.
Ethical approval issue:Prior ethical approval 
was taken from Institutional Ethics Committee.
Authors’ contribution: Conception and design 
of the study: Md AnzarAlam.Data collection 
and compilation: Mariyam andFasihur Rehman 
Ansari.Data analysis: Farooqui Shazia Parveen.
Critical writing, revision and finalizing the 
manuscript: MohdAleemuddinQuamri.



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