Vedanahara.cdr O ISSN : 2693 6356 2018 | Vol 1 | Issue 3 Osteoarthritis Pain Reduction with Ajamodadi Vati (An Ayurvedic Formulation) Totar 1, Shakuntala, Shiva Rama Prasad Kethamakka Abstract Background: Formerly known as degenerative joint disease, osteoarthritis (Sandhigata Vata) is now classified as a disease of the Vata humor in Ayurveda. Vata, Kapha, and Sleshmadhara Kala (the joint mucous membrane) are the key Doshas (humors) involved in the pathophysiology of age- related degenerative joint disease. Sandhigata Vata Ajamodadi Vati (an Ayurvedic preparation) will be studied for its analgesic effects. Substances and Techniques: Thirty patients who met the study's requirements participated for a total of 30 days. In the experiment, the medication was given at a daily dosage of 3 grams. The findings revealed that the trial medicine was statistically significant in reducing the complaints measured by both subjective and objective indicators (with the exception of swelling). The trial medicine Ajamodadi Vati showed excellent analgesic impact against osteoarthritis pain, the results revealed. Keywords: Osteoarthritis, Ajamodadi Vati, Sandhigata Vata, and Analgesic Effect Introduction steoarthritis (OA) is the most prevalent musculoskeletal disorder in the world (30%) after back pain ( 50 %). The reported prevalence of osteoarthritis in rural India is (5.78%). Among 80% of world population the prevalence is usually seen in the age group of 60-65 yrs with some radiological evidences[1,2]. It is the most common form of joint disorder amongst the elderly and obese persons which is a major cause of morbidity and chronic disability as well as burden on health care resources especially for the elderly. This disease keeps an insidious attack, which runs for many years causing the loss of function as well as deformity of the joints. Elderly osteoarthritis is the leading cause of chronic disability and some 1,00,000 people in the United States are unable to walk independently from bed to bathroom because of OA[3]. In Ayurveda the condition is equated to Sandhivata or Sandhigata Vata. Even though Sandhigata Vata is not mentioned in Vedic literature, Acharya Charaka, Madhavakara, etc. have dealt this condition under the context of Vata Vyadhi. Sandhigata Vata is also commonly called as Sandhivata . Medicine, a large number of people suffer from OA all over the world without a permanent relief from this disease. It is said that current treatment for osteoarthritis is purely based on control of symptoms because there is no disease modifying osteoarthritis drug yet. Intra-articular steroids are widely used, even though they provide marked relief from symptoms but they loose their effect within weeks to months. Ayurveda opines that Vyadhi (disease) is a condition in which body suffers from pain. Hence it is believed that reliving the pain is the main treatment to state that the disease is subsided. It is clear to state that Vedana (pain) and Shotha (swelling) are the main features of Sandhigata Vata, wherein Vedanahara and Shothahara are the drugs of choices. Ajamodadi Vati is i n d i c a t e d f o r t h e Sandhivata b y Acharya Yogaratnakara. Out of the composition of the drug Sunthi, Vruddhadaru and Ajamoda are known analgesics. Thus in this study an effort is being made Ajamodadi Vati as Lakshanika Chikitsa (symptomatic management) in Sandhigata Vata especially in reliving pain. Materials & Methods: In the present study the investigators objective was to study the of trial drug as determined by the difference between the baseline data of the parameters to the after treatment data. a) Study Design: Preliminary open clinical study b) Source of data, Sample Size and Grouping: Patients suffering from osteoarthritis were selected from Dept. of K.C., P.G.S. & R. C., OPD, of Shree D.G.M.A.M.C. & H. Gadag, Karnataka. 30 patients in a single group. e) Duration of Study : 30 days f) Selection Criteria: Exclusion criteria:  Patients below 30 years and above 70 year of age  Pregnant woman & lactating mother.  Associated with simple or compound fractures.  Associated with any other systemic or metabolic disorders.  Patient on steroid therapy  Patient under gone surgery Inclusion criteria:  Patients suffering from the symptoms of Sandhivata (Osteoarthritis) of one year  Patients of either gender aged between 30-70 years are included-as the condition is commonly found in the either sex, but not to the old age. g) Parameters: Subjective Parameters: 1) Prasarana Akunchana Pravruti Vedana (Pain during and extension of joints) Grade 0 – No Complaints Grade 1 – Tells on Enquiry c) Trial drug: Ajamodadi Vati [4] containing 10 ingredients (table-1). Grade 2 – Complains Frequently Grade 3 – Excruciating Condition Table 1: Depicting the ingredients of Ajamodadi Vati SNo Sanskrit Name Latin Name Quantity 1 Ajamoda Apium 1 Tola leptophyllum 2 Pippali Piper longum 1 Tola 3 Velam Embelica rebes 1 Tola 4 (Vayuvidanga) Shatapushpa Foeniculum 1 Tola vulgare 5 Chitrakamoola Plumbago zeylanica 1 Tola 6 Shunti Zingiber officinale 1 Tola 7 Haritaki Terminalia chebula 1 Tola 8 Vrudhadaruk Ipoemia petalodea 1 Tola 9 Saindhava Rock salt 1 Tola Lavana 10 Guda Jaggery Q.S. d) Dose: 3 gms/24 hrs in divided doses (1 gm TDS) 2) Sandhi Graha (stiffness) Grade 0 – Absent Grade 1 – Present 3) Sparsha Akshamatva (pain by touch) Grade 0 – No Complaints Grade 1 – Says the joint is tender Grade 2 – Winces the affected joint Grade3 – Winces and withdraws the affected joint 4) Shotha (Swelling) Grade 0 – No Complaints Grade 1 – Slightly obvious Grade 2 - Covers well over the bony prominence Grade 3 - Much elevated 5) Vatapoorana Druti Sparsha (Bursitis) Grade 0 – No Bursitis Grade 1 – Minimum Bursitis observed Grade 2 - Moderate Bursitis observed Grade 3 - Prominent Bursitis observed Objective Parameters 1) Joint pain: grading was based upon the moderate universal pain assessment tool which is a visual analogue scale to assess pain in patients. 2) Pain assessment through standardized Mc Gill's questionnaire 3) Swelling: was measured with a tape and graded 4) Walking time: to cover 21 meters was recorded and grades. Grade 0 – Up to 20 seconds Grade 1 – 21-30 seconds Grade 2 - 31-40 seconds Grade 3 – 41-50 seconds Grade 4 – 51-60 seconds I) Ethical Clearance: was obtained from Institutional Ethics Committee after which the study was started. Results: A total number of 170 patients were scrutinized at Table 2 : Evaluation of Pain Complaints % of patients effected Sandhi Shotha 96.66 Prasarana Akunchana Vedana 100 Sandhi Graham 93.33 Sparsha Akshamatwa 80 Nature of Pain Pricking 10 Aching 43.33 Generalized 46.66 The joints involved in the majority of patients were Knee joint (70%), interphalangeal joints (46.6%), Ankle (26.66%), Lumbar Spine (16.66%), Cervical and Axial (6.66%). C) Assessment of the effect Post treatment the trial drug showed 55.44% relief in pain due to Prasarana & Akunchana, 23.25% relief in Sandhi Graha, 43.08% relief in Sparsha Akshamatwa and 38.57 % relief in Sandhi Shotha (Table 3). Table 3: Effect of trial drug on Pain OPD level and 30 patients were enrolled for the study randomly. All the 30 patients completed the stipulated duration of 30 days and no dropouts were Parameter Prasarana Mean Score BT Mean Score AT Mean Difference % Improvement reported. a) Gender and Age the gender because the prevalence of Sandhigata Vata is common in both males and females, but females may be more prone to osteoporosis in post Akunchana Vedana Sandhi Graham Sparsha Akshamatwa 1.93 0.86 1.07 55.44 0.86 0.66 0.2 23.25 1.23 0.7 0.53 43.08 menopausal period. Conceptually age certainly has effect because as the age advances there is Kapha Kshaya (Decrease of humor Kapha) and Vata Vruddhi (Increase in humor Vata). Patients aged 50-60 years dominated the study. However an early onset of the disease was also noted in the age group of 30-40 years. The effect of drug on gender revealed that 7 out of 12 males and 9 out of 18 females had moderate response. b) Evaluation of pain data Among 30 patients all of them reported with pain of variable intensity. 100% of patient experienced pain during & extension of the affected joint, 96.67% of them had joint swelling, 93% of them had stiffness which restricted their activities and nearly 80% patients reported pain by touch (Table 2). 46.66% of patients experienced generalized pain. 43.33% of patients were noted by aching type of pain and 10% of people with burning type of pain (Table 2). The trial drug Ajamodadi Vati showed statistically result in alleviating Vatapurna Driti Sparsha, Sandhi Shota (Subjectively) and Joint Pain. Walking time also improved with improvement in MC Gills Pain assessment questionnaire. However Swelling evaluated objectively by measuring did not show any signi difference statistically (Table 4). Discussion Sandhigata Vata even though is explained as one of the derivatives of Vata there is no Nidana (etiology) explained and is most of the time related to ageing. There is an intimate relation between Vata and Kapha in Sandhigata Vata. Restoration of Vata to its normal state helps in the management of Sandhigata Vata. J. Res. Trad. Medicine | Jan-Feb 2016 | Volume 2 | Issue 1 Table 3: Statistical assessment on effect of trial drug on Subjective & Objective Parameter Sl Parameter Mean Mean % of SD SEM t value P Value Significance no BT AT Improv ement 1 Vataporna Driti 1.033 0.466 54.88 0.568 0.103 5.504 <0.001 HS 2 Sparsha Sandhi Shota 1.4 0.9 35.71 0.572 0.104 4.807 <0.001 HS 3 Joint pain 7.766 2.1 73.50 1.268 0.231 24.502 <0.001 HS 4 Swelling 309.53 309.06 05.25 9.722 1.775 00.262 <0.40 NS 5 Walking time 2.633 1.566 40.52 0.365 0.066 16.16 <0.001 HS 6 MC Gills Pain 13.10 Questionnaire 09.16 30.00 1.874 0.0003 13.13 <0.001 HS In present study maximum numbers of patients belonged to age group of 50-60 years, which is Vata predominance and the symptoms of joint pain is being age related. The combination Ajamodadi Vati is said to be possessing Vedanahara (analgesics) effect by virtue of its pharmaco-dynamic properties [5]. The main Dosha in Sandhivata is Vata, with degeneration of joints being one of the components. The combination of the trial drug not only acts as a pain reliever but also acts on Ama (Biological waste) with its Deepana (carminative) and Pachana (digestive) properties [5] . Ajamodadi Vati 2. Anthony D. Woolfet, et al. Burden of major musculoskeletal conditions. Bulletin of the World Health Organization. 2003, 81 (9):646- 656 3. R. D. Altman. Three- of acetaminophen extended-release for osteoarthritis pain of the hip or knee: a randomized, double- blind, placebo- controlled study. Osteoarthritis and Cartilage. 2007, 15:454-461 4. Vaidya Lakshmipati Sastri, editor. Yoga Ratnakar with Vidyotini Hindi commentary, with its ingredients express anti- and Kashi Sanskrit Series 160, 6th ed. Varanasi; analgesic action by regulating the Shleshmadhara Kala Shotha joints). Conclusion The results of the preliminary pilot study suggest that the trial drug when used in Sandhigata Vata produces a Vedhanahara (Analgesic) effect by virtue of the pharmaco-dynamic properties possessed by its ingredients. However a clinical study with larger sample size and for longer duration may be helpful in understanding the exact mode of the action. The also be assessed to know its References: 1. Aksel Schreiner. Text book of Maritime Medicine. [Internet]. 2nd ed. Norwegian Centre for Maritime Medicine, Bergen; 2013. [Cited on 21-10-15]. Available from: http://textbook.ncmm.no/index.php/text book-of-maritime medicine/31-textbook-of- maritime medicine/29-soft-tissue-and-joint- injury/732-291- introduction Chaukhambha Sanstan; 1997, p.542-543. 5. J L N Shastry. Dravyaguna Vigyana Vol- II. 2nd ed. Varanasi; Chaukambha Orientalia; 2004, p.265-267. http://textbook.ncmm.no/index.php/text