Preclinical and clinical study of siddha drug “Vaatha Chooranam” (Internal) and “Vaatha Mega Narayana Ennai” (External) in the treatment of “VazhiAzhal Keel Vaayu” (Rheumatoid Arthritis)

The disease Vali Azhal Keel Vaayu was taken for the clinical study with Vaatha Chooranam as internal medicine and Vaatha Mega Narayana Ennai as external application. For the clinical study, 40 cases were selected based on the approved protocol. This study has been approved by IEC of NIS [Date of IEC Approval & its number: NIS/IEC/9-2014-15/12-26.08.2015]. Animal studies were carried out after obtaining approval from the Institutional Animal Ethical Committee (IAEC) and the trial was registered in Clinical Trial Registry of India (CTRI/2017/05/008594.) Hence the study is safely executed on patients and there was no adverse drug reactions noted during the study period. The toxicological evaluations were conducted as per WHO guidelines for safety evaluation of Vaatha Chooranam. In short term and long term toxicity study, no signs of toxicity and mortality were observed through out the study. In organs of Control group, no abnormality was detected. The normal histological structure present in test group of animals. 40 cases, were treated with trial medicine in OPD, IPD of Department of Sirappu Maruthuvam, Ayothidoss Pandithar Hospital of National Institute of Siddha, Chennai-47. The detailed study on Vaatha Chooranam with reference to its aetiology, pathogenesis, investigations, clinical features, diagnosis and treatment with trial drugs were done. The patients were diagnosed and included on the basis of EULAR (European league Against Rheumatism scale) and the results were observed by Pain scale and restricted movements scale before and after treatment. Among the 40 cases treated, 42.5%% cases shows Good improvement, and 50% shows Moderate improvement 7.5% shown Mild improvement. CONCLUSION: This study proved that the formulation given good results in many patients through clinical trials and it may be better solution for reducing the pain, swelling and restricted movements. This brought confident in rheumatoid patients which increases the quality of life. No adverse effects were noted during the course of treatment. Short term and long term study of the trial drug is safe, it does not produce any toxic effects in rats. This shows that the trial drug Vaatha Chooranam (Internal) and Vaatha Mega Narayana Ennai (External) both is safest drug for human beings