An open comparative clinical evaluation on Uthira Vatha Suronitham (Rheumatoid Arthritis) with Siddha Trial Drugs Rasa Chendhuram (Internal) and Roga Sanjeevi Thylam (External) & Ottradam Theraphy

Clinical study on safety and efficacy of RASA CHENDHURAM internally and ROGA SANJEEVI THYLAM externally with OTTRADAM therapy in UTHIRAVADHA SURONIDHAM has been chosen for my dissertation work. Various literatures dealing with Rheumatoid arthritis had been collected from siddha and modern text book as well as drug review was mentioned in my dissertation. Standardization of drug RASA CHENDHURAM through both traditional and modern techniques. Quantitative and qualitatitive analysis of trial drug Rasa chendhuram was carried out, along with heavy metal analysis and physic-chemical analysis. Acute and sub-acute toxicity of trial drug RASA CHENDHURAM was carried out in Wister albino rats after obtaining proper permission from institutional animal ethical committee. Pharmacological activity, in vitro immune-modulatory activity for the trail drug RASA CHENDHURAM was using cell line RAW 264.7. Anti-inflammatory activity for the trial drug RASA CHENDHURAM was carried out left hind paw oedema volume. The clinical trial was conducted to evaluate the efficacy of the trial drugs RASA CHENDHURAM (INT), and ROGA SANJEEVI THYLAM THYLAM (EXT) WITH “OTTRADAM THERAPY in Rheumatoid arthritis patients, after getting proper approval from institutional ethical committee. The sample size was 40 patients, the duration was 24 days. 20 patients were treated with internal and external medicine. (Group I), 20 patients were treated with internal and external & ottradam theraphy (group II). The internal drug RASA CHENDHURAM was administered at the dose of 65mg twice daily, with honey. In my clinical trial some patients had Anti-CCP negative while before treatment, even though their clinical symptoms matched with my inclusion criteria, I also added them to my clinical trial. All the details about the study and the drugs were informed to the patients in their vernacular language and consent forms duly signed by them were obtained from them. Separate proforma was maintained for each and every patient. The clinical improvement was assed using pain score. Safety of the trial drug RASA CHENDHURAM was assessed by comparing the safety parameters LFT & RFT before and after treatment. Finally the statistical analysis was performing to assess the significance of the clinical trial. CONCLUSION: This study was conducted with the siddha medicines “RASA CHENDHURAM” (Internal) and ROGA SANJEEVI THYLAM (External). These medicines are indicated for vatha diseases in siddha texts. Heavy metal analysis of RCM reveal that the drug does not contain any metals like lead, cadmium, arsenic, mercury. The acute and sub acute toxicity study reveals that the trial drugs RCM is safe, sub –acute toxicity studies two doses were administrated orally for 28 days Animals were observed for physiological and behavioural changes food and water, intake body weight, mortality. All the animals were sacrifices, the changes in organ weight and histology were examined no mortality were observed and no treatment related changes seen. Hence the siddha trial drugs RCM is safe in animal models While the concentration level is decreased, nitrate level is increased. Hence 25μg/ml of Rasa Chendhuram has rich level of nitrate and thus proven to be an IMMUNOMODULATOR. Anti inflammatory activity using in RCM . The paw volume was measured at 1, 2, 3, 4 and 5hr using Plethysmometer (Model 7150 UGO Basile, Italy) Edema was expressed as the mean increase in paw volume relative to control animals. Among the study sample 80%had good improvement, 10% had moderate improvement, and 10% had mild improvement. The results of the study reveal the fact that these medicines are efficacious in reducing morning stiffness, pain and swelling, restricted movement, in uthira vatha suronitham with assessing all the safety parameters of blood before and after treatment. OTTRADAM therapy along with siddha trial drugs was very effective as the overall improvement was good and to certain extent earlier in the subjects who were given ottradam theraphy. Many of these subjects had reduction or relief from morning stiffness, pain and restricted movements for about four to five hours manipulating the ottradam therapy. The LFT &RFT before and after treatment does not show any significant change in rheumatoid cases hence it is safe in human trial. In my clinical trial during the course of the trial there were no adverse effect or unwanted drug reactions in GIT, RS, CVS and excretory system. Hence the siddha trial drug “RASA CHENDHURAM” Internal medicine is proved to be a potential Anti-Rheumatoid and “ROGA SANJEEVI THYLAM” with Ottradam theraphy externally are effective in reducing morning stiffness, pain and swelling of the joints, restricted movements in uthira vatha suronidham. (Rheumatoid Arthritis)