An Open Clinical Study to evaluate the efficacy of Siddha polyherbal medicine Keelvayu Nivarana Chooranam(Internal), Vathathirku Thylam(External) and Vedhu(External Therapy) for the treatment of Uthiravatha Suronitham(Rheumatoid Arthritis)

Study enrollment:

Patientsreporting at the OPD of Govt. Siddha medical college and hospital, Palayamkottai.With the clinical symptoms  theSymmetrical joint involvement, Arthrits of 3 or more joints, morningstiffness  Swelling especially in theinter phalangeal joints, will be examined clinically for enrolling in the studybased on the inclusion and exclusion criteria.

The patients who are to be enrolledwould be informed (form iv) about the study, trial drug, possible outcomes andthe objectives of the study in the language and terms understandable to them.

After ascertaining the patient’swillingness, informed consent would be obtained in writing from them in theconsent form (form iv).  All thesepatients will be given unique registration card in which patient’s registrationnumber of the study, address, phone number and doctor’s phone number etc., willbe given, so as to report easily should any complications arise.

complete clinical history,complaints and duration, examination findings—all would be recorded in theprescribed proforma in the history and clinical assessment forms separately.  Screening form – i will be filled up.   Form – ii and form – iii will be used forrecording the patient’s history, clinical examination of symptoms and signs andlaboratory investigations respectively. Patients would be advised to take the trial drug and appropriate dietaryadvice (form iv-d) would be given according to the patient’s perfectunderstanding.

Conduct of the study:

15ml of Vellai ennai is given inearly morning, on the very first day of treatment for purgation. This will helpto bring the vitiated mukkutram back to normal. From the next day, the trialdrug is given for treatment.

Thenthe trial drug KEELVAYU NIVARANACHOORANAM (internal), VATHATHIRKU THYLAM (external) is givencontinuously for 30 to 48 days. OP patients should visit the hospital once in sevendays.  At each clinical visit clinicalassessment is done and prognosis is noted. For IP patients the drug is given for 40 days and the clinicalassessment is done daily. patients will be given Vedhu (steam bath) treatmentalong with their internal medicine. The results will be compared at the end ofthe study. Laboratory investigations & radiological investigation are done0 day, 20th day, 40th day of the trial. For IP patients,who are not in a situation to stay in the hospital for a long time is advisedto attend the OPD for further follow-up. After the end of the treatment, thepatient is advised to visit the OPD for another 2 months for follow-up. If anytrial patient who fails to collect the trial drug on the prescribed day butwants to continue in the trial from the next day , he/she will be allowed, butdefaulters of one week and more will not be allowed to continue and be withdrawnfrom the study with a fresh case being included.

 Data management:

After enrolling the patient for thestudy, a separate file for each patient will be opened and all forms will bekept in the file.  Study No. and patientidentity No. will be written on the top of file for easy identification.  Whenever study patient visits OPD during thestudy period, the respective patient file will be taken and necessary entrieswill be made at the assessment form or other suitable form.  The screening forms will be filed separately.  The data recordings will be monitored by HODand pharmaco-vigilance committee.  Allforms will be further scrutinized in presence of investigators with concerneddepartment faculties for logical errors and incompleteness of data to avoid anybias.  No modification in the results ispermitted for unbiased report.