Study enrollment:

Patients reporting at the OPD of Govt. Siddha medical college and hospital, Palayamkottai. With the clinical symptoms  the Symmetrical joint involvement, Arthrits of 3 or more joints, morning stiffness  Swelling especially in the inter phalangeal joints, will be examined clinically for enrolling in the study based on the inclusion and exclusion criteria.

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

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

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

Conduct of the study:

            15ml of Vellai ennai is given in early morning, on the very first day of treatment for purgation. This will help to bring the vitiated mukkutram back to normal. From the next day, the trial drug is given for treatment.

Then the trial drug KEELVAYU NIVARANA CHOORANAM (internal), VATHATHIRKU THYLAM (external) is given continuously for 30 to 48 days. OP patients should visit the hospital once in seven days.  At each clinical visit clinical assessment is done and prognosis is noted.  For IP patients the drug is given for 40 days and the clinical assessment is done daily. patients will be given Vedhu (steam bath) treatment along with their internal medicine. The results will be compared at the end of the study. Laboratory investigations & radiological investigation are done 0 day, 20^th day, 40^th day of the trial. For IP patients, who are not in a situation to stay in the hospital for a long time is advised to attend the OPD for further follow-up. After the end of the treatment, the patient is advised to visit the OPD for another 2 months for follow-up. If any trial patient who fails to collect the trial drug on the prescribed day but wants to continue in the trial from the next day , he/she will be allowed, but defaulters of one week and more will not be allowed to continue and be withdrawn from the study with a fresh case being included.

Data management:

            After enrolling the patient for the study, a separate file for each patient will be opened and all forms will be kept in the file.  Study No. and patient identity No. will be written on the top of file for easy identification.  Whenever study patient visits OPD during the study period, the respective patient file will be taken and necessary entries will be made at the assessment form or other suitable form.  The screening forms will be filed separately.  The data recordings will be monitored by HOD and pharmaco-vigilance committee.  All forms will be further scrutinized in presence of investigators with concerned department faculties for logical errors and incompleteness of data to avoid any bias.  No modification in the results is permitted for unbiased report.