STUDY ENROLLMENT:

          Patient reporting at the OPD Of Govt,Siddha medical college and hospital, palayamkottai with clinical features of pain in more than three joint, stiffness are chosen for enrollment based on the inclusion criteria.

          The patient who are enrolled will be informed  about the study, trial drug, possible outcomes and the objectives of the study and terms in the language and understandable to them and the informed consent would be obtained in writing form them in the consent form (Form II)

          All these patients will be given unique registration card in which the patient Registration to the study, Address, phone number and Doctors phone number etc. will be given, so as to report easily of any complications arise. Complete clinical history, Complaints, duration, examination findings and laboratory investigations- will be recorded in the prescribed Proforma.

          Screening Form-I will be filled Up: Form-III Form-IV and Form V will be used for recording the patients, history clinical examination of symptoms, signs and laboratory investigations  respectively. Patients will be advised to take the trial drug. Appropriate dietary advice would be given to the patient.

CONDUCT OF THE STUDY

          On the first day of the treatment Purgation will be given with Vellai Ennai-15 ml early morning for balancing the dearranged thathus. The next day onwards the trial drugs sarvangavatha chooranam(internal) and mukkutu yennai (external)  will be given for 30-40 days.

          In IPD patients the clinical assessment will be made daily and recorded in the appropriate forms

          For out-patients the trail will be given in the Outpatient Department of PG SirappuMaruthuvam (Room no: 4) of our hospital. The Out-patient will be asked to have a regular follow-up in the OP Department once in 7 days.  In each and every visit, the clinical assessment will be recorded in the prescribed proforma. The laboratory investigations will be done before and after treatment and recorded in the prescribed format. At the end of the trial the patients are advised to have follow-up for 2 more months for observing any recurrences. Defaulters will not be allowed to continue and will be withdrawn from the study.

DATA ANALYSIS:

          After enrolling the patients 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’s identity No. will be written on the top of the 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 filled up separately. The data recordings will be  monitored by the Head of the Department and Pharmacovigilance 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.