AN OPEN LABELLED NON- RANDOMIZED PHASE II COMPARATIVE CLINICAL TRIAL TO EVALUATE THE THERAPEUTIC EFFICACY OF PATTRU [EXTERNAL THERAPY] AND KEELVAYU NIVARANA CHOORANAM [INTERNAL] FOR AZHAL KEEL VAYU [OSTEOARTHRITIS].

STUDY ENROLLMENT:

In this clinical trial, patient reporting at GSMCH,OPD with the clinical symptoms of both knee joint pain, swelling, tenderness, stiffness, crepitation, restricted movement of both knee joint will be clinically examined and enrolled  in the study based on the inclusion and exclusion criteria.

The patient who are to be enrolled in this study will be informed about the     objective of the study, Pattru application, possible outcomes in their own language and terms understandable to them

·        .

·        After ascertaining the patient willingness, consent will be obtained in the informed consent form.

·        Complete clinical history complaints and duration, examination findings-all will be recorded in the prescribed Performa and clinical assessment forms separately. Screening form and laboratory investigation form filled separately.

·         All the patients will be given unique registrations card in which patients registrations number, address, phone number will be entered. Doctors phone number  etc. will be provided in the card  to report in case of emergency.

·        Patients will be advised to undergo trail and appropriate dietary advice will be given according to the patients  perfect understanding.

CONDUCT OF THE  STUDY:

·        The trial drug and therapy will be given continuously for 48 days.

·        OPD patients are requested to visit the hospital daily. Clinical assessment and prognosis will be noted at first and last clinical visit. For IP patients, the drug is provided daily and clinical assessment will be noted daily. Laboratory  investigations will be done in 0th  day and 48th  day of the trail. For IP Patients who are not in positions to stay in the hospital for long time are advised to attend the OPD for further follow up. At the end of the treatment also, the patients are advised to visit the OPD for further 2 months follow up.

·        If any trail patient fails to take the trail drug on the prescribed day or even next day but wants to continue in the trail from the next day he/she will be allowed. But defaulters of one week will not be allowed to continue and will be withdrawn from the study.

DATA MANAGEMENT:

Ø After enrolling the patient in the study, a separate file for each patient will be opened and all forms will be filed in the file. Study number and Patient number will be entered on the top of the file for easy identifications. Whenever the study patients visits OPD during the study period, the respective patient file will be taken and the necessary recordings will be made at the case record form or other suitable form.

Ø The screening form will filed separately.

Ø The Data recordings, and adverse events if any, will be monitored by the HOD and department of pharmacovigilance. All forms will be further scrutinized and no modifications in the results will be permitted for unbiased reports.