STUDY ENROLLMENT:

             Patients reporting at the OPD of Govt. Siddha Medical College and Hospital,Palayamkottaiwith the clinical symptoms of Pain and swelling of both knee joints, stiffness, restricted movements of both knee joints, warmth, tenderness, inability to squat in the Indian toilet etc., 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 if 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 drug and appropriate dietary advice (Form IV-D) perfect understanding.

CONDUCT OF THE STUDY:

Before starting the treatment purgation is given with the op medicineVellai ennai-15ml with hot water in the early morning(empty stomach).

The trial drug “KALINGA MATHIRAI”(INTERNAL), “KODIVELI THYLAM” (EXTERNAL) and external therapy PATTRU is given continuously for 30 - 48 days.  OP patients should visit the hospital once in a eight days.  At each clinical visit clinical assessment is done and prognosis is noted.  For IP patients the drug is given for 30 - 48days.  Laboratory investigations & radiological investigation are done 1^st day, 24th and 48th day of the trial.  For IP patients, who are not in a situation to stay in the hospital for a long time are advised to attend the OPD for further follow-up.  After the end of the treatment, the patient who fails to collect the trial drug on the prescribed day but wants to continue the trial from the next day or two, he/she will be allowed, but defaulters of one week and more will not be allowed to continue and be withdrawn from the study with a fresh cash being included.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 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 enteries will be made in the assessment form or in other suitable form.  The screening forms will be filled separately.  The data recordings will be monitored for completion and adverse event by HOD and pharmacovigilance committee.  All forms will be further scrutinized by Sr. Research Officer (Statistics) for logical errors and incompleteness of data to avoid any bias.  No modification in the results is permitted for unbiased report.