An open clinical study to evaluate the efficacy of Siddha Polyherbal Medicine Sarvanga vatha chooranam(Internal), Mukkutu Yennai(External) and Otradam(External therapy) for the treatment of Santhuvatham(Polyarthritis)

STUDYENROLLMENT:

Patientreporting at the OPD Of Govt,Siddha medical college and hospital, palayamkottaiwith clinical features of pain in more than three joint, stiffness are chosenfor enrollment based on the inclusion criteria.

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

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

ScreeningForm-I will be filled Up: Form-III Form-IV and Form V will be used forrecording the patients, history clinical examination of symptoms, signs andlaboratory investigations  respectively.Patients will be advised to take the trial drug. Appropriate dietary advicewould be given to the patient.

CONDUCTOF THE STUDY

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

InIPD patients the clinical assessment will be made daily and recorded in theappropriate forms

Forout-patients the trail will be given in the Outpatient Department of PGSirappuMaruthuvam (Room no: 4) of our hospital. The Out-patient will be askedto have a regular follow-up in the OP Department once in 7 days.  In each and every visit, the clinicalassessment will be recorded in the prescribed proforma. The laboratoryinvestigations will be done before and after treatment and recorded in theprescribed format. At the end of the trial the patients are advised to havefollow-up for 2 more months for observing any recurrences. Defaulters will notbe allowed to continue and will be withdrawn from the study.

 DATAANALYSIS:

Afterenrolling the patients for the study, a separate file for each patient will beopened and all forms will be kept in the file. Study No. and patient’s identityNo. will be written on the top of the file for easy identification. Wheneverstudy patient visits OPD during the study period. The respective patient filewill be taken and  necessary entries willbe made at the assessment form or other suitable form.. The screening formswill be filled up separately. The data recordings will be  monitored by the Head of the Department andPharmacovigilance committee. All forms will be further scrutinized in presenceof investigators with concerned department faculties for logical errors and incompleteness of data to avoid any bias. No modification in the results is permitted forunbiased report.