An open clinical study to evaluate the efficacy of Siddha Monoherbal Medicine Kottai Karanthai Chooranam (Internal), Semparuthi Poo Ennai (External) and Yoga Therapy for the treatment of Kalanjaga padai (Psoriasis)

Study Enrollment:

Patientsreporting at the Out Patient Department (OPD) of Govt. Siddha Medical Collegeand Hospital, Palayamkottai with the clinical symptoms of erythematous patches,scaling, itching will be examined clinically to enroll in the study based onthe inclusion and exclusion criteria.

Thepatients who are being enrolled would be informed about the objectives of the study,trial drug, possible outcomes in the language and terms understandable to them.After ascertaining the patient’s willingness, informed consent would beobtained in writing from them.

All these patients willbe given unique registration card in which patient’s registration number of thestudy, address, phone number and doctors phone number, etc. will be given, soas to report easily if any complications arise. Complete clinical history,complaints and duration, examination findings - all would be recorded in theprescribed history proforma and clinical assessments forms separately.

Laboratoryinvestigations are done periodically and are reported in the respective form. Patientswould be advised to take the trial drug and appropriate dietary advice would begiven according to the patient’s perfect understanding.

Conductof the study:

Onthe first day of the treatment, purgation (vellai ennai 15ml) will be givenearly morning for balancing the deranged thathus. From the next day, the trialdrug KOTTAI KARANTHAI CHOORANAM (Internal (4grams) – twice/day), SEMPARUTHI POOENNAI (External) is given continuously for 40 days. OPD Patients should visitthe hospital once in 5 days. At each clinical visit, clinical assessment is doneand prognosis is noted. The In Patient Department (IPD) patients are provided withInternal and External medication along with Yoga therapy and prognosis isnoted. Clinical assessment is noted daily. Laboratory investigations are done on 0th day, 20thday, and 40th day of the trial. IPD patients, who are not in a situation tostay in the hospital for a long time is advised to attend the OPD for follow-up.At the end of the treatment, the patient is advised to visit the OPD foranother 2 months for further follow-up. If any trial patient who fails tocollect the trial drug on the prescribed day but wants to continue in the trialform the next day, he/she will be allowed, but defaulters of one week and morewill not be allowed to continue and be withdrawn from the study with a freshcase being included.

DataAnalysis:

Afterenrolling the patient for the study, a separate file for each patient will beopened and all forms will be kept in the file, study no. and patient identifyno. 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 will be made at the assessment form orother suitable forms. The data recordings will be monitored by Head of the Departmentand Pharmaco – vigilance committee. All forms will be further scrutinized in thepresence of investigators with concerned department faculty members for logicalerrors, incompleteness of data, and manipulation of results to avoid any bias.