Study Enrollment:

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

            The patients 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 be obtained in writing from them.

All these patients will be given unique registration card in which patient’s registration number of the study, address, phone number and doctors 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 history proforma and clinical assessments forms separately.

Laboratory investigations are done periodically and are reported in the respective form. Patients would be advised to take the trial drug and appropriate dietary advice would be given according to the patient’s perfect understanding.

Conduct of the study:

            On the first day of the treatment, purgation (vellai ennai 15ml) will be given early morning for balancing the deranged thathus. From the next day, the trial drug KOTTAI KARANTHAI CHOORANAM (Internal (4grams) – twice/day), SEMPARUTHI POO ENNAI (External) is given continuously for 40 days. OPD Patients should visit the hospital once in 5 days. At each clinical visit, clinical assessment is done and prognosis is noted. The In Patient Department (IPD) patients are provided with Internal and External medication along with Yoga therapy and prognosis is noted. Clinical assessment is noted daily.  Laboratory investigations are done on 0^th day, 20^th day, and 40th day of the trial. IPD patients, who are not in a situation to stay 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 for another 2 months for further follow-up. If any trial patient who fails to collect the trial drug on the prescribed day but wants to continue in the trial form the next day, he/she will be allowed, but defaulters of one week and more will not be allowed to continue and be withdrawn from the study with a fresh case being included.

Data Analysis:

            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 identify 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 forms. The data recordings will be monitored by Head of the Department and Pharmaco – vigilance committee. All forms will be further scrutinized in the presence of investigators with concerned department faculty members for logical errors, incompleteness of data, and manipulation of results to avoid any bias.