STUDY ENROLMENT

In this study, patients reporting at the OPD with the clinical symptoms of  patchy loss of skin colour. Premature whitening or graying of the hair on scalp, eye lashes, eye brows or beard. loss of colour in the tissues that lines inside the mouth,nose.  Patient will be examined clinically for enrolling in the study based on inclusion and exclusion criteria.The patients who are to be enrolled patients 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 and to their informants.  After ascertaining the parent’s willingness, informed consent would be obtained in writing from them in the consent form (Form IV-A).  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, complications 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 I-A, Form II and Form III will be used for recording the patient’s history, clinical examination of symptoms, signs and laboratory investigations respectively. Patients would be advised to take the trial drug and appropriate dietary advice (Form IV-D) would be given according to the patient’s perfect understanding.