Effectiveness of Individualized Homoeopathic Treatment as Adjunctive to Cognitive Behavioural Therapy in the management of Obsessive-Compulsive Disorder- A Pilot, Double-Blind, Randomized, Placebo-Controlled Trial

This study shall be a randomized placebo-controlled trial with 66 subjects of OCD, 33 cases in each arm. The cases will be screened in General Psychiatry OPD of the institute as per Verbal Screening Form, and will be referred to investigator for detailed screening for inclusion and exclusion criteria. Establishment of the diagnosis will be followed by going through the Patient’s Information Sheet by the patient and giving “Written Informed Consent” and enrollment of patient in study. The process of Homoeopathic treatment will be fully explained to the patient before starting treatment. Each case will be observed for a period of 1 year with regular follow up of every 1 month.   The cases will be studied as per the principles of Homoeopathy. The prescription will be done after reference to standard Materia Medica, from the selected medicines on repertorization. Selection of potency, dose and repetition will be as per principles of Posology.Follow-up of the patients would be conducted every 1 month. Baseline scoring through Y-BOCS II and DOCS and the necessary laboratory investigation will be done during enrolment, follow up visits whenever necessary. Patients will be recruited from state-wide and those coming to out patient department in the institute where the study has been assigned. The centre will evolve its own advocacy procedures for attracting research subjects (advertisements, media, camps, handouts etc.) if necessary. They will all follow the standard recruitment procedure**.** The procedure involves a two-stage screening prior to initiation of the consent procedure.The OPD doctors shall verbally screen the patients coming to the outpatient department (OPD) of the Institutes/Unit for OCD.       No details will be kept on the number of patients verbally screened by the OPD doctors. It is expected that the centre investigators will ask the OPD doctor to screen as many patients as possible. Subjects, who are of relevant signs & symptoms, will be sent to the investigating officer for detail screening. These patients shall be referred to the Investigator for a detailed screening.  A record will be maintained of the potentially eligible subjects coming for the detailed screening. Details of the records will be kept on the number of subjects screened by the investigator. If the patient fulfils the requirements as per the detailed screening by investigator the investigator shall make the patient understand in detailed way about the study with the help of patient information sheet and simultaneously informed written consent form shall be signed by the patient in front of the investigator.      If the subjects are not literate, a thumbprint may be substituted for signature, duly witnessed by somebody in addition to the person requesting consent. If the patient does not fulfil the criteria, then he/ she shall be treated in the general OPD.       Enrolment shall be done on first come first basis. This shall be followed by filling of case recording format by the investigator to come to an individual picture of the participant which is in norms with the homeopathic principles. Those who are potentially eligible for the study will then be subjected to Baseline assessment, which shall be done using assessment form. After Baseline assessment, the patient enrolled in the study will be assigned a research study number to form part of the unique identifier number of the subject. The case shall be repertorized for selection of medicine (repertorial chart shall be attached along with the case recording format). Diagnosed cases of OCD (fulfilling the inclusion criteria) will go for homoeopathic therapy as per guidelines in this protocol. Diagnosed patients will be prescribed a single dose of indicated homoeopathic remedy in appropriate potency, followed by a placebo for 4 weeks. The baseline investigation should include CBC, Thyroid profile and serotonin level. Patients who are no longer eligible for the study at the completion of Baseline evaluation will not be enrolled in the study and receive usual care as clinically indicated. All the data will be recorded. The study personnel will explain and demonstrate to the patient how to take the medicine at home at recruitment and at all subsequent follow-up visits.     Each participant shall be followed up every 30 days as per the assessment form. After the enrolment begins, the investigator shall send the photocopies/e-mail/fax of all the forms along with case record within 72 hrs to the concerned coordinator for verifying the contents, so that it can be verified and corrected if any. The Investigator shall have the free hand to enquire about the condition of participant as and when required through telephonic conversation and if necessary through home visits in case the patient does not appear for regular follow ups. It should be recorded in follow up sheet along with date and time of telephonic call/home visit to patient.  The Investigator shall furnish his contact number to all the patients so the same can contact him or her whenever necessary.  At the end of the last follow-up of the last enrolled study subject, the data thus collected shall be analyzed with appropriate statistical methods and compiled for publication of the study.