| CTRI Number |
CTRI/2025/07/091167 [Registered on: 18/07/2025] Trial Registered Prospectively |
| Last Modified On: |
18/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homoeopathy for Obsessive Compulsive Disorder (OCD) |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 1.6 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Deepthi Gilla |
| Designation |
Research officer (H)/Scientist-2 |
| Affiliation |
Regional Research Institute (Homoeopathy) |
| Address |
Room no-9, Clinical Research Division, Regional Research Institute (Homoeopathy), Street no.4, Habsiguda, Hyderabad, Telangana state.
Hyderabad TELANGANA 500012 India |
| Phone |
8111990221 |
| Fax |
|
| Email |
drdeepthigilla@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Deepthi Gilla |
| Designation |
Research officer (H)/Scientist-2 |
| Affiliation |
Regional Research Institute (Homoeopathy) |
| Address |
Room no-9, Clinical Research Division, Regional Research Institute (Homoeopathy), Street no.4, Hyderabad, Telangana state.
Hyderabad TELANGANA 500012 India |
| Phone |
8111990221 |
| Fax |
|
| Email |
drdeepthigilla@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Dhanraj Kumar Rana |
| Designation |
Research officer (H)/Scientist-2 |
| Affiliation |
National Homoeopathy Research Institute in Mental Health |
| Address |
Room no-106, Department of Psychiatry, Clinical Research Division, National Homoeopathy Research Institute in Mental Health, Kottayam, Kerala
Kottayam KERALA 686532 India |
| Phone |
9496470061 |
| Fax |
|
| Email |
drdkrana123@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Homoeopathy, under Ministry of AYUSH, Govt of India, Janakpuri, D-Block, New Delhi, India. 110058 |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Homoeopathy |
| Address |
61-65, Institutional Area, Opp. ‘D’ Block, Janak Puri, New Delhi – 110058, India. |
| Type of Sponsor |
Other [Research council under Govt. of India] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Dhanraj Kumar Rana |
National Homoepathy Research Institute in Mental Health, Kottayam |
Room no-106, Department of Psychiatry, Clinical Research Division, Kurichy, Sachivothamapuram, Kurichy, Kottayam Kottayam KERALA |
9496470061 04812432238 drdkrana123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NHRIMH IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F42||Obsessive-compulsive disorder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Identical Placebo |
4 pills of 30 size unmedicated globules |
| Intervention |
Individualized Homoeopathic Medicines (IHM) |
A dose of IHM shall be 4 pills of 30 size |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Cases fulfilling ICD-11 Criteria for OCD (6B20) |
|
| ExclusionCriteria |
| Details |
1. Patients with Schizophrenia, Depression and Bipolar mood disorder or any other psychiatric co-morbidity who exhibit Obsessive symptoms.
2. cases who are under psychotropic medicines for the past one month
3. cases with below-average IQ / educational status below SSC
4. Who are not able or not willing to consent.
5. Pregnant and lactating women.
6. Patients with concurrent life-threatening diseases.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| More than 50% reduction in symptom score in comparison to baseline as per Y-BOCS at the exit of treatment of 1 year. |
3,6,9,12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| More than 50% reduction in symptom score in comparison to baseline as per DOCS at the exit of treatment of 1 year. |
Baseline, 3,6,9,12 months |
|
|
Target Sample Size
|
Total Sample Size="66" Sample Size from India="66"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
16/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2" Months="3" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
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. |