| CTRI Number |
CTRI/2025/01/079771 [Registered on: 29/01/2025] Trial Registered Prospectively |
| Last Modified On: |
20/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of homoeopathic medicine in cases of obsessive compulsive disorder |
|
Scientific Title of Study
|
Role of homoeopathic constitutional medicines in cases of obsessive compulsive disorder (dsm -5 ) assessed by yale brown obsessive compulsive scale |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR MAUNIL DILIPKUMAR PATEL |
| Designation |
PG SCHOLAR |
| Affiliation |
SMT A J SAVLA HOMOEOPATHIC MEDICAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
DEPARTMENT OF MEDICINE ROOM NO 06 GROUND FLOOR SMT A J SAVLA HOMOEOPATHIC MEDICAL COLLEGE AND RESEARCH INSTITUTE PUSHPANJALI BUILDING NEAR DISTRICT SESSION COURT MEHSANA
Mahesana
GUJARAT
384001
India |
| Phone |
9773413619 |
| Fax |
|
| Email |
maunil05@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR NISHA TRIVEDI |
| Designation |
HOD AND PROFESSOR DEPARTMENT OF HOMOEOPATHIC MATERIA MEDICA |
| Affiliation |
SMT A J SAVLA HOMOEOPATHIC MEDICAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
DEPARTMENT OF HOMOEOPATHIC MATERIA MEDICA FIRST FLOOR ROOM NO 15 SMT A J SAVLA HOMOEOPATHIC MEDICAL COLLEGE AND RESEARCH INSTITUTE PUSHPANJALI BUILDING NEAR DISTRICT SESSION COURT MEHSANA
Mahesana
GUJARAT
384001
India |
| Phone |
9974342824 |
| Fax |
|
| Email |
nisha.mehul.26@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR MAUNIL DILIPKUMAR PATEL |
| Designation |
PG SCHOLAR |
| Affiliation |
SMT A J SAVLA HOMOEOPATHIC MEDICAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
DEPARTMENT OF MEDICINE ROOM NO 06 GROUND FLOOR SMT A J SAVLA HOMOEOPATHIC MEDICAL COLLEGE AND RESEARCH INSTITUTE PUSHPANJALI BUILDING NEAR DISTRICT SESSION COURT MEHSANA
Mahesana
GUJARAT
384001
India |
| Phone |
9773413619 |
| Fax |
|
| Email |
maunil05@gmail.com |
|
|
Source of Monetary or Material Support
|
| SMT A J SAVLA HOMOEOPATHIC MEDICAL COLLEGE AND RESEARCH INSTITUTE PUSHPANJALI BUILDING NEAR DISTRICT SESSION COURT MEHSANA GUJARAT 384001 |
|
|
Primary Sponsor
|
| Name |
DR MAUNIL D PATEL |
| Address |
DEPARTMENT OF MEDICINE ROOM NO 06 GROUND FLOOR SMT A J SAVLA HOMOEOPATHIC MEDICAL COLLEGE AND RESEARCH INSTITUTE PUSHPANJALI BUILDING NEAR DISTRICT SESSION COURT MEHSANA GUJARAT 384001 |
| Type of Sponsor |
Other [SELF] |
|
|
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 MAUNIL D PATEL |
SMT A J SAVLA HOMOEOPATHIC MEDICAL COLLEGE AND RESEARCH INSTITUTE |
PUSHPANJALI BUILDING NEAR DISTRICT SESSION COURT MEHSANA GUJARAT 384001
Mahesana
GUJARAT |
9773413619
maunil05@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMT A J SAVLA HOMOEOPATHIC MEDICAL COLLEGE AND RESEARCH INSTITUTE INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F429||Obsessive-compulsive disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
HOMOEOPATHIC CONSTITUTIONAL MEDICINES |
POTENCY AS PER NEED DECIMAL CENTICIMAL 50 MILLESIMAL ETC DOSE AS PER NEED REPETITION AS PER NEED FREQUENCY ROOT OF ADMINISTARTION ORAL DURATION OF THERAPY UPTO 12 MONTH AS PER NEED OF CASE |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Gender Men and women and transgender
Diagnosis Diagnosed through sign and symptoms describe in DSM 5 diagnostic and statistical manual of mental disorder 5
Score Cases ranging the score between 10 to 30 according to Ybocs scale
|
|
| ExclusionCriteria |
| Details |
Patient having certain co morbidities such as depression with suicidal tendencies uncontrolled diabetes renal disease like CKD cardiac anomalies like cardiomegaly uncontrolled hpertension neurological problems like complete paralysis coma etc
Patient having suicidal tendencies with OCD
Patient if taking any conventional mode of treatments such as anxiolytic antidepressant
Pregnant women
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| YALE BROWN OBSESSIVE COMPULSIVE SCALE TO ASSESS THE REDUCTION OF SEVERITY OF SYMPTOMS OF OCD |
SCORE WILL BE ASSESED AT BASELINE 6 MONTHS AND AT THE END OF TREATMENT 12 MONTH |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| SHEEHAN DISABILITY SCALE TO ASSESS IMPROVEMENT IN QUALITY OF LIFE |
SCORE WILL BE ASSESSED AT BASELINE 6 MONTH AND AT THE END OF TREATMENT 12 MONTH |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
10/02/2025 |
| Date of Study Completion (India) |
10/07/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
10/07/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
IS A PROSPECTIVE STUDY PRE TEST POST TEST ONE GROUP EXPERIMENTAL STUDY TO
ASSESS THE ROLE OF HOMOEOPATHIC CONSTITUTIONAL MEDICINE FOR 12 MONTH IN 30 PARTICIPANTS WITH
OBSESSIVE COMPULSIVE DISORDER THAT WILL BE CONDUCTED AS PER INCLUSION AND
EXCLUSION CRITERIA FROM OUTPATIENT DEPARTMENT AND THE PRIMARY OUTCOME MEASURE WILL
ASSESS THE REDUCTION OF SEVERITY OF SYMPTOMS OF THE PARTICIPANTS USING YALE BROWN OBSESSIVE COMPULSIVE SCALE AND SECONDARY OUT COME WILL BE ASSESED WITH SHEEHAN DISABILITY SCALE BOTH SCORE WILL BE ASSESED AT BASELINE 6 MONTH AND AT THE END OF TREATMENT 12 MONTH FOLLOW UP AS
PER NEED OF CASE FOR 12 MONTH OF DURATION |