| CTRI Number |
CTRI/2024/06/069397 [Registered on: 24/06/2024] Trial Registered Prospectively |
| Last Modified On: |
20/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to assess the role of Homoeopathic medicine Syphilinum in treating
OCD. |
|
Scientific Title of Study
|
A Prospective Study on the Effectiveness of Syphilinum in Obsessive Compulsive Disorder assessed using 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 APARNA P R |
| Designation |
PG Scholar |
| Affiliation |
Sarada Krishna Homoeopathic Medical College |
| Address |
4th floor,Department of Psychiatry, Sarada Krishna Homoeopathic Medical College, Kulasekharam, Kanniyakumari district
Kanniyakumari TAMIL NADU 629161 India |
| Phone |
8089642715 |
| Fax |
|
| Email |
draparnapr@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr MANU MANJITH S |
| Designation |
Assistant Professor |
| Affiliation |
Sarada Krishna Homoeopathic Medical College |
| Address |
4th floor, Department of Psychiatry, Sarada Krishna Homoeopathic Medical College, Kulasekharam, Kanniyakumari district
Kanniyakumari TAMIL NADU 629161 India |
| Phone |
9447755193 |
| Fax |
|
| Email |
manjithsura@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr MANU MANJITH S |
| Designation |
Assistant Professor |
| Affiliation |
Sarada Krishna Homoeopathic Medical College |
| Address |
4th floor, Department of Psychiatry, Sarada Krishna Homoeopathic Medical College, Kulasekharam, Kanniyakumari district
Kanniyakumari TAMIL NADU 629161 India |
| Phone |
9447755193 |
| Fax |
|
| Email |
manjithsura@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institution - Sarada Krishna Homoeopathic Medical College, Kulasekharam, Kanniyakumari district, Tamil Nadu,India. Pin:-629161 |
|
|
Primary Sponsor
|
| Name |
Post Graduate research funded by College |
| Address |
Sarada Krishna Homoeopathic Medical College, Kulasekharam, Kanniyakumari district, Tamil Nadu ,India. Pin :-629161 |
| Type of Sponsor |
Private medical college |
|
|
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 APARNA P R |
SARADA KRISHNA HOMOEOPATHIC MEDICAL COLLEGE |
Sarada Krishna Homoeopathic Medical College, Kulasekharam, Kanniyakumari district.
Room no :-510
Department of Psychiatry Kanniyakumari TAMIL NADU |
8089642715
draparnapr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITEE SARADA KRISHNA HOMOEOPATHIC MEDICAL COLLEGE |
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 |
| Comparator Agent |
NIL |
NIL |
| Intervention |
SYPHILINUM |
Syphilinum will be prescribed based on Symptom similarity.
Potency of the medicine will be based on Homoeopathic Principles . Follow up will be done in every month for a period of 6 months.
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
64.00 Year(s) |
| Gender |
Both |
| Details |
Patients of age group between 19-64 years.
Patients of both genders will be included.
Cases meeting the diagnostic criteria of OCD based on ICD-11.
|
|
| ExclusionCriteria |
| Details |
Patients above 65 years is excluded.
Patients receiving any other form of Psychotherapy or treatment procedures.
Patients who are having other Psychiatric comorbidity are excluded.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The effectiveness of Homoeopathic Medicine Syphilinum will be assessed based on the improvement of the Yale Brown Obsessive compulsive scale score of the patient suffering with OCD. |
6 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="15" Sample Size from India="15"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/07/2024 |
| 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="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
For people with Obsessive
Compulsive Disorder (OCD), thoughts are persistent and intrusive, and behaviours
are rigid. Not performing the behaviours commonly causes great distress, often
attached to a specific fear of dire consequences (to self or loved ones) if the
behaviours are not completed. The greatest agony of the individuals suffering
with OCD is the perceived irrationality of the symptoms on one hand and the
unsurpassable desire to yield to these symptoms on the other. Homoeopathy
offers a holistic approach to healthcare, considering the mental, emotional and
physical aspects of a person. OCD involves both psychological and physical
symptoms, making it a relevant subject for exploration within the context of
Homoeopathic treatment, as much researches has not been conducted in
Homoeopathy regarding Obsessive compulsive disorder. There is also a lack of
studies connecting Homoeopathic medicine Syphilinum with OCD.
People suffering
from obsessive compulsive disorder should be assessed using Yale Brown Obsessive
Compulsive Scale. Based on the
assessment Symptom similarity of patient will be compared with Syphilinum and
medicine will be given . During the course of treatment improvement will be
assessed using Yale Brown Obsessive Compulsive Scale.
The effectiveness
of Homoeopathic Medicine Syphilinum will be assessed based on the improvement
of the Y-BOCS scale score of the patient suffering with OCD. A regular follow
up will be done for a minimum period of
6 months.
|