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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 

 
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