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CTRI Number  CTRI/2024/07/071456 [Registered on: 29/07/2024] Trial Registered Prospectively
Last Modified On: 23/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   A Clinical trial to study the effect of Synthesis Repertory in Hemorrhoids 
Scientific Title of Study   Management of Hemorrhoids by identifying similimum using Synthesis Repertory  
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 Gokul R 
Designation  PG Scholar 
Affiliation  Tamilnadu DR M G R Medical University Chennai 
Address  Dept of Repertory White Memorial Homoeopathic Medical College and Hospital Attoor Veeyanoor Post

Kanniyakumari
TAMIL NADU
629177
India 
Phone  6380263020  
Fax    
Email  drgoksnov18@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr R K Dominin Raj 
Designation  Professor 
Affiliation  White Memorial Homoeopathy Medical College & Hospital  
Address  Department of Repertory White Memorial Homoeopathic Medical College and Hospital Attoor Veeyanoor Post

Kanniyakumari
TAMIL NADU
629177
India 
Phone  9447654467  
Fax    
Email  drdomininrajrk@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Gokul R 
Designation  PG Scholar 
Affiliation  Tamilnadu Dr M G R Medical University Chennai 
Address  Dept of Repertory White Memorial Homoeopathic Medical College and Hospital Attoor Veeyanoor Post

Kanniyakumari
TAMIL NADU
629177
India 
Phone  6380263020  
Fax    
Email  drgoksnov18@gmail.com  
 
Source of Monetary or Material Support  
Dept of Repertory White Memorial Homoeopathic Medical College and Hospital Attoor-629177 Kanniyakumari Tamilnadu India 
 
Primary Sponsor  
Name  White Memorial Homoeo Medical College Hospital Department Of Case taking and Repertory 
Address  White Memorial Homoeo Medical College & Hospital Attoor Veeyanoor post Kanyakumari District Tamilnadu 629177 
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 Gokul R  White Memorial Homoeopathy Medical College& Hospital   Dept of Repertory opd unit ipd unit health camps and peripheral centers
Kanniyakumari
TAMIL NADU 		 6380263020

drgoksnov18@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
White Memorial Homoeo Medical College and Hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K928||Other specified diseases of the digestive system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Homeopathic medicine   Medicines will be administered through oral route 
Intervention  Homeopathic medicine  Total duration of intervention is 1 year 
Intervention  Homoeopathic medicine  Medicine will be administered in minimum doses 
Intervention  Homoeopathic medicine  Medicine will be repeated once in 15 days to 1 month 
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients suffering from Hemorrhoids on the basis of clinical history and findings.
Subjects of both sexes.
First three grades of Hemorrhoids  
 
ExclusionCriteria 
Details  Patient who needs surgical intervention
Patient with complications of hemorrhoids
ï‚· Below the age of 20 and above the age of 60 years.
Hemorrhoids which are symptomatic of some other symptoms like CA rectum, anal
fissure, anal abscess and pregnancy
Patient with 4th grade of hemorrhoids.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Pre and post assessment will be done by comparing Hemorrhoids Disease Severity Score   Will be followed up once in 15 days TO 1 month 
 
Secondary Outcome  
Outcome  TimePoints 
Identifying Similimum using Synthesis Repertory  Action of Medicines will be assessed once in 15 days TO 1 month  
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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 
Date of First Enrollment (India)   05/08/2024 
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="1"
Months="0"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drgoksnov18@gmail.com].

  6. For how long will this data be available start date provided 25-12-2025 and end date provided 25-12-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Minimum of 30 cases selected for purposive sampling
Cases will be taken in detail and recorded in White Memorial Homoeopathic medical College and hospital pre structured standardized Case record
Diagnosis will be done by clinical symptoms and urine routine examination 
Analyzed case will be Individualized and suitable homoeopathic medicines will be selected
Changes in the symptom will be noted
Hemorrhoids Symptom severity score will be assessed every 15 days once until symptomatic relief of the patient
 
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