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CTRI Number  CTRI/2025/03/081693 [Registered on: 05/03/2025] Trial Registered Prospectively
Last Modified On: 30/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Use Of Homoeopathy In Hypothyroidism 
Scientific Title of Study   Role Of Individualized Homoeopathic Medicines In The Treatment Of Subclinical Hypothyroidism Using Synthesis Repertory An Open Label Prospective Clinical Study  
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 Vaka Ashok Kumar 
Designation  PGT Trainee 
Affiliation  National Institute Of Homoeopathy 
Address  OPD Room No 10, Department Of Case Taking And Repertory, National Institute of Homoeopathy, Block GE, Sector III, Salt Lake, Kolkata West Bengal 700106 India

Kolkata
WEST BENGAL
700106
India 
Phone  7981927933  
Fax    
Email  ashokkumarvaka24@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Avijit Shee Burman 
Designation  Professor 
Affiliation  National Institute Of Homoeopathy 
Address  OPD Room No 10, Department Of Case Taking And Repertory, National Institute of Homoeopathy, Block GE, Sector III, Salt Lake, Kolkata West Bengal 700106 India

Kolkata
WEST BENGAL
700106
India 
Phone  9433392108  
Fax    
Email  asheeburman@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Avijit Shee Burman 
Designation  Professor 
Affiliation  National Institute Of Homoeopathy 
Address  OPD Room No 10, Department Of Case Taking And Repertory, National Institute of Homoeopathy, Block GE, Sector III, Salt Lake, Kolkata West Bengal 700106 India


WEST BENGAL
700106
India 
Phone  9433392108  
Fax    
Email  asheeburman@gmail.com  
 
Source of Monetary or Material Support  
National Institute Of Homoeopathy, Block GE, Sector III, Salt Lake, Kolkata, West Bengal,700106, India. 
 
Primary Sponsor  
Name  National Institute Of Homoeopathy 
Address  National Institute Of Homoeopathy, Block GE, Sector III, Salt Lake, Kolkata, West Bengal,700106, India. 
Type of Sponsor  Government 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 Vaka Ashok Kumar  National Institute of Homoeopathy  OPD No 10, Department Of Case taking And Repertory, Block GE, Sector III, Salt Lake
Kolkata
WEST BENGAL 		 7981927933

ashokkumarvaka24@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
National Institute Of Homoeopathy  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E039||Hypothyroidism, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Individualized Homoeopathic Medicine  Indicated individualized homoeopathic medicines will be prescribed after the repertorisation of the case using rubrics within synthesis repertory. Dose and frequency of the selected medicine will be as per the susceptibility of the case. Follow up will be done monthly till 6 months from the baseline. 
Comparator Agent  Not applicable  Not applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients of both sexes from any religion or socio-demographic background and aged between 18-65 years with high Serum TSH level but less than 20 mIU/ml (5-20 mIU/ml), and T3, T4 within normal range.
2. Patients agreeing to undergo T3, T4, TSH investigation, if required.
3. Patients willing to give written consent to participate in the study.
 
 
ExclusionCriteria 
Details  1. Patients with serum TSH level more than 20 mIU/ml.
2. Pregnant or lactating women.
3. Patients taking any other treatment for subclinical hypothyroidism from other system of medicine.
4. Patients having the habits of substance abuse and/or dependence.
5. Patients having any uncontrolled systemic illness or any life-threatening disease.
6. Patients not willing to participate in the study, not willing to undergo any investigation, if so advised.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess Serum TSH Level & Thyroid Symptom Rating Questionnaire (Thy-SRQ)  Baseline & 6 months
 
 
Secondary Outcome  
Outcome  TimePoints 
Socio-demographic data  After 6 months 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   18/03/2025 
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="1"
Months="6"
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   Subclinical Hypothyroidism is a clinical condition in which serum TSH is raised, and serum T3 and T4 concentrations are at the lower end of the reference range.

 1. Samples will be selected following preliminary and detailed screening using specified selection criteria. 
 2. Inclusion and exclusion criteria are strictly followed. 
 3. After consideration of dropout cases, a minimum 40 patients will be enrolled for the study. 
 4. Case-taking will be done as per the strict homoeopathic principle.
 5. Baseline scoring will be taken using Thy-SRQ & and Serum TSH levels will be assessed. 
 6. Analysis and evaluation of each case will be done. 
 7. Miasmatic analysis will be done. 
 8. Repertorization will be done in Synthesis Repertory. 
 9. Final selection of the remedy will be done after consultation with Materia Medica. 
 10. Potency, dose and repetition of the indicated remedies will be guided strictly as per homoeopathic principles. 
 11. General (non-medicinal) management including appropriate diet and regimen will be advised. 
 12. Subsequent prescriptions (follow-ups) will be generated according to relevant homoeopathic principles and will be recorded in follow-up sheets. 
 13. The baseline data will be compared with the data obtained after 6 months. 
 14. The score obtained by the patients will be compared and result will be analyzed as per appropriate statistical methods and interference will be done thereafter.
 
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