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CTRI Number  CTRI/2025/08/093364 [Registered on: 20/08/2025] Trial Registered Prospectively
Last Modified On: 20/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Role of Homoeopathic Medicines in the treatment of Sub-Clinical Hypothyroidism  
Scientific Title of Study   Evaluating The Effectiveness Of Individualized Homoeopathic Medicines VS Thyroidinum 3X In Treatment Of Sub-Clinical Hypothyroidism: An Open Label Randomized Control Clinical Trial 
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 Honey 
Designation  PG Scholar 
Affiliation  Dr B R Sur Homoeopathic Medical College,Hospital And Research Centre 
Address  Department Of Practice Of Medicine Dr B R Sur Homoeopathic Medical College, Hospital And Research Centre, Nanakpura, Moti Bagh

South West
DELHI
110021
India 
Phone  9811136201  
Fax    
Email  mrhoney98@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Archana Narang 
Designation  Professor Of Department Of Practice Of Medicine  
Affiliation  Dr B R Sur Homoeopathic Medical College,Hospital And Research Centre 
Address  Department Of Practice Of Medicine Dr B R Sur Homoeopathic Medical College, Hospital And Research Centre, Nanakpura, Moti Bagh

South West
DELHI
110021
India 
Phone  9871347553  
Fax    
Email  shmc.thyroidclinic@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Honey 
Designation  PG Scholar 
Affiliation  Dr B R Sur Homoeopathic Medical College,Hospital And Research Centre 
Address  Department Of Practice Of Medicine Dr B R Sur Homoeopathic Medical College, Hospital And Research Centre, Nanakpura, Moti Bagh

South West
DELHI
110021
India 
Phone  9811136201  
Fax    
Email  mrhoney98@gmail.com  
 
Source of Monetary or Material Support  
Dr B R Sur Homoeopathic Medical College, Hospital And Research Centre, Nanakpura, Moti Bagh, New Delhi 110021 
 
Primary Sponsor  
Name  Dr Honey 
Address  Dr B R Sur Homoeopathic Medical College, Hospital And Research Centre, Nanakpura, Moti Bagh, New Delhi 110021, India 
Type of Sponsor  Other [Self] 
 
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 Honey  Dr B R Sur Homoeopathic Medical College, Hospital And Research Centre  OPD and IPD, Dr B R Sur Homoeopathic Medical College, Hospital And Research Centre, Nanakpura, Moti Bagh, New Delhi 110021
South West
DELHI 		 9811136201

mrhoney98@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E03||Other hypothyroidism,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Individualized Homoeopathic Medicines  Individualized homoeopathic medicines will be administered in the centesimal potencies Selected according to homoeopathic principles. The doses and repetition of Medicines will be done as per the requirement of each individual case i.e If TSH is same or No improvement then In 1st follow up: Change the medicine. After improvement in 1st and Stand still in 2nd follow up then medicine given with higher potency. If Improvement less than 40% then Repeat the medicine in same potency. If Improvement more than 40% or TSH under normal range then Sac lac will be given for next 6 weeks. If TSH increases then Either refer or intention to treat as homeopathic medicines, but took in a count for analysis of the study. The route of administration of medicines will be oral, in globules form, Duration: 6 MONTHS 
Comparator Agent  Thyroidinum 3X   Thyroidinum 3X medicine will be given after proper case taking they were prescribed 2 tablets of thyroidinum 3x thrice a day,Route of Drug administration is oral. If TSH is same or No improvement then repeat the same dose. If Improvement less than 40% then repeat the same dose. If Improvement more than 40% or TSH under normal range then stop medication for 6 weeks. If TSH increases then Either refer or intention to treat as homeopathic medicines, but took in a count for analysis of the study. DURATION :6 MONTHS 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Both sexes of age group above 18 years and below 60 years
2. Patients with newly diagnosed sub clinical hypothyroidism (elevated TSH levels but T3 and T4 are within normal limit) with or without anti TPO antibody. 
 
ExclusionCriteria 
Details  1. Sub-clinical hypothyroidism patient’s sufferings from any life-threatening illness, mental illness
who are terminally ill, under immunosuppressive treatment or self-reported immune-compromised
state.
2. Patients of malignancy or too sick for consultation.
3. Patient on substance abuse. (Drugs/Alcohol/Smoking).
4. Females who are in pregnancy and lactating period. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Comparison of Effectiveness: The trial is expected to reveal individualized homoeopathic
medicines (GROUP A) yield a significant reduction in serum TSH levels. This outcome would support
the hypothesis that homoeopathic interventions may effectively in sub clinical hypothyroidism. 		 11 months 
 
Secondary Outcome  
Outcome  TimePoints 
It is expected that T3 and T4 levels will remain within their normal reference range and
Anti TPO antibody levels will also starts moving towards the normal reference range. 		 11 months 
This study expected to identify the most effective homoeopathic medicines for the management of
subclinical hypothyroidism. 		 11 months 
It is expected that there will be symptomatic improvement assess through modified naranjo
criteria along with general well-being, without any substantial medicinal adverse effects. 		 11 months 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 
Date of First Enrollment (India)   01/09/2025 
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="0"
Months="11"
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   This study evaluating the effectiveness of Individualized homoeopathic medicines and Thyroidinum 3X in treating the patients of Sub-Clinical Hypothyroidism.
aged 18-60 years. Patients will be randomly assigned through online software to receive either individualized
homoeopathic medicines or Thyroidinum 3X. The study
will measure the improvement by investigating biochemically using S.TSH levels. It is expected that there will be clinically symptomatic improvement assess through modified naranjo criteria along with general well-being, without any substantial medicinal adverse effects. The results will provide valuable insights into the effectiveness of homoeopathic approaches in treatment of Sub-Clinical Hypothyroidism.
 
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