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CTRI Number  CTRI/2026/01/100784 [Registered on: 09/01/2026] Trial Registered Prospectively
Last Modified On: 09/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Homoeopathic treatment for improving symptoms in adults with hypothyroidism. 
Scientific Title of Study   A pre–post interventional study to assess the effectiveness of individualized homoeopathic medicines in fifty millesimal potency in the management of hypothyroidism using Kent’s Repertory. 
Trial Acronym  HOM-LM-HYPO Study 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sonali Sipra Sutar 
Designation  Post graduate student 
Affiliation  Mahesh Bhattacharya Homoeopathic Medical College and Hospital 
Address  Department of repertory,room no 9,Mehesh Bhattacharya Homoeopathic Medical College and hospital,Dr.Bholanath Chakraborty sarani,Ichapur,Howrah,West bengal
NIL
Haora
WEST BENGAL
711104
India 
Phone  7504502059  
Fax    
Email  sonaliksutar123@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr.Samir Manna 
Designation  Professor 
Affiliation  Mahesh Bhattacharya Homoeopathic Medical College and Hospital 
Address  Department of Repertory, Room No. 9, Mehesh Bhattacharya Homoeopathic Medical College & Hospital, Dr. Bholanath Chakraborty Sarani, Ichapur, Howrah, West Bengal – 711104, India.
NIL
Haora
WEST BENGAL
711104
India 
Phone  7504502059  
Fax    
Email  samirmannab4u@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr.Samir Manna 
Designation  Professor 
Affiliation  Mahesh Bhattacharya Homoeopathic Medical College and Hospital 
Address  Department of Repertory, Room No. 9, Mehesh Bhattacharya Homoeopathic Medical College & Hospital, Dr. Bholanath Chakraborty Sarani, Ichapur, Howrah, West Bengal – 711104, India.
NIL
Haora
WEST BENGAL
711104
India 
Phone  7504502059  
Fax    
Email  samirmannab4u@gmail.com  
 
Source of Monetary or Material Support  
Mahesh Bhattacharya Homoeopathic Medical College and Hospital 
 
Primary Sponsor  
Name  Mehesh Bhattacharya Homoeopathic Medical College Hospital 
Address  Mehesh Bhattacharya Homoeopathic Medical College & Hospital, Dr. Bholanath Chakraborty Sarani, Ichapur, Howrah, West Bengal – 711104, 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 
Sonali Sipra Sutar  Mahesh Bhattacharya Homoeopathic Medical College and Hospital  Department of Repertory, Room No. 9, Mehesh Bhattacharya Homoeopathic Medical College & Hospital, Dr. Bholanath Chakraborty Sarani, Ichapur, Howrah, West Bengal – 711104, India.
Haora
WEST BENGAL 		 07504502059

sonaliksutar123@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E039||Hypothyroidism, unspecified, (2) ICD-10 Condition: E039||Hypothyroidism, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Individualized Homoeopathic Medicines in LM Potencies  Participants will receive individualized homoeopathic medicines selected on the basis of totality of symptoms and repertorization using Kent’s Repertory. Medicines will be prescribed in LM (50 millesimal) potencies as per standard Hahnemannian guidelines. The potency, dose, and repetition will be individualized for each patient. Follow-up will be done every 4 weeks with modification of remedy or potency as required. No comparator arm is used as the study follows a pre–post interventional single-arm design. 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Adult patients aged 18 to 65 years.

2.Diagnosed primary hypothyroidism with TSH greater than 4.5 mIU per L.

3.FT3 and FT4 may be normal or low, including both subclinical and overt hypothyroidism.

4.Willing to take individualized homoeopathic treatment for six months.

5.Able and willing to give informed consent and comply with study procedures. 
 
ExclusionCriteria 
Details  1. Patients undergoing homoeopathic treatment for chronic diseases within the last 4 Weeks.
2.Patients with Secondary or Tertiary Hypothyroidism.
3. Diagnosed cases of uncontrolled systemic diseases or life-threatening illnesses affecting the quality of life of any organ failure.
4. Patients with psychiatric disorders.
5. Pregnant women, lactating women.
6. Patient those who are already taking anti-hypothyroid drugs. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.TSH– pre and post (biochemical assessment)
2.Zulewski score – before and after intervention  		 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
WHOQOL-BREF (World Health Organization Quality of Life – BREF version)   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   N/A 
Date of First Enrollment (India)   30/01/2026 
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 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 - YES
  1. What data in particular will be shared?
    Response (Others) -  NIL

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response (Others) -  NIL
  3. Who will be able to view these files?
    Response (Others) -  NIL

  4. For what types of analyses will this data be available?
    Response (Others) -  NIL

  5. By what mechanism will data be made available?
    Response (Others) -  NIL

  6. For how long will this data be available start date provided 01-01-2028 and end date provided 01-01-2033?
    Response (Others) -  NIL

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

This study is a pre–post interventional trial designed to evaluate the effectiveness of individualized homoeopathic medicines in fifty millesimal potency for the management of hypothyroidism. Adult patients diagnosed with primary hypothyroidism will receive individualized homoeopathic treatment based on Kent’s Repertory for a period of six months. The primary outcomes include change in thyroid stimulating hormone (TSH) levels and improvement in the Zulewski clinical hypothyroid score before and after the intervention. The secondary outcome includes improvement in quality of life as assessed by the WHOQOL-BREF questionnaire. The study hypothesizes that individualized homoeopathic LM potencies can produce clinically significant improvement in biochemical parameters, symptom scores and overall quality of life in patients with hypothyroidism.

 
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