| CTRI Number |
CTRI/2025/09/094685 [Registered on: 12/09/2025] Trial Registered Prospectively |
| Last Modified On: |
09/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Efficacy of homoeopathic medicine in treatment of hypothyroidism |
|
Scientific Title of Study
|
Efficacy of Homoeopathic Medicine Thyroidinum 3X in Treatment of Hypothyroidism among 18-65 years aged assessing Thyroid Function Test: A Double-Blind, Randomized, Placebo-Control Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1321-8107 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Debarsi Das |
| Designation |
Professor and HOD, Department of Organon of Medicine |
| Affiliation |
Metropolitan Homoeopathic Medical College and Hospital |
| Address |
Out-patient Department (Room No. 3), Emergency Out-patient Department (Room No.13) and In-patient Departments (Room IPD-M, IPD-F), Hospital Division Ramchandrapur, Sodepur
North Twentyfour Parganas
WEST BENGAL
700110
India |
| Phone |
8240821020 |
| Fax |
|
| Email |
drdebarsi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Avidipta Hazra |
| Designation |
Scholar |
| Affiliation |
Metropolitan Homoeopathic Medical College and Hospital |
| Address |
Out-patient Department (Room No. 3), Emergency Out-patient Department (Room No.13) and In-patient Departments (Room IPD-M, IPD-F), Hospital Division Ramchandrapur, Sodepur
North Twentyfour Parganas
WEST BENGAL
700110
India |
| Phone |
6295628901 |
| Fax |
|
| Email |
avidipta.kurchi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Avidipta Hazra |
| Designation |
Scholar |
| Affiliation |
Metropolitan Homoeopathic Medical College and Hospital |
| Address |
Out-patient Department (Room No. 3), Emergency Out-patient Department (Room No.13) and In-patient Departments (Room IPD-M, IPD-F), Hospital Division Ramchandrapur, Sodepur
North Twentyfour Parganas
WEST BENGAL
700110
India |
| Phone |
6295628901 |
| Fax |
|
| Email |
avidipta.kurchi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Metropolitan Homoeopathic Medical College and Hospital Sodepur, Kolkata, West Bengal, India, 700110 |
|
|
Primary Sponsor
|
| Name |
Metropolitan Homoeopathic Medical College and Hospital |
| Address |
Ramchandrapur, Sodepur, North Twentyfour Parganas, Kolkata, 700110 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Debarsi Das |
Metropolitan Homoeopathic Medical College and Hospital |
Out-patient Department (Room No. 3), Emergency Out-patient Department (Room No.13) and In-patient Departments (Room IPD-M, IPD-F), Hospital Division Ramchandrapur, Sodepur
North Twentyfour Parganas
WEST BENGAL |
8240821020
drdebarsi@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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Hypothyroidism |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
Identical-looking placebo (in size, colour, smell, taste etc.), 100 mg tablet, orally, once daily with general management.Tablet will be taken minimum after thiry minutes of food intake. All tablet will be procured from a Good Manufacturing Practice (GMP)-certified company. Duration of Intervention per participant: 3 months |
| Intervention |
Thyroidinum 3X |
Homoeopathic medicine Thyroidinum 3X, 100 mg tablet (content approximately calculated 0.1 mg of sarcode essence on each 100 mg tablet), orally, once daily with general management. Tablet will be taken minimum after thiry minutes of food intake. All Tablets will be procured from a Good Manufacturing Practice (GMP)-certified company.
Duration of Intervention per participant: 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient having Zulewski clinical score more than 3 points.
2. Patients having serum TSH levels (more than 4.5 to lesser equal to 12 µIU/ml).
3. Patients of age between 18 and 65 years.
4. Patients of either sex or transgender.
5. Patients may have symptoms of homoeopathic medicine Thyroidinum.
6. Literate patients willing to take part in the study and ready to give written consent for the same. |
|
| ExclusionCriteria |
| Details |
1. Zulewski clinical score lesser than 3 points.
2. Patients having serum TSH level greater than 12 µIU/ml.
3. Patients under-going any treatment for thyroid dysfunction.
4. Illiterate patients and/or patients not giving written informed assent and/or consent to participate.
5. Vulnerable population–unconscious, non-ambulatory, too sick for consultation, terminally or critically ill patients, mentally incompetent people.
6. Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life threatening illness led to any organ failure.
7. Pregnant, Lactating mother, Substance abuse and/or dependence.
8. Self-reported immune-compromised state.
9. Undergoing homoeopathic treatment for any chronic disease. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Thyroid Stimulating Hormone |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Free T4 |
3 months |
| Zulewski Clinical Score |
3 months |
| Thyroid Symptoms Questionnaire-TSQ |
3 months |
| Thyroid-specific Patient Reported Outcome-ThyPRO |
3 months |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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)
|
30/11/2025 |
| 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="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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- 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.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [avidipta.kurchi@gmail.com].
- For how long will this data be available start date provided 31-10-2026 and end date provided 31-10-2027?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Hypothyroidism is characterized by a wide spectrum of severity, ranging from the overt form marked by myxoedema, significant endorgan involvement and multisystem compromise, to asymptomatic subclinical presentation. It clinically manifested with fatigue and muscle weakness, alongside dry, coarse skin and sensitivity to cold, hair thinning, difficulty concentrating with memory lapses, constipation, unexplained weight gain despite a poor appetite, and menstrual disturbances. Thyroid disorders rank as the most prevalent endocrine condition both in India and across the globe. ICD10 code for hypothyroidism diagnosis is E03.9, and 5A00.Z for latest ICD11. Kolkata leads Indian cities with a hypothyroidism prevalence of 21.6 percentage, while other urban cities report rates between 8.8 percentage in Hyderabad and 11.07 percentage in Delhi. Untreated hypothyroidism can result in serious cardiovascular and neurological complications. Homoeopathic medicine, Thyroidinum is a sarcode, prepared form of sheep or calf thyroid gland, used for treating various thyroid imbalances. This randomized, double blind, placebo controlled trial is designed to evaluate the efficacy of homeopathic Thyroidinum 3X in adults with hypothyroidism and fulfil the existing research gap. |