| CTRI Number |
CTRI/2025/08/093558 [Registered on: 25/08/2025] Trial Registered Prospectively |
| Last Modified On: |
26/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homeopathic medicines for adult patients with mild hypothyroidism, fatigue, weight gain, constipation, dry skin, and cold intolerance. |
|
Scientific Title of Study
|
A double-blind, randomized, placebo-controlled trial of individualized homoeopathic medicines in the treatment of subclinical hypothyroidism in adults |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1327-1865 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sagar Saha |
| Designation |
Postgraduate Trainee |
| Affiliation |
D N De Homoeopathic Medical College and Hospital |
| Address |
12, Gobinda Khatick Road, Kolkata, WEST BENGAL 700046
Kolkata
WEST BENGAL
700046
India |
| Phone |
8900433766 |
| Fax |
|
| Email |
Sagars.kvcob05@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sagar Saha |
| Designation |
Postgraduate Trainee |
| Affiliation |
D N De Homoeopathic Medical College and Hospital |
| Address |
12, Gobinda Khatick Road, Kolkata, WEST BENGAL 700046
WEST BENGAL
700046
India |
| Phone |
8900433766 |
| Fax |
|
| Email |
Sagars.kvcob05@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mohan Giri |
| Designation |
Professor and Head, Depertment of Practice of Medicine |
| Affiliation |
D N De Homoeopathic Medical College and Hospital |
| Address |
12, Gobinda Khatick Road, Kolkata, WEST BENGAL 700046
Kolkata
WEST BENGAL
700046
India |
| Phone |
9433904265 |
| Fax |
|
| Email |
giri.drmohan@gmail.com |
|
|
Source of Monetary or Material Support
|
| D N De Homoeopathic Medical College and Hospital, Govt. of West Bengal, 12,
Gobinda Khatick Road, Kolkata 700046, West Bengal |
|
|
Primary Sponsor
|
| Name |
D. N. De Homoeopathic Medical College and Hospital |
| Address |
12, Gobinda Khatick Road, Kolkata, WEST BENGAL 700046 |
| Type of Sponsor |
Government 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 Sagar Saha |
D N De Homoeopathic Medical College and Hospital |
Dept. of Practice of Medicine OPD 1 and PG 5 OPD, 12, Gobinda Khatick Road, Kolkata, WEST BENGAL 700046
Kolkata
WEST BENGAL |
8900433766
Sagars.kvcob05@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of D N De Homoeopathic Medical College & Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E03||Other hypothyroidism, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Identical
looking
placebo plus
concomitant
care |
This arm will receive a placebo. The placebo is identical in appearance to the verum. Each dose of placebo will consist of 3-4 globules (no. 30) of cane sugar, moistened with rectified spirit, to be taken orally on a clean tongue with an empty stomach; dosage and repetition depend upon the individual requirement of the cases.
Concomitant care: Every subject is advised adequate rest and balanced diet, to avoid goitrogenic food substances like soya bean, selenium, iron etc. Physical activity and exerciseare encouraged and the subjects were advised to be present for monthly follow-ups.
Duration of therapy: 3 months.
|
| Intervention |
Individualized homeopathic medicines plus concomitant care |
Intervention is planned as administering indicated homoeopathic medicines in centesimal potencies (CH). Each dose will consist of 3-4 globules (no. 30) of cane sugar, moistened with the indicated medicine (preserved in 90% v/v ethanol), to be taken orally on a clean tongue in an empty stomach; dosage and repetition depending upon the individual requirement of the cases. Patients will be advised to refrain from handling the globules or from eating, drinking, smoking or brushing their teeth within 30 minutes of taking the globules and will be asked to suck the globules rather than simply swallowing those. Single individualized medicine will be prescribed on each occasion considering presenting symptom totality, clinical history details, constitutional features, miasmatic expressions, repertorization using HOMPATH/RADAR software when required with due consultation of Materia Medica and due consensus among three homoeopaths. All the medicines and sundry items will be procured from a Good Manufacturing Practice (GMP) certified firm.
Concomitant care:
Every subject is advised adequate rest and balanced diet, to avoid goitrogenic food substances like soya bean, selenium, iron etc. Physical activity and exercise are encouraged and the subjects were advised to be present for monthly follow-ups. Duration of therapy: 3 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients suffering from newly diagnosed subclinical hypothyroidism [ICD 11- 5A00.Z]
2. Serum TSH between 4.5 to 10 mIU/L, with normal T4 levels confirmed with biochemical investigation.
3. Age between 18 and 65 years
4. Patients of either sex, transgender.
|
|
| ExclusionCriteria |
| Details |
1. Not providing written informed consent for participation.
2. Diagnosed clinical cases of hypothyroidism
3. Vulnerable population—unconscious, ambulatory, too sick for consultation, disabled, terminally ill or critically ill patients; institutionalized subjects, mentally incompetent people
4. Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life or any organ failure.
5. Pregnant and puerperal women, lactating mothers
6. Patient under tobacco chewing and/or smoking, alcoholism and/or any other form(s) of substance abuse and/or dependence.
7. Self-reported immune-compromised state
8. Already undergoing homoeopathic treatment for chronic disease within last 6 months.
9. Simultaneous participation in any other clinical trials. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Serum TSH level |
At baseline and after 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Blood T3 and T4 levels |
At baseline and after 3 months |
| Thyroid-related quality of life (ThyPRO) questionnaire |
At baseline, monthly, up to 3
months |
| Zuleswki’s clinical score (ZCS) for hypothyroidism |
At baseline, monthly, up to 3
months |
| Measure Yourself Medical Outcome Profile version 2.0 (MYMOP-2) |
At baseline, monthly, up to 3
months |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
05/09/2025 |
| 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="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [Sagars.kvcob05@gmail.com].
- For how long will this data be available start date provided 01-01-2028 and end date provided 31-12-2032?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Subclinical hypothyroidism (ICD 11-5A00.Z), characterized by elevated thyroid-stimulating hormone (TSH) levels
alongside normal free thyroxine (T4) concentrations, poses a notable challenge
in endocrine disorders. Prevalence estimates indicate that approximately 4% of
adults in Western countries have overt hypothyroidism, with a significant rise
to around 15% when including subclinical hypothyroidism. According to the
epidemiological study that was conducted in eight cities in India, its
prevalence is about 10.95%, out of which Kolkata recorded the highest number of cases [5]. In the study, 8.02% of individuals were diagnosed withsubclinical hypothyroidism [5]. Patients with subclinical hypothyroidism might exhibit
symptoms similar to those observed in overt hypothyroidism. However, these
symptoms are often nonspecific and may include fatigue, weight gain,
constipation, dry skin, and mild cognitive impairment. The nuanced clinical
picture of subclinical hypothyroidism—where the decision to treat hinges on a comprehensive
assessment of age, risk factors, and comorbid conditions—underscores the need
for individualized approaches. Previously, few clinical trials have been done
in homoeopathy, most of which have shown promising results in lowering blood
TSH levels through homeopathic intervention in the treatment of
hypothyroidism.
Previously, exploratory and open-label single-arm trials were conducted. However, further studies are needed to
confirm the efficacy of IHMs in hypothyroid adults. This trial is merely
another attempt to detect and prove the efficacy of IHMs in reducing blood TSH
levels by a 2:1 randomized ratio in 110 participants with prediabetes at the
OPD of D.N. De Homoeopathic Medical College and Hospital. Assessment will be
done by estimating the blood TSH, T3, and T4 levels; ZCS; and ThyPRO39, and the MYMOP2 questionnaire (secondary) will be measured monthly for up to 3 months. A
comparative analysis will be conducted to detect group differences. |