| CTRI Number |
CTRI/2021/03/031671 [Registered on: 02/03/2021] Trial Registered Prospectively |
| Last Modified On: |
02/03/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homeopathy for thyroid problems |
|
Scientific Title of Study
|
Effects of individualized homeopathic medicines in hypothyroidism: Double-blind,
randomized, placebo-controlled, feasibility trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U111-1264-3900 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sk Monsur Alam |
| Designation |
Lecturer, Dept. of Repertory |
| Affiliation |
D. N. De Homoeopathic Medical College and Hospital |
| Address |
Research OPD, Room No 12; 12, Gobinda Khatick Road, Tangra, Kolkata
Kolkata
WEST BENGAL
700046
India |
| Phone |
8240152722 |
| Fax |
|
| Email |
drmonsur1982@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Shyamal Kumar Mukherjee |
| Designation |
Principal and Administrator |
| Affiliation |
D. N. De Homoeopathic Medical College and Hospital |
| Address |
Principals Chamber, Administrative Division, 12, Gobinda Khatick Road, Kolkata
Kolkata
WEST BENGAL
700046
India |
| Phone |
9831113383 |
| Fax |
|
| Email |
shyamalmukhergee@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Md Jamil Molla |
| Designation |
3rd BHMS undergraduate student |
| Affiliation |
D. N. De Homoeopathic Medical College and Hospital |
| Address |
Research OPD, Room no. 12, 12, Gobinda Khatick Road, Kolkata
Kolkata
WEST BENGAL
700046
India |
| Phone |
9064608556 |
| Fax |
|
| Email |
jamilmolla999@gmail.com |
|
|
Source of Monetary or Material Support
|
| D. N. De Homoeopathic Medical College and Hospital, 12, Gobinda Khatick Road, Tangra,
Kolkata, West Bengal 700046 |
|
|
Primary Sponsor
|
| Name |
D N De Homoeopathic Medical College and Hospital |
| Address |
12, Gobinda Khatick Road, Tangra, 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 |
| Sk Monsur Alam |
D. N. De Homoeopathic Medical College and Hospital |
Research OPD, Room no 12, 12, Gobinda Khatick Road, Tangra, Kolkata, West Bengal 700046
Kolkata
WEST BENGAL |
8240152722
drmonsur1982@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E039||Hypothyroidism, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized homeopathic medicines |
It is planned as administering indicated homoeopathic remedies in centesimal potencies, as decided appropriate to the case or
condition. Each dose shall
consist of 4 globules (no. 30) of cane sugar, medicated with the indicated medicine (preserved in 90% v/v ethanol), to be taken
orally on clean tongue with
empty stomach; dosage and
repetition depending upon the
individual requirement of the
cases. All medicines will be procured from a Good Manufacturing Practice
(GMP)-certified firm. Route of administration: Oral. All the patients will be given general advices on dietary management focusing on restricting goitrogenic foods including cabbage, cauliflower, soya beans, etc. Duration of therapy: 3 months. |
| Comparator Agent |
Placebo |
Placebo, identical in appearance with and indistinguishable from
the medicine. Each dose of placebo shall consist of 4 globules (no. 30) of cane sugar, moistened with rectified spirit, to be taken
orally on clean tongue with
empty stomach; dosage and
repetition depending upon the
individual requirement of the
cases. All sundry items will be procured from a Good
Manufacturing Practice
(GMP)-certified firm. Route of
administration: Oral. All the patients will be given general advices on dietary management focusing on restricting goitrogenic foods including cabbage, cauliflower, soya beans, etc. Duration of therapy: 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Newly diagnosed cases of hypothyroidism (serum TSH 4.25 μIU/ml or more) (2018/2019 ICD-10 Code E03.9) and not taking levothyroxine sodium
2. Age 18-65 years
3. Patients of either sex
4. Patients who are literate and capable of filling the questionnaire and providing
informed consent. |
|
| ExclusionCriteria |
| Details |
1. Blood TSH above 50 mIU/ml
2. Patients suffering from congenital hypothyroidism
3. Patients with psychiatric diseases
4. Pregnancy, puerperium and lactation
5. Cases suffering from any other uncontrolled systemic illness or life threatening infections or any vital organ failure
6. Cases already undergoing homeopathic treatment for any chronic purpose
7. Substance abuse and/or dependence |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Blood TSH level |
At baseline and after 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Blood FT3 and FT4 |
At baseline and after 3 months |
| Zulewski clinical score for hypothyroidism |
At baseline and after 3 months |
| Thyroid symptoms questionnaire |
At baseline and after 3 months |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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)
|
08/03/2021 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet, to be published |
|
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
Response - Clinical Study Report
Response - Analytic Code
- 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 - Data are available indefinitely at (Link to be included www.dndeofficial.org/).
- For how long will this data be available start date provided 01-07-2022 and end date provided 30-06-2027?
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
|
Hypothyroidism is a condition in which the thyroid gland doesn’t produce enough thyroid hormone, resulting disruption of heart rate, body temperature and all aspects of metabolism. Hypothyroidism is found in about 2% of the UK population and in India overall prevalence is 10.95%. Standard treatment for hypothyroidism involves daily use of the synthetic thyroid hormone levothyroxine (Levo-T, Synthroid, others) with various adverse effects. Homeopathy remains a popular choice of treatment among sufferers, yet evidence of efficacy trial with individualized homeopathy is scarce. In this double-blind, randomized, placebo-controlled trial at D. N. De Homoeopathic Medical College and Hospital, 32 patients suffering from hypothyroidism will be randomized to receive either individualized homeopathic medicines (verum; n=16) or identical-looking placebo (control; n=16). We aim to address the feasibility issues of conducting a definitive efficacy trial of individualized homeopathic medicines in treatment of hypothyroidism and to investigate whether there are any differences in outcomes between these two groups over 3 months of intervention. Thyroid profiles (TSH, FT3 and FT4), Zulewski clinical score for hypothyroidism (ZCSH) and Thyroid symptoms questionnaire (TSQ) will be used as the primary and secondary outcome measures respectively. Feasibility issues will be checked and comparative analysis will be carried out to examine group differences, if any. Results will be published in scientific journals. |