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CTRI Number  CTRI/2023/04/051311 [Registered on: 05/04/2023] Trial Registered Prospectively
Last Modified On: 05/04/2023
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 treatment of thyroid disorders in children and adults 
Scientific Title of Study   A double-blind, randomized, placebo-controlled trial evaluating add-on individualized homoeopathic medicines to standard care in improving signs and symptoms of hypothyroidism in children and adults 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
U1111-1289-9197  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Himani Jain 
Designation  Postgraduate Trainee 
Affiliation  D. N. De Homoeopathic Medical College and Hospital 
Address  Dept. of Materia Medica (OPD NO. PG2) and Obs-Gynae (OPD NO. 4), Medicine (OPD No. 1) 12, Gobinda khatick Road, Tangra

Kolkata
WEST BENGAL
700046
India 
Phone  6291487627  
Fax    
Email  jain26994@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Md Sakhawat Hossain 
Designation  Professor and Head 
Affiliation  D N De Homoeopathic Medical College & Hospital 
Address  Dept.of Materia Medica (OPD NO. PG2), 12, Gobinda Khatick Road, Tangra

Kolkata
WEST BENGAL
700046
India 
Phone  9433852961  
Fax    
Email  imdrmsh@gmail.com  
 
Details of Contact Person
Public Query  
Name  Md Sakhawat Hossain 
Designation  Professor and Head 
Affiliation  D N De Homoeopathic Medical College & Hospital 
Address  Dept.of Materia Medica (OPD NO. PG2), 12, Gobinda Khatick Road, Tangra

Kolkata
WEST BENGAL
700046
India 
Phone  9433852961  
Fax    
Email  imdrmsh@gmail.com  
 
Source of Monetary or Material Support  
D. N. De Homoeopathic Medical College and Hospital, 12, Gobinda Khatick Road, Tangra, Kolkata 700046, West Bengal 
 
Primary Sponsor  
Name  D N De Homoeopathic Medical College Hospital 
Address  12, Gobinda Khatick Road, Tangra, Kolkata 700046, West Bengal 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
Nil  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Himani Jain  D N De Homoeopathic Medical College and Hospital, Govt. of West Bengal  OPD PG-2 and Obs-Gynae (Room no.4), Medicine (Room No -1), Dept of Materia Medica, Gobinda Khatick Road, Tangra
Kolkata
WEST BENGAL 		 6291487627

jain26994@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional EthicsCommittee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E039||Hypothyroidism, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Identical-looking placebos plus standard care  This group will receive levothyroxine and placebo, identical in appearance with the verum. Each dose will consist of 4 cane sugar globules no. 40, moistened with 90% v/v ethanol, to be taken orally on clean tongue with empty stomach; dosage and repetition will be maintained depending upon the individual requirement of the cases. All sundry items will be procured from a Good Manufacturing Practice (GMP)certified firm. Both the medicines and placebos will be re-packed in identical glass bottles and labeled with code, name of medicine, potency, and will be dispensed according to the random number list. Duration of therapy: 3 months. Route of administration: Per oral 
Intervention  Individualized Homeopathic Medicines plus standard care  Intervention is planned as administering levothyroxine therapy plus individualized homeopathic medicines. It is usually started with low dose 50 microgram of L-thyroxine daily and increased every 2 to 3 week to optimum of 100 to 200 micro gram per day according to the clinical response. In addition to it, indicated homeopathic medicines in centesimal potencies (CH). Each dose will consist of 4 cane sugar globules no. 40 moistened with the indicated medicine (preserved in 90 percent volume by volume ethanol), to be taken orally on clean tongue with 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 teeth within 30 minutes of taking the globules and will be asked to suck the globules rather than simply swallowing those. Single individualized medicines will be prescribed on each occasion taking into account presenting symptom totality, clinical history details, constitutional features, miasmatic expressions, repertorization using HOMPATH and 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. Duration of therapy 3 months. Route of administration: Per oral 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1) Patients suffering from hypothyroidism [ICD –E03.9], newly diagnosed cases with serum TSH more than 10 µIU/ml), confirmed by biochemical tests
2) Age between 10 and 65 years
3) Patients of either sex or transgender
4) Providing with written informed consent and/or assent
5) Illiterate people will be interviewed by the investigators maintaining adequate privacy to fill up the scales or questionnaire.
 
 
ExclusionCriteria 
Details  1. Patients suffering from congenital hypothyroidism, subclinical hypothyroidism .
2. Vulnerable population - Unconscious, non-ambulatory, too sick for consultation, disabled, terminally ill or critically ill patients, mentally incompetent people
3. Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life or any organ failure.
4.Pregnant and puerperal women, lactating mothers
5. Patients with the habit of tobacco chewing and/or smoking, alcoholism and/or any other form(s) of substance abuse and/or dependence.
6.Self-reported immune-compromised state
7.Already undergoing homeopathic treatment for chronic disease within last 6 months.
8. Simultaneous participation in any other clinical trial 
 
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 
Zulewski clinical score   Baseline, every month, up to 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Serum TSH, T3, and T4  Baseline and after 3 months 
Thyroid specific patient reported outcomes  Baseline, every month, up to 3 months 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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)   15/04/2023 
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 Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   None yet 
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. 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.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [jain26994@gmail.com].

  6. For how long will this data be available start date provided 01-01-2026 and end date provided 31-12-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   Hypothyroidism is one of the most common endocrinal disorders under the medical concern, and its incidence is gradually increasing day-by-day. Currently, the standard treatment is thyroid replacement therapy with Levothyroxine; however, a substantial proportion of patients who reach biochemical treatment targets have persistent complaints. There is consensus that treatment should be indicated in a patient in a more comprehensive way, for long as it takes for physical and mental effects to subside. Though the use of homoeopathic medicines is prevalent globally to treat the condition, rigorous research evidence in support of homoeopathy in hypothyroidism has remained compromised. Under such circumstances, we intend to undertake this research project to evaluate the efficacy and safety of homeopathic medicines in the treatment of hypothyroidism in children and adults. A double-blind, randomized, placebo-controlled trial will be taken up on 64 children and adults with hypothyroidism at D. N. De Homoeopathic Medical College & Hospital. Participants will be randomized to receive either homeopathic medicines plus standard care, or identical-looking placebo pills plus standard care. Primary outcome measure is Zulewski clinical score, to be measured at baseline, every month, up to 3 months. Secondary outcome measures are serum TSH, T3 and T4, to be measured at baseline and after 3 months; and Thypro questionnaire, to be measured at baseline, and every month, up to 3 months. Comparative analysis will be carried out to detect group differences. Results will be published in scientific journals. 
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