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CTRI Number  CTRI/2024/04/065888 [Registered on: 18/04/2024] Trial Registered Prospectively
Last Modified On: 13/11/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Homoeopathic management of Hypothyroidism 
Scientific Title of Study   Efficacy of individualized homoeopathic medicines as standalone or as an add on to standard of care on symptom profile of hypothyroidism – an open label feasibility cohort multiple randomized controlled trial. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR LIPIPUSHPA DEBATA 
Designation  RESEARCH OFFICER SCIENTIST 3 
Affiliation  Under Central Council for Research in Homoeopathy Ministry of Ayush Govt of India 
Address  CENTRAL RESEARCH INSTITUTE (HOMOEOPATHY) SECTOR 2 JANKIPURAM EXTENSION Room no 219 2nd Floor

Lucknow
UTTAR PRADESH
226031
India 
Phone  7755014040  
Fax    
Email  drlipi08@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  VARANASI ROJA 
Designation  RESEARCH OFFICER SCIENTIST 3 
Affiliation  CENTRAL COUNCIL FOR RESEARCH IN HOMOEOPATHY Ministry of Ayush Govt of India 
Address  61 65 INSTITUTIONAL AREA JANAKPURI NEW DELHI 3rd Floor

West
DELHI
110058
India 
Phone  9999454036  
Fax    
Email  varanasiroja@gmail.com  
 
Details of Contact Person
Public Query  
Name  LIPIPUSHPA DEBATA 
Designation  RESEARCH OFFICER SCIENTIST 3 
Affiliation  Under Central Council for Research in Homoeopathy Ministry of Ayush Govt of India 
Address  CENTRAL RESEARCH INSTITUTE (HOMOEOPATHY) SECTOR 2 JANKIPURAM EXTENSION 2nd Floor Room no 219

Lucknow
UTTAR PRADESH
226031
India 
Phone  07755014040  
Fax    
Email  drlipi08@gmail.com  
 
Source of Monetary or Material Support  
Central Council for Research in Homoeopathy JAWAHARLAL BHARTIYA CHIKITSA AVUM HOMOEOPATHY ANUSANDHAN BHAWAN 61 65 INSTITUTIONAL AREA OPPOSITE D BLOCK JANAKPURI NEW DELHI 110058 
 
Primary Sponsor  
Name  CCRH 
Address  Jawaharlal Bhartiya Chikitsa avum Homoeopathy anusandhan Bhawan. 61-65, Institutional area, Opp D-Block, janakpuri, New Delhi- 110058 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR LIPIPUSHPA DEBATA  CENTRAL RESEARCH INSTITUTE (HOMOEOPATHY)  Room no. 219, 2nd Floor, HC/NH, SECTOR-2, JANKIPURAM EXTENSION, LUCKNOW- 226031
Lucknow
UTTAR PRADESH 		 7755014040

drlipi08@gmail.com 
DR GURUDEV CHOUBEY  DR ANJALI CHATTERJEE REGIONAL RESEARCH INSTITUTE FOR HOMOEOPATHY  Room no. 4, 50, RAJENDRA CHATTERJEE ROAD KOLKATA 700035
Kolkata
WEST BENGAL 		 7908955160

gurudev.choubey@gmail.com 
DR HARPREET KAUR  DR D P RASTOGI CENTRAL RESEARCH INSTITUTE FOR HOMOEOPATHY  Room no. 224, A-1/1, SECTOR 24 OPPOSITE HCL, NOIDA UTTAR PRADESH- 201301
Gautam Buddha Nagar
UTTAR PRADESH 		 9810863650

drharpreetmd@gmail.com 
DR R S KRISHNESWARI  NATIONAL HOMOEOPATHY RESEARCH INSTITUTE IN MENTAL HEALTH   Room no. 1, SACHIVOTHAMAPURAM PO- KOTTAYAM DISTRICT KERALA- 686532
Kottayam
KERALA 		 8903255833

krishneswarirs@gmail.com 
DR LIYI KARSO  REGIONAL RESEARCH INSTITUTE FOR HOMOEOPATHY  Room no. 101, GROUND FLOOR CARI OLD BUILDING BORSOJAI PO- BELTOLA GUWAHATI -781028
Kamrup
ASSAM 		 7628990495

liyikarso@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
CENTRAL COUNCIL FOR RESEARCH IN HOMOEOPATHY CENTRAL ETHICS COMMITTEE  Approved 
CENTRAL RESEARCH INSTITUTE (HOMOEOPATHY) LUCKNOW INSTITUTIONAL ETHICAL COMMITTEE  Approved 
DR D P RASTOGI CENTRAL RESEARCH INSTITUTE OF HOMOEOPATHY NOIDA INSTITUTIONAL ETHICAL COMMITTEE   Approved 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
NATIONAL HOMOEOPATHY RESEARCH INSTITUTE IN MENTAL HEALTH KOTTAYAM INSTITUTIONAL ETHICAL COMMITTEE   Approved 
REGIONAL RESEARCH INSTITUTE FOR HOMOEOPATHY GUWAHATI INSTITUTIONAL ETHICAL 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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Individualised Homoeopathic medicines and Standard treatment (Levothyroxine)  Homoeopathic medicines will be administered orally and repeated as per need of case till one year. Levothyroxine will be administered orally empty stomach daily for one year 
Intervention  Individualised homoeopathic medicines standalone  Patient will be administered only homoeopathic medicines orally till one year 
Comparator Agent  Placebo  Placebo will be given orally twice daily for one year 
Comparator Agent  Standard treatment (Levothyroxine)  Levothyroxine will be administered to patients- one tablet daily in empty stomach till one year 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  i. Patients suffering from hypothyroidism (serum TSH within normal range or ≤ 20 μIU/ml) for at least last 3 months and undergoing standard therapy, i.e. Levothyroxine sodium in personalized dosage as decided by the conventionally trained endocrinologists.
ii. Fresh cases of hypothyroidism (undergoing no treatment) with Serum TSH within 10- 20 μIU/ml.
iii. Age: 15- 50 years.
iv. Literate and illiterate patients; ability to understand Hindi.
v. Patients giving written consent to participate.
 
 
ExclusionCriteria 
Details  i) TSH above 20 μIU/ml
ii) Patients suffering from congenital hypothyroidism
iii) Patients with psychiatric diseases
iv) Pregnancy and lactation
v) Cases suffering from any other uncontrolled systemic illness or life-threatening infections or any vital organ failure
vi) Cases already undergoing homoeopathic treatment for any chronic diseases
vii) Substance abuse and/or dependence
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Changes in symptom profile related to hypothyroidism and Quality of life in patients at of 12 months (Zulewski’s clinical score at every month, Thyroid symptom questionnaire and SF-8 Questionnaire for QOL at every follow up).  12 months 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate
a) Changes in TSH level at every 4 weeks.
b) Changes in Blood thyroid profile at 3rd, 6th, 9th, and 12th month.
c) Reduction in dosage of LT-4 intake in add on group during a period of 12 month.
d) Number of patients requiring LT-4 by 12 months in standalone group.
e) Adverse events if any.
 		 3rd- 12th month 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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 3 
Date of First Enrollment (India)   01/05/2024 
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="3"
Months="0"
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 - NO
Brief Summary  

Title

Efficacy of individualized homoeopathic medicines as standalone or as an add on to standard of care on symptom profile of  Hypothyroidism – an open label feasibility cohort multiple randomized controlled trial

Short Title/ Public title

Homoeopathic treatment of Hypothyroid  Cases

Methodology

Cohort multiple RCT

Study Duration

30 M0NTHS + 6 months Extension= 3 years

Principal Investigator (PI)

Dr. Lipipushpa Debata

Study sites

Co- investigators at the site

CRIH, Lucknow,

Dr. Lipipushpa Debata, R. O. (H), S-3

DDPR CRI, Noida

Dr. Harpreet Kaur, R. O. (H), S-1

DACRRI, Kolkata

Dr. Gurudev Choubey, R. O. (H), S-3

NHRIMH, Kottayam

Dr. K. C. Muraleedharan, A.D (H), Dr. R.S. Krishneswari, Asst. Prof.

RRI (H), Guwahati

Dr. Liyi Karso, R. O. (H), S-2

Co-ordinator at Hqr

Dr. Varanasi Roja, R. O. (H), S-3

Objectives

Primary Objectives:

i)   To evaluate the efficacy of individualized homoeopathic medicines as standalone or as add on to standard of  care on symptom profile and quality of life of patients suffering from hypothyroidism.

Number of Subject

Convenient sample of 200 patients (40 patients in each Centre) 

Main Inclusion Criteria

i)    Patients suffering from hypothyroidism and under LT4 with TSH within normal range or <20 μIU/ml.

ii)  Fresh cases of Hypothyroidism with TSH between 10-20 μIU/ml

iii) Age: 15-50 years

iv) Literate and illiterate patients able to understand hindi.

v)   Patients giving written consent to participate.

Study Product

Individualised Homoeopathic medicines according to symptom similarity. Potency and dose will be given as per homoeopathic principles.

Duration of administration

12 months

Statistical methodology

All analyses shall be conducted using SPSS version 20.0. The normality of the data distribution shall be assessed before undertaking any inferential statistics. For categorical and ordinal data nonparametric test will be applied.  For metric or continuous data, parametric tests shall be applied.
 
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