| CTRI Number |
CTRI/2025/04/085767 [Registered on: 28/04/2025] Trial Registered Prospectively |
| Last Modified On: |
10/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Other |
|
Public Title of Study
|
Role of Homoeopathic medicines in Overweight and Obese persons with Hypothyroidism |
|
Scientific Title of Study
|
Comparative Efficacy of Individualized Homoeopathic Medicine and Fucus vesiculosus 3x in Overweight and Obese Persons with Hypothyroidism:A Randomized, Single Blind Comparative Pilot 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 Renu Mittal |
| Designation |
Research Officer Homoeopathy |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Room No 304, Department: Scheduled Caste Sub Pan
D Block Janakpuri, New Delhi
South West
DELHI
110058
India
South West
DELHI
110058
India |
| Phone |
9717511115 |
| Fax |
|
| Email |
renumittal8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Divya Taneja |
| Designation |
Research Officer Homoeopathy |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Room No 309, Department: Public Health
D Block Janakpuri, New Delhi
South West
DELHI
110058
India
South West
DELHI
110058
India |
| Phone |
9810305068 |
| Fax |
|
| Email |
drdivyataneja@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Divya Taneja |
| Designation |
Research Officer Homoeopathy |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Room No 309, Department: Public Health
D Block Janakpuri, New Delhi
South West
DELHI
110058
India
South West
DELHI
110058
India |
| Phone |
9810305068 |
| Fax |
|
| Email |
drdivyataneja@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Homoeopathy, 61-65 Institutional Area, opposite D-Block, New Delhi-110058 |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Homoeopathy |
| Address |
Central Council for Research in Homoeopathy, 61-65 Institutional Area, opposite D-Block, New Delhi-110058 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Uttam Singh |
Central Research Institute of Homoeopathy |
Room No 3
Department- Homoeopathy
Division- Clinical Research, Address:
Sector 26, Pratap Nagar, Jaipur, Rajasthan 302033
Jaipur
RAJASTHAN |
9679593673
druttam01@gmail.com |
| Dr Pankhuri Mishra |
Dr. D.P. Rastogi Central research institute of Homoeopathy |
Room No 205
Department: Technical(Homoeopathy), Division: Clinical Research, Address:
Sector 24, Noida, Uttar Pradesh 201301
Gautam Buddha Nagar
UTTAR PRADESH |
9968533904
drpankhccrh@gmail.com |
| Dr Juhi Gupta |
Government Homoeopathic Medical College and Hospital |
OPD 6 and Homoeopathy wellness centre. Department: Research AYUSH Parisar. Manit Hills, Near Kaliasot Dam, Bhopal-462003
Bhopal
MADHYA PRADESH |
9425609774
sanjanhvi@yahoo.co.in |
| Dr Deepthi Gilla |
Regional Research Institute(H) |
Room no.9,
Department: Out-patient Department, Address:
Division: Clinical Research,
Street Number 4, Vikrampuri, Habsiguda, Hyderabad, Telangana 500007
Hyderabad
TELANGANA |
8111990221
drdeepthigilla@gmail.com |
| Dr Prabhat Tiwari |
Regional Research Institute(H) |
Room No 104
Department: SCSP, Division: Clinical research, Address:
6th Cross St, Jawahar Nagar, Kavery Nagar, Reddiarpalayam, Puducherry, 605005
Pondicherry
PONDICHERRY |
9718305515
drprabhattiwari15@gmail.com |
| Dr Ramesh Bawaskar |
Regional Research Institute(H) |
Room No - 01
Department - Homoeopathy, Division: Clinical research, Address:
Plot no. 38,39, Khargar,Navi Mumbai,District – Raigad, Maharashtara- 410210
Mumbai
MAHARASHTRA |
9769888743
drbsb@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| Central Ethics Committee |
Approved |
| Institutional Ethical Committee |
Approved |
| Institutional Ethical Committee |
Approved |
| Institutional Ethical Committee |
Approved |
| Institutional Ethical Committee |
Approved |
| Institutional Ethical Committee |
Approved |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E038||Other specified hypothyroidism, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Fucus Vesiculosus |
Fucus Vesiculosus will be prescribed via oral route of administration for duration of 12 months |
| Intervention |
Individualized Homoeopathic Medicine |
Individualized homoeopathic medicines obtained after case taking will be prescribed via oral route of administration for duration of 12 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Participants with ages between 18 to 60 years; Overweight persons; obese persons as per WHO classification of BMI; participants diagnosed with Hypothyroidism and currently on regular thyroid hormone replacement treatment; participants with serum TSH more than 4.5mIU/L and lesser than 10 mIU/L( within last 6 months) |
|
| ExclusionCriteria |
| Details |
Participants already undergoing treatment for weight reduction, currently using anti-diabetic medication,contraceptive pills;anti epileptic drugs, anti psychotics; pregnant and lactating women,with a history of thyroid surgery, suffering from systemic and other endocrine disorders |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the changes in Body mass index among Overweight and obese persons with hypothyroidism |
Assessed monthly till end of 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the changes in waist circumference and waist-hip ratio, changes in HRQOL,changes in thyroid profile, changes in GPAQ, changes in lipid profile |
Assessed monthly till end of 12 months |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
16/06/2025 |
| 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)
|
Not Applicable |
| 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 - NO
|
|
Brief Summary
|
This is a Pilot, single Blind trial study and will be undertaken at the 5 units of Central Council for research in Homoeopathy with an objective to evaluate the efficacy of Individualized Homoeopathic Medicine and Fucus Vesiculosus 3x in overweight and obese persons with hypothyroidism. The objective of the study is to assess the changes in BMI among overweight and obese persons with hypothyroidism and other physical parameters |