| CTRI Number |
CTRI/2025/06/088182 [Registered on: 03/06/2025] Trial Registered Prospectively |
| Last Modified On: |
23/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Other |
|
Public Title of Study
|
Role of Homoeopathic Medicine in Obesity in children |
|
Scientific Title of Study
|
Comparative Efficacy of Individualized Homoeopathic Medicines and Fucus vesiculosus 3X in Overweight and Obese Children: Randomized, Single Blind 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 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
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, Janakpuri, New Delhi, India, Pin code- 110058 |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Homoeopathy |
| Address |
Central Council for Research in Homoeopathy, Jawahar Lal Nehru Chikitsa Avum Anusandhan Bhawan, 61-65, Institutional Area, Opposite D Block Janakpuri |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| 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 G R C Reddy |
Clinical Research Unit(Homoeopathy) |
Room No 304 Department: SCSP, Division: Clinical research, Address:
Old maternity Hospital Campus, tirupati-517507, Chittoor District, Andhra Pradesh
Chittoor
ANDHRA PRADESH |
9441208007
dr.grcreddy@gmail.com |
| Dr Pankhuri Mishra |
Dr DP Rastogi Central Research Institute |
Room No 205 Department: Technical(Homoeopathy), Division: Clinical research, Address:
A-1/1 Opp HCL, Sector 24, Noida, Uttar Pradesh 201301
Gautam Buddha Nagar
UTTAR PRADESH |
9968533904
drpankhccrh@gmail.com |
| Dr Ashish Shivadikar |
Regional Research Institute (H) |
Room no. -009,Department- Homoeopathy, Division-Clinical research, Address:
Plot no. 38,39, Khargar,Navi Mumbai, Maharashtara- 410210
Mumbai
MAHARASHTRA |
7021436030
ashishshivadikar@gmail.com |
| Dr Deepthi Gilla |
Regional Research Institute(H) |
Room no.9 Department: Out-patient Department Division: Clinical Research , Address:
Street Number 4, Vikrampuri, Habsiguda, Hyderabad, Telangana 500007
Hyderabad
TELANGANA |
8111990221
drdeepthigilla@gmail.com |
| Dr Tanya Aggarwal |
Regional Research Institute(H) |
Room No 101, Department: SCSP, Division: Clinical Research, Address:
Chhota Pathuram, Siliguri, West Bengal 734011
Darjiling
WEST BENGAL |
9873744058
dr.tanyaaggarwal@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: E66||Overweight and obesity, |
|
|
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 |
7.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Participants with age 7 to 18 years, both sexes. Children of 7 to 18 years of age with BMI greater than one SD and lesser than three SD; participants with fasting serum glucose lesser than 126mg/dl |
|
| ExclusionCriteria |
| Details |
Participants already undergoing treatment(homoeopathic, nutritional) for obesity within last 3 months. Participants currently using metformin, orlistat, insulin, other anti-diabetic medication;contraceptive pills;thiazide;antipsychotics using these medicines regularly over the last 15 days. Suffering from any condition that can prevent physical exercises like walking, aerobic exercises; suffering from uncontrolled hypertension; suffering from pre-diagnosed or self reported Down syndrome and intellectual disabilities; refusing to comply with the instructions of LSM, refusing assent for the homoeopathic treatment |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Body Mass Index for all age groups |
Assessed monthly till end of 12 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in weight, height, waist circumference,waist-hip ratio, lean muscle mass,body fat percentage, lipid profile, liver function test, thyroid profile,fasting glucose,fasting insulin and HbA1c, physical activity Questionnaire, HRQOL |
Assessed monthly till end of 12 months |
|
|
Target Sample Size
|
Total Sample Size="296"
Sample Size from India="296"
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)
|
15/06/2025 |
| 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 single blind randomized study and will be undertaken at 5 units of central council for research in Homoeopathy with an objective to evaluate the efficacy of individualized homoeopathic medicines and fucus vesiculosus 3x in overweight and obese children. The objective of the study is to assess the changes in Body Mass index among overweight and obese children and other physical parameters |