| CTRI Number |
CTRI/2025/09/094828 [Registered on: 16/09/2025] Trial Registered Prospectively |
| Last Modified On: |
15/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Binge eating disorder in adolescents |
|
Scientific Title of Study
|
Efficacy of Add-on Homoeopathy and Cognitive Behaviour Therapy in Binge Eating Disorder in adolescents: A Randomized, Single- Blind placebo controlled Study |
| 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 Divya Taneja |
| Designation |
Research Officer(H) Scientist 3 |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Room no 309,Department:Public Health. Central Council for Research in Homoeopathy, Department: Public Health. 61-65 Institutional area, Opposite D Block, Janakpuri, New Delhi, India,Pincode-110058
South West
DELHI
110058
India |
| Phone |
9810305068 |
| Fax |
|
| Email |
drdivyataneja@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Divya Taneja |
| Designation |
Research Officer(H) Scientist 3 |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Room no 309,Department:Public Health. Central Council for Research in Homoeopathy, Department: Public Health. 61-65 Institutional area, Opposite D Block, Janakpuri, New Delhi, India,Pincode-110058
South West
DELHI
110058
India |
| Phone |
9810305068 |
| Fax |
|
| Email |
drdivyataneja@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Renu Mittal |
| Designation |
Research Officer(H) Scientist 4 |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Room no 304, Department: Scheduled Caste Sub plan. Central Council for Research in Homoeopathy, 61-65 Institutional area, Opposite D Block, Janakpuri, New Delhi,India, Pincode-110058
South West
DELHI
110058
India |
| Phone |
9717511115 |
| Fax |
|
| Email |
renumittal8@gmail.com |
|
|
Source of Monetary or Material Support
|
| Project Fund of Central Council for Research in Homoeopathy, Ministry of Ayush, Govt of India |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Homoeopathy, New Delhi |
| Address |
Jawahar Lal Nehru Bhartiya Chikitsa Avum Anusandhan Bhawan,61-65, Institutional Area, Opposite D Block Janakpuri 110058 |
| Type of Sponsor |
Government funding agency |
|
|
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 |
| Dr Kathika Chattopadhyay |
Baksons Homoeopathic Medical College and Hospital |
Research and Development Cell Room Number 401, Baksons Homoeopathic Medical College and Hospital Plot No 36 B, Knowledge Park, Phase-1, Greater Noida-201306, Dist. Gautam Budha Nagar (U.P.)
Gautam Buddha Nagar
UTTAR PRADESH |
9910860193
dr.kathika@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Central Ethics Committee of Central Council for Research in Homoeopathy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F508||Other eating disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic medicine alongwith Cognitive Behavioural therapy |
Individualized Homoeopathic medicines in centesimal potency will be prescribed as per the principles of Homoeopathy.
Cognitive behavioral therapy (CBT) will be given based on a clear treatment plan designed on a 6-month plan. |
| Comparator Agent |
Placebo alongwith Cognitive Behavioural therapy |
Placebo identical in taste, shape, and color to the homoeopathic medicine.
Cognitive behavioral therapy (CBT) will be given based on a 6-month treatment plan designed for the Binge Eating Disorder. |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1.Participants with ages between 12-18 years, of all gender.
2.Participants meeting Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for Binge Eating Disorder that is Recurrent episodes of binge eating, an episode of which includes eating, in a discrete period of time and a sense of lack of control over eating during the episode also the criteria includes binge-eating episodes which are associated with three (or more) of eating much more rapidly than normal, or eating until feeling uncomfortably full, or eating large amounts of food when not feeling physically hungry, or eating alone because of feeling embarrassed by how much one is eating, or feeling disgusted with oneself, depressed, or very guilty afterwards, or marked distress regarding binge eating is present. Along with this the criteria includes that binge eating occurs, on average, at least once a week for three months and the binge eating is not associated with the recurrent use of inappropriate compensatory behavior (for example, purging) and does not occur exclusively during the course of anorexia nervosa, bulimia nervosa or avoidant/restrictive food intake disorder. |
|
| ExclusionCriteria |
| Details |
1.Participants already undergoing treatment (Allopathic, Ayurveda, Homoeopathic) for any other systemic disorders.
2.Participants currently using anti-diabetic medication; contraceptive pills; medications with effect on lipid metabolism i.e. thiazide and loop diuretics, beta and alpha receptor blockers; anti-epileptic drugs, anti-psychotics medications regularly over the last 1 month or more
3.Participants currently using immunosuppressive treatments
4.Morbid obesity – BMI greater than 40 kg/m2
5.Severe obesity (BMI greater than 30 kg/m2 ) with related comorbidities such as hypertension or dyslipidemia
6.HbA1c 6.5 percent or higher
7.Hypertriglyceridemia greater than or equal to 130 mg/dL
8.Pregnant and lactating women
9.Participants suffering from systemic and other endocrine disorders e.g. uncontrolled Hypertension, Type I/Type II Diabetes Mellitus, Diabetes Insipidus, Cushing Syndrome, Addison’s disease, Insulin Resistance syndrome
10.Participants suffering from other eating disorders such as anorexia nervosa, and bulimia nervosa.
11.Participants with psychiatric disorders viz. schizophrenia, bipolar disorder, Major Depressive Disorder, on medication for depression, anxiety, phobias etc.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the changes in symptoms of binge eating disorders using Eating Disorder Examination Questionnaire |
Assessed at baseline, 03 months , and 06 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the change in anxiety associated symptoms General Anxiety Disorder-7 |
Assessed at baseline, 03 months , and 06 months |
| To assess changes in Body Image related aptitudes. |
Assessed at baseline, 03 months , and 06 months |
| To assess Lipid profile (Serum triglycerides, LDL, HDL, Total cholesterol), Blood Sugar (Fasting, HbA1c) |
Assessed at baseline, 03 months , and 06 months. |
| To assess Blood pressure and Obesity |
Assessed at every month till 06 months |
| To assess Serum Fasting Insulin levels |
Assessed at baseline and 06 months. |
| To assess Hormonal profile [Thyroid profile (T3, T4, TSH), FSH, LH, Prolactin, Testosterone, E2 Estradiol, progesterone] for subset of participants (that is participants who are overweight or obese or BMI above 25 kg/m square) |
Assessed at baseline and 06 months. |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
01/10/2025 |
| 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="3"
Months="0"
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 randomized, single-blind, placebo-controlled pilot study is designed to evaluate the efficacy of add-on Homoeopathy with Cognitive Behavioural Therapy (CBT) in adolescents with Binge Eating Disorder. The study will be conducted at the Peripheral OPD / OPD of Bakson Homoeopathic Medical College & Hospital, Greater Noida and OPD of CCRH institute/units over a 3 years period. A total of 90 participants aged above 12- 18 years meeting inclusion criteria based on DSM-5 criteria will be enrolled. The primary outcome will be assessed by changes in anxiety associated symptoms General Anxiety Disorder-7 at baseline, 03 months and 6 months and secondary outcomes will include Body Image related aptitudes assessed at baseline, 03 months and 6 months and assessment of risk factors for metabolic syndrome - Lipid profile (Serum triglycerides, LDL, HDL, Total cholesterol), Blood Sugar (Fasting, HbA1c) assessed at baseline, 03 months, and 06 months. Blood pressure and Obesity assessed at every month till 06 months. Serum Fasting Insulin levels, and Hormonal profiling [Thyroid profile (T3, T4, TSH), FSH, LH, Prolactin, Testosterone, E2 Estradiol, progesterone] for subset of participants (i.e. participants who are overweight or obese or BMI above 25 kg/m square) assessed at baseline and 06 months.
|