| CTRI Number |
CTRI/2024/03/064697 [Registered on: 22/03/2024] Trial Registered Prospectively |
| Last Modified On: |
02/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Study To Find Out The Efficacy Of Homoeopathic Medicines In The Management Of Constitutional Childhood Obesity |
|
Scientific Title of Study
|
A Prospective Interventional Study To Find Out The Efficacy Of Homoeopathic Medicines In The Management Of Constitutional Childhood Obesity |
| 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 Jay Prakash Tripathi |
| Designation |
PhD Scholar |
| Affiliation |
Jawaharlal Nehru Homoeopathic Medical College |
| Address |
Jawaharlal Nehru Homoeopathic Medical College, Department of Practice of Medicine, P.G. Division, Parul University, P.O. Limda, Ta. Waghodia, Dist. Vadodara, Gujarat-391760 India
Vadodara GUJARAT 391760 India |
| Phone |
9425300211 |
| Fax |
|
| Email |
drjptripathi88@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Kirtida Desai |
| Designation |
Professor & HOD, Medicine Department |
| Affiliation |
Jawaharlal Nehru Homoeopathic Medical College |
| Address |
Jawaharlal Nehru Homoeopathic Medical College, Department of Practice of Medicine, P.G. Division, Parul University, P.O. Limda, Ta. Waghodia, Dist. Vadodara, Gujarat-391760 India
Vadodara GUJARAT 391760 India |
| Phone |
9574424363 |
| Fax |
|
| Email |
kirtida.desai@paruluniversity.ac.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Jay Prakash Tripathi |
| Designation |
PhD Scholar |
| Affiliation |
Jawaharlal Nehru Homoeopathic Medical College |
| Address |
Jawaharlal Nehru Homoeopathic Medical College, , Department of Practice of Medicine, P.G. Division, Parul University, P.O. Limda, Ta. Waghodia, Dist. Vadodara, Gujarat-391760 India
Vadodara GUJARAT 391760 India |
| Phone |
9425300211 |
| Fax |
|
| Email |
drjptripathi88@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Homoeopathic Medical College & Hospital, Parul University, Vadodara |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Nehru Homoeopathic Medical College & Hospital |
| Address |
Jawaharlal Nehru Homoeopathic Medical College, , Department of Practice of Medicine, P.G. Division, Parul University, P.O. Limda, Ta. Waghodia, Dist. Vadodara, Gujarat-391760 India |
| Type of Sponsor |
Private medical college |
|
|
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 Jay Prakash Tripathi |
Government Homoeopathic Medical College Bhopal& Hospital |
Room No 33
Department Of Pediatrics, Government Homoeopathic Medical College & Hospital
Ayush Campus, Beside Kaliyasot Dam, Mact Hills, Bhopal MP- 462003
Bhopal MADHYA PRADESH |
9425300211
drjptripathi88@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Government Homoeopathic Medical College & Hospital, Bhopal MP |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E669||Obesity, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic Medicine selected on the basis of individualization and Totality of Symptoms of a patient |
Individualized Homoeopathic Medicine, which could be any medicines and are derived from the Homoeopathic source and prepared according to the Homoeopathic Pharmacopeia. The selection of the intervention medicine would be done after assessing the Patient as a whole including their mental as well as physical plane. Patient’s condition of disease and BMI would also be noted and thereafter the selection would on the basis of individualization and Totality of Symptoms of a patient from the proved Homoeopathic medicines.Dose of Selected Homoeopathic Medicine shall consist of 6-8 globules (no. 30) of cane sugar 1 to 3 times in a day according to demand of the case. Route of Administration-Oral (Sublingual). Selected Individualized Homoeopathic medicine prescribed in 30,200,1M Potency. The Potency selection, dose and repetition of medicine will done according to demand of the case, with the consideration of potency selection criteria such as susceptibility, sensitivity, vitality, changes in structural and functional level and degree of correspondence to the remedies selected, strictly done on the basis of homoeopathic principles. The patients will be advice to follow instructions given. Duration of therapy: 12 months. |
| Comparator Agent |
Placebo, indistinguishable in appearance from Homoeopathic medicine |
The dose, frequency,and route of administration of placebo shall will be same as intervention agent. each dose consist of 6-8 globules (no. 30) of cane sugar, to be taken orally (Sub lingual). All the other instructions and advice will be same as intervention arm Except this arm will receive placebo. Each dose of placebo will be identical to centesimal, but will be prepared with
Non-medicated globules. The patients will be advice to follow instructions given to intervention agent. Duration of therapy: 12 months.
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1.Children suffering from constitutional obesity
2.Children 5 to 18 years age group children
3.Obese children using BMI Scale (BMI ≥ 95th percentile or BMI greater than 2 standard deviations above the WHO Growth Reference Data 5 to 19 years of Age)
4.Parents giving consent for child to participate in the study and with regular follow up
|
|
| ExclusionCriteria |
| Details |
1.The cases which did not fulfill the inclusion criteria
2.Children having pathological obesity
3.Children who require Emergency, Immune compromised, congenital disease and suffering from other chronic disease including systemic affections of irreversible pathological changes in the body
4.Subjects under the treatment of other system of medicine.
5.Parents not giving consent for child to participate in the study and irregular follow up
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To ascertain the efficacy of homoeopathic medicines in the management of Constitutional obesity in children and assessing improvement of suffering and reduction of obesity by using BMI Scale with MYMOP tool |
12 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the predisposing factors associated with constitutional obesity among children as per homoeopathic prospective and prevention of obesity and its future complications |
12 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
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/04/2024 |
| 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="1" 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
|
Overweight and obesity are defined as abnormal or excessive fat accumulation that may impair health. A child is considered obese when there is excess accumulation of fat in all subcutaneous tissues and other parts of the body. Obesity is regarded as a pandemic with potential disasters consequences for human health, obesity have its adverse effect on both mental and physical health of the person it can lead to both morbidity and mortality. In most of the children with obesity, environmental factors (95% Cases) is the main etiological factor, most children with obesity do not have any organic causes they are suffering from Constitutional obesity. Only 5% Cases with obesity have organic cause like Endocrinal, Hypothalamic, Drugs Genetic syndrome, Monogenic disorder etc. are suffering from Pathological Obesity The global prevalence of obesity has doubled from 1990 to 2015. Worryingly, the increase is more in children than in adults. In just three decades, the number of school-going children and adolescents with obesity has increased by 10-fold. The International Association for the Study of Obesity and International Obesity Task Force estimate that 200 million school children worldwide are either overweight or obese. The prevalence of overweight or obesity in Indian children is around 20% leads to significant risk of life style disease in future. The prevalence of overweight and obesity among children and adolescents aged 5-19 has risen dramatically from just 4% in 1975 to just over 18% in 2016 In 2016, more than 1.9 billion adults aged 18 years and older were overweight. Over 340 million children and adolescents aged 5-19 were overweight or obese. In 2019, an estimated 38.2 million children were overweight or obese lived in Asia. It is predicted that by 2025 there will be 17 million obese children in India In this trial the investigator intend to assess the efficacy of Individualized Homoeopathic Medicine in the management of constitutional childhood obesity. In Children age 5 to 18 year following inclusion and exclusion criteria on 90 patients in a single blind, randomized, placebo controlled design in the outpatient of Department of Pediatrics in Government Homoeopathic Medical College & Hospital Ayush Campus, Beside Kaliyasot Dam, Mact Hills, Bhopal – 462003. The patients will be prescribed either Individualized Homoeopathic Medicine or Identical placebo and will be minimum 6 follow up, initially in every 15 days followed by monthly for 12 months. Data will be gathered at base line and after 12 months. Randomization will be computer generated. Assessing improvement of suffering and reduction of obesity by using BMI scale with MYMOP tool. The collected data will be subjected to statistical analysis. The main aim is to ascertain the efficacy of homoeopathic medicines than placebo in the management of Constitutional obesity in children |