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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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

 
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