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CTRI Number  CTRI/2019/08/020693 [Registered on: 13/08/2019] Trial Registered Prospectively
Last Modified On: 08/08/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Other 
Public Title of Study   Effect of Chavyadi Shaktu in the management of stholya in children and to restore normal physical activity and to promote the healthy life style of overweight children. 
Scientific Title of Study   Clinical study to evaluate the efficacy of chavyadi shaktu for weight management management in stholya w.s.r.to overweight in children.  
Trial Acronym  wsr 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Amita Kumari 
Designation  M.D. Scholar 
Affiliation  National Institute of Ayurveda Jaipur,Rajasthan 302002 
Address  PG Department of Balrog Jaipur National Institute of Ayurveda Jaipur, Rajasthan 302002

Jaipur
RAJASTHAN
302002
India 
Phone  7597864722  
Fax    
Email  raoamita33@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rakesh Kumar Nagar 
Designation  M.D. (Ay.) ( Assistant Professor) 
Affiliation  National Institute of Ayurveda Jaipur, Rajasthan 302002 
Address  PG Department of Balrog Jaipur National Institute of Ayurveda Jaipur, Rajasthan 302002

Jaipur
RAJASTHAN
302002
India 
Phone  9414062099  
Fax    
Email  drrknagar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rakesh Kumar Nagar 
Designation  M.D. (Ay.) ( Assistant Professor) 
Affiliation  National Institute of Ayurveda Jaipur, Rajasthan 302002 
Address  PG Department of Balrog Jaipur National Institute of Ayurveda Jaipur, Rajasthan 302002

Jaipur
RAJASTHAN
302002
India 
Phone  9414062099  
Fax    
Email  drrknagar@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Ayurveda Pharmacy Department Jaipur,Rajasthan 
 
Primary Sponsor  
Name  National Institute of Ayurveda Jaipur 
Address  PG Department of Balrog Jaipur National Institute of Ayurveda Jaipur, Rajasthan 302002 
Type of Sponsor  Government 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 
Amita Kumari  National Institute of Ayurveda Jaipur  PG Department of Balrog Jaipur National Institute of Ayurveda Jaipur, Rajasthan 302002
Jaipur
RAJASTHAN 
7597864722

raoamita33@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE NATIONAL INSTITUTE OF AYURVEDA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E66||Overweight and obesity,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Chavyadi shaktu  Dose of the Chavyadi shaktu 2 gm with 25 gm of Yava Sattu with Mastu Q.S. Total duration of the intervention will be two month clinical trial with drug and one month post drug follow up. 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  15.00 Year(s)
Gender  Both 
Details  1. Age between 10-15 years will be selected.
2. Children with Familial tendency of obesity.
3. Obesity due to sedentary lifestyle and dietary habits.
4. Children having BMI between 85th to 95th percentile of CDC growth charts 2000 
 
ExclusionCriteria 
Details  1. Children those are suffering from any systemic and endocrinal illness like DM, Hypothyroidism etc.
2. Obesity associated with chromosomal disorders/metabolic disorders.
3. Children those are already on treatment for obesity or other disorders.
4. Drug induced obesity. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the role of Chavyadi shaktu in Childhood stholya   60 Days 
 
Secondary Outcome  
Outcome  TimePoints 
To restore normal physical activity and to promote the healthy life style

 
60 Days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   16/08/2019 
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="0"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NOT YET 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Obesity is a condition where a person has accumulated so much body fat, it might have a negative effect on their health and increases the risk of other metabolic disorders such as type 2 diabetes, insulin resistance, hypertension, dyslipidaemia,  inflammation, thrombosis, obstructive sleep apnoea, cardiovascular disease, some cancers and mortality.1,2 Obesity  caused by several factors viz., social and environmental status, genetics factors, and individual preferences like age, gender, high energy and less nutrient diet pattern, regular intake of excess calories and fatty foods, lack of physical activity.3 The changeover of a rural to an urban lifestyle that is a major cause of obesity e.g. increased intake of high energy dense foods and decrease in physical activity.

Adults having body mass index (BMI) greater than or equal to 25 and 30 considered overweight and obese, respectively while in the reference of children 85th percentile and 95th percentile of BMI considered overweight and obese, respectively and it is increasing at an alarming rate throughout the globe. According to WHO the worldwide obesity has nearly tripled since 1975 and over 340 million children and adolescents aged 5-19 were overweight or obese in 2016.  In 2016, an estimated 41 million children under the age of 5 years were overweight or obese. Nearly half of the children under 5 who were overweight or obese in 2016 lived in Asia. The prevalence of overweight and obesity among children and adolescents aged 5-19 has risen dramatically from 4% in 1975 to over 18% in 2016. The rise has occurred similarly among both boys and girls. While less than 1% of children aged 5-19 year were obese in 1975, 6% of girls and 8% of boys were obese in 2016.5 The prevalence of obesity among school children in India has found between 5.74% and 8.82% and approximately 21.4% of boys and 18.5% of girls were obese in the 13-18 years age group in urban regions of South India.

In present trend of clinical practice we need to justify and prove the clinical efficacy of classical formulations on scientific parameters so Chavyadi shaktu as mentioned in Bhaishjya Ratnawali is proposed to evaluate the efficacy and utility in the treatment of obesity in children.

1. To assess the efficacy of Chavyadi Shaktu in the weight managemen in the stholya w.s.r. to obse children

2. To restore normal physical activity and to promote the healthy life style of  stholya  w.s.r. to obese children.

 

 
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