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
|
|
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
|
|
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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