| CTRI Number |
CTRI/2024/07/069816 [Registered on: 02/07/2024] Trial Registered Prospectively |
| Last Modified On: |
23/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of musta aragwadhadi powder udwartana (churna massage) in childhood obesity |
|
Scientific Title of Study
|
A single arm interventional study to evaluate the role of musta aragwadhadi powder udwartana in sthaulya w.s.r. to childhood nutritional 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 Ankita |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Ayurveda, Jaipur |
| Address |
Department of kaumarbhritya, room no 222,National Institute of Ayurveda,deemed to be university, Amer road, Jorawar singh gate,
Jaipur
RAJASTHAN
302002
India |
| Phone |
9460494230 |
| Fax |
|
| Email |
silluankita@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shrinidhi Kumar |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Ayurveda, |
| Address |
Department of Kaumarbhritya,National Institute of Ayurveda, Amer road, Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
7877151575 |
| Fax |
|
| Email |
ashanidhiacharya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shrinidhi Kumar |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Ayurveda, |
| Address |
Department of Kaumarbhritya,National Institute of Ayurveda, Amer road, Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
7877151575 |
| Fax |
|
| Email |
ashanidhiacharya@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda,Amer road,Jaipur,Rajasthan 302002 India |
|
|
Primary Sponsor
|
| Name |
national institute of ayurveda |
| Address |
National Institute of Ayurveda, Amer road, Jaipur,Rajasthan 302002 India |
| 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 |
| Dr Ankita |
National Institute of Ayurveda Hospital |
OPD no.5 Bal Roga department National Institute of Ayurveda Hospital, Amer road, Jaipur 302002
Jaipur
RAJASTHAN |
9460494230
silluankita@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:E660||Obesity due to excess calories. Ayurveda Condition: ATISTHAULYAMÂ (KEVALA-KAPHA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | udvartanam, उदà¥à¤µà¤°à¥à¤¤à¤¨à¤®à¥ | (Procedure Reference: charaka samhita sutrasthaan chapter 23, Procedure details: Total duration of study (3 months) will be divided
into 6 sitting of 15 days. For first 7 days Udwartana will be done as per SOP by Musta Aragwadhadi
Powder followed by rest for 7 days along with Phase I obesity protocol. Same will be repeated in
each sitting.)
|
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
1 The children between the age group of 5-16 year in either sex presenting with Clinical Features of Sthaulya W.S.R. to Childhood nutritional obesity.
2 Diagnosed cases of nutritional obesity.
3 Individuals having BMI between 85th-95th percentile of CDC growth chart 2000
|
|
| ExclusionCriteria |
| Details |
1 Children suffering from obesity due to endocrinal, chromosomal, familial tendency (non-nutritional obesity)
2 Children with existing co-morbidity related to obesity.
3 Children suffering from other systemic disorder and on drug therapy.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in BMI |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change the quality of life and to correct life style habits. |
3 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/09/2024 |
| Date of Study Completion (India) |
08/10/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
08/10/2025 |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
As per incidence quoted in 2016, there are around 340 million of adolescents comes under the obesity group and major portion is contributed by age group of 5-16 years. The prevalence of overweight and obesity among children and adolescents aged 5-19 has raised dramatically from just 4% in 1975 to over 18% in 2016 and 18% of girls and 19% of boys were overweight as per this incidence record. Meanwhile few studies from India suggests prevalence of childhood and adolescent nutritional obesity range from 3% to 29% indicating higher prevalence in urban than in rural area. Although, recently published data of obesity from Jaipur Rajasthan is not available, Pan India prevalence of obesity in children is in between 5-18 years is 12.5% having percentage between 85 to 95% As the pathophysiological events of Sthaulya clearly indicates abnormal lifestyle with excess intake of food and abnormal sleep and food hygiene, improper sleep and less exercise and sedentary lifestyle predisposes, excess formation of Medhodhatu along with other Dhatus which obstructs pathway of Vata in GIT leading and further stimulation of Agni and increasing the Kshuda (hunger). Samhitas also consider the same under Rasapradoshajavikaras. Ayurveda attributes physical, pshycological and dietic factors as major causative factor for Sthaulya and consider AtiSthaulya as one of the Nindita purusha. Ayurveda explains Guru and Aptarpan as major treatment principle of obesity suggesting intake of heavy food with less nourishing or with less caloric value along with other management principles like Shodhana, Rukshana, Langhana, etc. |