| CTRI Number |
CTRI/2025/07/090336 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
20/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A comparative clinical trial to study the efficacy of Asana Churna and
Guduchyadi Churna in the management of Sthaulya (Overweight)in children of age group
10 to 16 Years. |
|
Scientific Title of Study
|
A Randomised comparative clinical trial to study the efficacy of Asana Churna and Guduchyadi Churna in the management of Sthaulya [Overweight] in children of age group10 to 16 Years. |
| 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 Aishwarya Khedkar |
| Designation |
PG scholar |
| Affiliation |
PDEAs College of Ayurved and Research Centre Nigdi Pune |
| Address |
PDEAs College of Ayurveda and Research Centre Balrog Department,Nigdi Pune 411044 Maharashtra India
Pune
MAHARASHTRA
411044
India |
| Phone |
9834534938 |
| Fax |
|
| Email |
aishwaryakhedkar15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhavi Deodas |
| Designation |
HOD & Professor |
| Affiliation |
PDEAs College of Ayurved and Research Centre Nigdi Pune |
| Address |
PDEAs College of Ayurved and Research Centre Balrog Department Nigdi Pune 411044 Maharashtra India
Pune
MAHARASHTRA
411044
India |
| Phone |
9423010818 |
| Fax |
|
| Email |
drdeodasms@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Madhavi Deodas |
| Designation |
HOD and Professor |
| Affiliation |
PDEAs College of Ayurved and Research Centre Nigdi Pune |
| Address |
PDEAs College of Ayurved and Research Centre Balrog Department Nigdi Pune 411044 Maharashtra India
Pune
MAHARASHTRA
411044
India |
| Phone |
9423010818 |
| Fax |
|
| Email |
drdeodasms@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs College of Ayurveda and Research centre Nigdi Pune |
|
|
Primary Sponsor
|
| Name |
PDEAs College of Ayurved and Research Centre Nigdi Pune |
| Address |
PDEAs College of Ayurved and Research Centre Balrog Department Third Floor Nigdi Pune 411044 Maharashtra 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 Aishwarya Khedkar |
PDEAs Ayurveda Rugnalaya and Snowbell Multi Speciality Hospital |
Ayurveda Rugnalaya OPD no 118 Balrog Department Ayurveda division Sector 27 Nigdi Pradhikaran Pune MAHARASHTRA 411044 Pune MAHARASHTRA
Pune
MAHARASHTRA |
9834534938
aishwaryakhedkar15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Chairperson Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E663||Overweight. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Asana churna, Reference: Sahastrayoga, Route: Oral, Dosage Form: Churna/ Powder, Dose: 100(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -madhu), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Guduchyadi Churna , Reference: Yogratnakar , Route: Oral, Dosage Form: Churna/ Powder, Dose: 100(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -madhu), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
1. Children diagnosed with Sthaulya having two or more Clinical features of
Sthaulya as Kshudhadhikya, Shariragaurava, Swedabadh, Daurgandha,
Daurbalya ,Trushnadhikya.
2. Patients having BMI 25 - 29.9.
3. Weight more than 86 to 95 percentile of that age [i.e. Overweight]. |
|
| ExclusionCriteria |
| Details |
1. Overweight due to known case of endocrine disorder like Hypothyroidism, inborn error of metabolism.
2. Known case of Congenital anomalies, known case of any acute infection, and major renal diseases. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessment Criteria :
• Subjective Parameter –
• Kshudhadhikya [Increased Appetite]
• Shariragaurava [Heaviness in the body]
• Swedabadh [Excessive Sweating]
• Daurgandha [Body Odour]
• Daurbalya [Generalized Weakness]
• Trushnadhikya [ Excessive thirst]
Objective Parameter –
• Body weight [Kg – in percentile]
• BMI [Kg/M 2]
• Waist Circumference [cm]
• Hip Circumference [cm]
• Waist / Hip circumference ratio
• Mid arm circumference [cm] |
60 days with follow up on 7th 15th 45th 60th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe and compare the adverse effect if any during treatment. |
60 days with follow up on 7th 15th 45th 60th day |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
05/08/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
In modern science, drugs are used for obesity which reduces absorption of food or causes suppression of appetite but all these have their limitations due to their Side effects. This treatment may generate economic burden on family. So, by following the Ayurveda Principles for healthy lifestyle and with effective treatment We can beat the obesity and prevalence can be reduced. Here, Asana churna is a trial drug chosen from sahastrayog. Asan is a tikta , kashaya rasatmak , katu vipaki and ushna virya dravya . With the help of laghu, rooksha guna and it’s ras, virya ,vipaka Asan helps to reduce Kapha and medodushti. |