| CTRI Number |
CTRI/2025/07/091346 [Registered on: 21/07/2025] Trial Registered Prospectively |
| Last Modified On: |
12/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [treatment] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare effectiveness between Asankashay Ghanavati and Trikatu Churna in the management of Sthaulya for 90 days. |
|
Scientific Title of Study
|
A Randomized Comparative Clinical Trial to Evaluate the Efficacy of Asankashay Ghanavati and Trikatu Churna in the Management of Sthaulya. |
| 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 Shivanjali Ashok Thorat |
| Designation |
PG Scholar |
| Affiliation |
PDEAs College of Ayurved and Research Centre,Nigdi, Pune |
| Address |
3rd floor,Kayachikitsa department,PDEAs College of Ayurveda and research centre,Nigdi Pradhikaran,Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9067981332 |
| Fax |
|
| Email |
anjali46339@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhishek Taksale |
| Designation |
Associate Professor |
| Affiliation |
PDEAs College of Ayurved and Research Centre, Nigdi, Pune |
| Address |
3rd floor,Kayachikitsa department,PDEAs college of ayurveda and research centre,Nigdi Pradhikaran,pune
3rd floor, Kayachikitsa department, PDEAs College of Ayurved and Research Center, Nigdi, Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9011061293 |
| Fax |
|
| Email |
taksaleabhishek@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivanjali Ashok Thorat |
| Designation |
PG Scholar |
| Affiliation |
PDEAs College of Ayurved and Research centre,Nigdi,Pune |
| Address |
3rd floor,Kayachikitsa department,PDEAs college of Ayurveda and research centre,Nigdi Pradhikaran,Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9067981332 |
| Fax |
|
| Email |
anjali46339@gmail.com |
|
|
Source of Monetary or Material Support
|
| 3rd floor,Kayachikitsa department,PDEAs college of Ayurveda and research centre,Nigdi Pradhikaran,Pune
Pune
Maharashtra
411044
India |
|
|
Primary Sponsor
|
| Name |
PDEAs College of Ayurved and Research Centre |
| Address |
PDEAs college of ayurveda and research centre,Nigdi Pradhikaran,Pune 411044 |
| 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 Shivanjali Ashok Thorat |
PDEAs college of ayurveda and research centre |
3rd floor,Kayachikitsa department,PDEAs college of ayurveda and research centre,Nigdi Pradhikaran,Pune
Pune
MAHARASHTRA |
9067981332
anjali46339@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee PDEAs College of Ayurveda and Research Center, Nigdi, Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E669||Obesity, unspecified. Ayurveda Condition: MEDOVRUDDHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Trikatu Churna, Reference: Ashtanghruday,Adhyay 6,shloka164, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -Madhu), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Asankashay Ghanvati, Reference: Sahastrayog,adhyay 3,shloka 27, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -Madhu), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Body Mass Index : 25.0-35.0 kg/m2
Patients having following symptoms:
1.Ati kshudha(excess hunger)
2.Ati trushna(excess thurst)
3.Ati swed(excess sweat)
4.Shwasadhikya(breathlessness)
5.Nidradhikya(excess sleep)
6.Aayas akshamata(fatigue) |
|
| ExclusionCriteria |
| Details |
1.Known case of Renal impairment,Ischemic heart disease,Tuberculosis,AIDS,Cancer,Cerebral disease and Hepatitis.
2.Known case of uncontrolled Diabetes mellitus,Hypertension.
3.Pregnant and lactating women. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To get reduced BMI, reduced symptomns of obesity as mentioned earlier. |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe adverse effects, if any. |
3 months |
|
|
Target Sample Size
|
Total Sample Size="88"
Sample Size from India="88"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Sthaulya can be correlated with obesity which is global issue in todays era.During the process of modernization and westernization evolution of technology has significantly replaced human work by machines and smart gadgets also due to extended work hours and lack of time in corporate areas people have started preferring packaged and processed junk food rather than freshly cooked healthy food.Also due to lack of physical activity,disturbed sleep patterns,consumption of alcohol,condition is getting serious day by day.All these factors contribute to impairment of metabolism and end up accumulating Adipose tisse in our body which leads to obesity condition.This conditiion is now causing further problems like Cancer,CVS disorders,Infertility,DM II,Sleep apnea also,psychological conditions like shame,depression,isolation,low self esteem. According to Ayurveda,food articles possesing properties like Madhur,guru,snigdha,picchil or abhishyandi gunas in higher percentage,leads to medo vruddhi or sthaulya. prevalence of obesity-44.02% in males and 41.16% in females. |