| CTRI Number |
CTRI/2025/08/092511 [Registered on: 06/08/2025] Trial Registered Prospectively |
| Last Modified On: |
03/01/2026 |
| 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 clinical study to campare effects of Asanadi Ghan Vati with Amritadya Guggul on reducing weight in a patient of Sthaulya or Obesity |
|
Scientific Title of Study
|
Comparing The Effects of Asanadi Ghan Vati Versus Amritadya Guggul on Weight Reduction In Sthaulya bracket Obesity a Randomized Controlled Trial |
| 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 Tejasweeta Vivek Jog |
| Designation |
PhD Scholar |
| Affiliation |
Seth Govindji Raoji Ayurved Medical College |
| Address |
Department Of Kayachikitsa,Seth Govindji Raoji Ayurved Medical College,New Budhwar Peth,Samrat Chowk,Solapur
Solapur
MAHARASHTRA
413001
India |
| Phone |
9075677763 |
| Fax |
|
| Email |
tejaswee85@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vivek Chandurkar |
| Designation |
Professor |
| Affiliation |
Seth Govindji Raoji Ayurved Medical College |
| Address |
Department of Kayachikitsa,Seth Govindji Raoji Ayurved Medical College,New Budhwar Peth,Samrat Chowk,Solapur
Solapur
MAHARASHTRA
413001
India |
| Phone |
9422788569 |
| Fax |
|
| Email |
vivek.chandurkar@sgrayurved.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tejasweeta Vivek Jog |
| Designation |
PhD Scholar |
| Affiliation |
Seth Govindji Raoji Ayurved Medical College |
| Address |
Department of Kayachikitsa,Seth Govindji Raoji Ayurved Medical College,Budhwar Peth,Solapur
Solapur
MAHARASHTRA
413001
India |
| Phone |
9075677763 |
| Fax |
|
| Email |
tejaswee85@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mandsaur Institute Of Ayurveda Education And Research,Mandsaur,Madhya Pradesh,India,458001. |
| Seth Govindji Raoji Ayurved Medical College,Solapur,Maharashtra,India 413001. |
|
|
Primary Sponsor
|
| Name |
Dr Tejasweeta Vivek Jog |
| Address |
Department Of Kayachikitsa,Seth Govindji Raoji Ayurved Mahavidyalay,Samrat Chowk,Solapur,Maharashtra,India,413001 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Tejasweeta Vivek Jog |
Mandsaur Institute Of Ayurved Education And Research |
Department Of Kayachikitsa,BRNCOP Campus, Near Krishi Upaj Mandi,Bhunyakhedi,Mandsaur
Mandsaur
MADHYA PRADESH |
9075677763
tejaswee85@gmail.com |
| Dr Tejasweeta Vivek Jog |
Seth Govindji Raoji Ayurved Medical College |
Department Of Kayachikitsa,New Budhwar Peth,Samrat Chowk.
Solapur
MAHARASHTRA |
9075677763
tejaswee85@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Seth Govindji Raoji Ayurved Medical College,Solapur |
Approved |
| Sumandeep Vidyapeeth Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E65-E68||Overweight, obesity and other hyperalimentation. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Amritadya Guggul, Reference: Chakradatta Sthaulyadhikara, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -Koshnajal), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Asanadi Ghan Vati, Reference: Ashtang Hridaya Sutrastahna 15, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -Koshnajal), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects having signs and symptoms of Sthaulya as described in classical Ayurveda and Modern texts,subjects having BMI in the range of 25-35 |
|
| ExclusionCriteria |
| Details |
Drug Induced Obesity, Obesity due to certain secondary causes, Known cases of hormonal disorders ,Pregnant women, Disease associated obesity patients |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effectiveness of Asanadi Ghan Vati And Amritadya Guggul in reducing body weight in individuals diagnosed with Sthaulya over a period of 3 months duration |
Follow up will be taken on 1st,30th,60th,90th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess changes in Lipid Profile in participants receiving Asanadi Ghan Vati and Amritadya Guggul |
1st,30th,60th and 90th day |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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 4 |
|
Date of First Enrollment (India)
|
18/08/2025 |
| 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
|
This is a comparative study between two drugs to see their effects on weight reduction primarily over a duration of 3 months with follow ups on 1st,30th,60th and 90th days.Also the effects of drugs on lipid profile will be observed simultaneously.Results will be statistically comapred and analysed to draw conclusion. |