| CTRI Number |
CTRI/2026/04/107472 [Registered on: 02/04/2026] Trial Registered Prospectively |
| Last Modified On: |
02/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Ayurvedic study of Herbal drug tablet in overweight and high Cholesterol level persons to reduce the weight and blood Cholesterol level. |
|
Scientific Title of Study
|
A Randomized Control Study to Evaluate Effectiveness of Bilwadi Panchmool Ghana Vati in Comparison to Fenofibrate in Management of Increased Triglyceride Levels |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pushkaraj Shrikant Kulkarni |
| Designation |
Professor, PhD scholar |
| Affiliation |
Siddhakala Ayurved College and Research Center Sangamner |
| Address |
OPD No. 1 Kayachikitsa Department, Siddhakala Ayurved Mahavidyalay , pimparne Road, Sangmner khurd, Sangmner,Dist.Ahilyanagar, Maharashtra422605
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9921234470 |
| Fax |
|
| Email |
pushkarajk19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anil Sharma |
| Designation |
Professor and Dean |
| Affiliation |
Faculty of Indian Medical System , SGT University Gurgaon. |
| Address |
001-Ground floor, Dean Office, FIMS SGT University, Gurgaon-Badli road, Chandu, Budhera, Gurgaon, Haryana.
Gurgaon
HARYANA
122505
India |
| Phone |
9416085092 |
| Fax |
|
| Email |
anilherbals@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pushkaraj Shrikant Kulkarni |
| Designation |
Professor , PhD scholar |
| Affiliation |
Siddhakala Ayurved College and Research Center Sangamner |
| Address |
OPD No. 1 Kayachikitsa Department, Siddhakala Ayurved Mahavidyalay , pimparne Road, Sangmner khurd, Sangmner,Dist.Ahilyanagar, Maharashtra422605
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9921234470 |
| Fax |
|
| Email |
pushkarajk19@gmail.com |
|
|
Source of Monetary or Material Support
|
| Siddhakala Ayurved Mahavidyalay, Pimparne road , Sangamer |
|
|
Primary Sponsor
|
| Name |
Pushkaraj Shrikant Kulkarni |
| Address |
Siddhakala Ayurved Mahavidyalay, Pimparne road , Sangamner |
| Type of Sponsor |
Other [self] |
|
|
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 Pushkaraj Shrikant Kulkarni |
Siddhakala Ayurveda Mahavidyalaya And Hospital, Pimparne Road, Sangmaner |
Siddhakala Ayurveda Mahavidyalaya And Hospital, Pimparne Road,Department Of Kayachikitsa OPD No 1 Sangamner Khurd, Sangmaner, Ahilyanagar, Maharashtra, India, Pincode- 422605
Ahmadnagar
MAHARASHTRA |
9921234470
pushkarajk19@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SGT University of ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E668||Other obesity. Ayurveda Condition: KAPAVRUDDHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Tab Fenofibrate 80 mg | Tab Fenofibrate80mg can be given OD after lunch | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: BilwadiPanchmool ghan vati, Reference: Charak sutrashan 21/24, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: madhu), Additional Information: (1) Medicine Name: BilwadiPanchmool ghan vati, Reference: Charak sutrasthan 21/24, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: Medicine Name-BilwadiPanchmool ghan vati Refernce- CHARAK Sutrasthan 21/24 Dose- 500mg Route-oral Form-Vati Frequency- BD Bhaishajya kal-Abhakta Anupan- Madhu early in morning and evening can be taken |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosed patients of sthoulya or medoroga or kapha vrudhi and increased Triglyceride levels (after fasting for 10hrs) from OPD & IPD.
2. Suitable case paper Performa will be designed for the study.
3.100 patients of increased triglyceride levels (Can be Compare with Kaphavrudhi or medorog or hypertriglyceridemia) will be selected randomly 50 for each group.
4. Medicine will be repeated every 15 days after follow up upto 90 days.
Patients will be selected on the basis of Lipid profile reports.
4. Patients having increased Triglycerides level more than 150 mg per dL.
|
|
| ExclusionCriteria |
| Details |
1. The patients below 18 yrs. And above 55 yrs will be not be included.
2. patients suffering from major diseases like medasara, mansara and pregnant women will not be selected. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of BilwadiPanchmool Ghana Vati with Fenofibrate in reducing triglyceride levels (after fasting for 10 hrs). |
0th Day (Baseline Assessment) , 15th Day (Follow Up ) for 3 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) To compare the effect of BilwadiPanchamool Ghana vati on triglyceride levels with the effect of fenofibrate .
2) To compare the effect of BilwadiPanchamoolghanavati and fenofibrate on Lipid Profile ( Cholesterol, HDL , LDL levels)
|
0th Day (Baseline Assessment ) Follow up will be taken at an interval of 15 days for 3 months.
|
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
27/04/2026 |
| 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
|
This Study is a Randomized Open Labelled Controlled Clinical Trial Comparing the Safety And Efficacy Of BilwadiPanchamool Ghana Vati 500mg Twice A Day And Controlled Drug Tablet Finofibrate 80mg Once A Day For 3 Months in 100 Patients Of Increased Triglyceride Levels Divided in Two Groups And The Effect On Weight , BMI , Triglyceride Level, Lipid Profile (Cholesterol ). |