| CTRI Number |
CTRI/2026/01/101585 [Registered on: 19/01/2026] Trial Registered Prospectively |
| Last Modified On: |
19/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study to Evaluate the Benefit of a Herbal Formulation in People with High Cholesterol |
|
Scientific Title of Study
|
Evaluation of Efficacy of Polyherbal Formulation in Treatment of Hyperlipidemia: 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 |
Vd Vaishnavi Bhausaheb Ghodake |
| Designation |
PG Scholar Kayachikitsa |
| Affiliation |
Dr. D.Y. Patil College of Ayurveda and Research Centre |
| Address |
OPD NO.5 department of kayachikitsa Dr.D.Y.Patil College of Ayurveda and Research Centre pimpri pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9403805214 |
| Fax |
|
| Email |
vaishughodake024@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gunvant H Yeola |
| Designation |
M.D. Ph.D. Kayachikitsa |
| Affiliation |
Dr. D.Y. Patil College of Ayurveda and Research Centre |
| Address |
OPD NO.5 department of kayachikitsa Dr.D.Y.Patil College of Ayurveda and Research Centre pimpri pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9028321955 |
| Fax |
|
| Email |
gunvantayurved@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vd Vaishnavi Bhausaheb Ghodake |
| Designation |
PG Scholar Kayachikitsa |
| Affiliation |
Dr. D.Y. Patil College of Ayurveda and Research Centre |
| Address |
OPD NO.5 department of kayachikitsa Dr.D.Y.Patil College of Ayurveda and Research Centre pimpri pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9403805214 |
| Fax |
|
| Email |
vaishughodake024@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD NO. 5 Department of Kayachikitsa Dr. D.Y. Patil College of Ayurved and Research Centre, Pimpri pune 411018 Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Vd Vaishnavi Bhausaheb Ghodake |
| Address |
OPD NO.5 department of kayachikitsa Dr.D.Y. Patil College of Ayurveda and Research Centre,Pimpri pune 411018 |
| 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 |
| Vd Vaishnavi Bhausaheb Ghodake |
Dr. D. Y. Patil College of Ayurved and Research Centre, Pimpri, Pune |
OPD NO.5 And IPD of KAYACHIKITSA department Dr. D.Y. Patil College of Ayurved and Research centre pimpri pune 411018
Pune
MAHARASHTRA |
09403805214
vaishughodake024@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. DYPCA and RC INSTITUTIONAL ETHICS COMIMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Hyperlipidemia |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Polyherbal formulation , Reference: Ashtanghridayam chikitsa 1/49, Bhavprakash , Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: luke warm water), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Tablet | Tab. Atorvastatin 10mg once a day after food at night orally |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Newly detected case of Hyperlipidemia Patients |
|
| ExclusionCriteria |
| Details |
Plasma levels greater than equals to 240 mg/dL for Total cholesterol, greater than equals to 190 mg/dL for Low-density lipoprotein, and greater than equals to 500 mg/dLÂ for Triglycerides.
Pregnant women & lactating mothers.
Patient with renal, hepatic, coronary heart diseases |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in sr. cholesterol, sr. triglycerides, sr. LDL |
2 weeks and 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in Ayurvedic parameters related to Ama, Agni & Medo Dushti after intervention. |
2 weeks & 4 weeks |
|
|
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 |
|
Date of First Enrollment (India)
|
09/03/2026 |
| 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="6"
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
|
A Randomized Comparative Clinical Study to Evaluate the Efficacy of Polyherbal formulation in the treatment of Hyperlipidemia 500mg 2 tablet orally twice a day after food will be given for one month with follow ups of 15th and 30th day. comparison group will be taking Tab. Atorvastatin 10 mg once a day after food at night orally.
|