| CTRI Number |
CTRI/2026/01/101845 [Registered on: 22/01/2026] Trial Registered Prospectively |
| Last Modified On: |
22/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Therapeutic ] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A CLINICAL STUDY TO EVALUATE THE EFFICACY OF DARUHARIDRA GHANAWATI INTERNALLY IN THE MANAGEMENT OF HYPERLIPIDAEMIA WITH SPECIAL REFERENCE TO MEDOROGA |
|
Scientific Title of Study
|
A RANDOMIZED CONTROLLED CLINICAL TRIAL ON EFFICACY OF DARUHARIDRA GHANAWATI INTERNALLY IN THE MANAGEMENT OF HYPERLIPIDAEMIA WITH SPECIAL REFERENCE TO MEDOROGA |
| 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 Payal Rabbewar |
| Designation |
PG Scholer |
| Affiliation |
Government Ayurved College , Nanded |
| Address |
Room no.18,Department of Kayachikitsa,Government Ayurved
College, Nanded.
Nanded
MAHARASHTRA
431601
India
Nanded
MAHARASHTRA
431601
India |
| Phone |
9921075341 |
| Fax |
|
| Email |
payalrabbewar1506@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr PV Kulkarni |
| Designation |
Assistant Professor , KC department |
| Affiliation |
Government Ayurved College, Nanded |
| Address |
Room no.18,Department of Kayachikitsa,Government Ayurved
College, Nanded.
Nanded
MAHARASHTRA
431601
India
Nanded
MAHARASHTRA
431601
India |
| Phone |
9405365096 |
| Fax |
|
| Email |
kulk.prasad1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr PV Kulkarni |
| Designation |
Assistant Professor , KC department |
| Affiliation |
Government Ayurved College, Nanded |
| Address |
Room no.18,Department of Kayachikitsa,Government Ayurved
College, Nanded.
Nanded
MAHARASHTRA
431601
India
Nanded
MAHARASHTRA
431601
India |
| Phone |
9405365096 |
| Fax |
|
| Email |
kulk.prasad1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self sponsored,Kayachikitsa Department, Government Ayurved College, Vazirabad ,Nanded |
|
|
Primary Sponsor
|
| Name |
Dr Payal Mohan Rabbewar |
| Address |
Room no.18,Department of Kayachikitsa,Government Ayurved
College, Nanded.
Nanded
MAHARASHTRA
431601
India |
| Type of Sponsor |
Other [Self Sponsor] |
|
|
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 Payal Mohan Rabbewar |
Government Ayurved College And Hospital, Nanded |
Room no.18,Department of Kayachikitsa,Government Ayurved
College, Nanded.
Nanded
MAHARASHTRA
431601
India
Nanded
MAHARASHTRA |
9921075341
payalrabbewar1506@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E678||Other specified hyperalimentation. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Daruharidra Ghanvati , Reference: Bhavaprakasha , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Koshna Jala), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Mustadi Ghanavati , Reference: Charak samhita, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Koshna Jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1 - Patients as per diagnostic criteria
2 - Patients between age group 18-45 years
3 - Patients of either gender
4 - Irrespective of sociological condition of patients |
|
| ExclusionCriteria |
| Details |
Patients already taking medicines for Hyperlipidemia. patients having lipid levels which are out of range. Patients having any other systemic disorders with complications. Pregnant and lactating women. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the efficacy of Daruharidra ghanawati 3gm total dose devided in 3 tab BD orally with lukewarm water in the Management of increased lipid profile levels |
30 days of assessment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the effect of Daruharidra ghanawati & mustadi ghanawati in the Management of Hyperlipidemia
|
30 days of assessment |
| To study effect of Daruharidra ghanawati on BMI |
30 days of assessment |
| To study the preparation of Ghanavati |
30 days of assessment |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
05/02/2026 |
| 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="2"
Months="0"
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 - YES
- What data in particular will be shared?
Response (Others) - NIL
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
Response (Others) - NIL
- Who will be able to view these files?
Response (Others) - NIL
- For what types of analyses will this data be available?
Response (Others) - NIal
- By what mechanism will data be made available?
Response (Others) - NIL
- For how long will this data be available start date provided 13-01-2026 and end date provided 13-01-2028?
Response (Others) - NIL
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study is Randomized open labelled controlled clinical study of Daruharidra Ghanvati (3gm total dose) divided in 3 tab BD for 30 days and follow up on 0th,31st day.This study is conducted as a part of PG course at single centre.The primary outcome is decrease in lipid profile value, decrease in shariragaurava,kshudhadhikya,pipasadhikya,swedadhikya,angagandha,kshudrashwasa,decrease in weight,BMI.
|