| CTRI Number |
CTRI/2025/08/093594 [Registered on: 25/08/2025] Trial Registered Prospectively |
| Last Modified On: |
23/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the Effectiveness of Khadir Vati and Atorvastatin in Managing High Cholesterol: A Clinical Trial |
|
Scientific Title of Study
|
Evaluation of Comparative Efficacy of Khadir Vati Versus Atorvastatin in the Management of Dyslipidemia - 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 Shital Gulabrao Chavan |
| Designation |
PG Scholar |
| Affiliation |
Mahtma Gandhi Ayurved College Hospital and Research Centre salod hirapur wardha |
| Address |
Room no 30 Department Of Kayachikitsa Mahatma Gandhi Ayurved College Hospital And Research Centre Salod hirapur Wardha
MAHARASHTRA
442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
9112455234 |
| Fax |
|
| Email |
shitalchavan141@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sadhana Misar Wajpeyi |
| Designation |
Professor and HOD |
| Affiliation |
Mahtma Gandhi Ayurved College Hospital and Research Centre salod hirapur wardha |
| Address |
Room no 30 Department Of Kayachikitsa Mahatma Gandhi Ayurved College Hospital And Research Centre Salod hirapur Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9763732083 |
| Fax |
|
| Email |
wajpayeisadhana@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shital Gulabrao Chavan |
| Designation |
PG Scholar |
| Affiliation |
Mahtma Gandhi Ayurved College Hospital and Research Centre salod hirapur wardha |
| Address |
Room no 30 Department Of Kayachikitsa Mahatma Gandhi Ayurved College Hospital And Research Centre Salod hirapur Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9112455234 |
| Fax |
|
| Email |
shitalchavan141@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Ayurved College Hospital And Research Centre Salod Hirapur wardha |
|
|
Primary Sponsor
|
| Name |
Mahatama Gandhi Ayurveda College Hospital and Research Centre Salod Hirapur Wardha Maharashtra |
| Address |
Room No 30 Department Of Kayachikitsa Mahatma Gandhi Ayurved College Hospital And Research Centre Salod Hirapur Wardha Maharashtra 4420001 India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 SHITAL CHAVAN |
MAHATMA GANDHI AYURVED COLLEGE HOSPITAL AND RESEARCH CENTRE |
Room No 30 Department Of Kayachikitsa Mahatma Gandhi Ayurved College Hospital And Research Centre Salod Hirapur Wardha Maharashtra 4420001 India
Wardha
MAHARASHTRA |
9112455234
shitalchavan141@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| stitutional Ethics CommitteeMahtma Gandhi Ayurved College Hospital and Research Centre In |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E785||Hyperlipidemia, unspecified. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Khadir Vati, Reference: Bhavprakash Nighntu Vatadi Varga 30 -32, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -Lukewarm Water), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Atorvastatin | Tab Atorvastatin 10 mg will be orally administered at bed time after food with water for 45 days. |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient willing to Participate with written informed consent
Patient between age group 30 to 60 years of either sex
Newly diagnosed cases of Dyslipidemia according to National Cholesterol Education Program and Adult Treatment Panel III (NCEP ATP III 2004) as follows
TCH more than or equal to 200 mg per dL and or
LDL C between 130 to 189 mg per dL and or
Serum TG between 150 to 499 mg per dL and or
Serum HDL C less than 40mg per Dl
|
|
| ExclusionCriteria |
| Details |
Known cases of major illness like cardiovascular disorder, hepatic, & renal disorders
Dyslipidemia due to consumption of drug such as glucocorticoids
Subjects having MI (myocardial infarction), Angina, Stroke, TIA (transient ischemic attack), major cardiovascular surgeries in 6 months
Patients already on statins or other lipid-lowering agents and blood thinner
Pregnant and Lactating women
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the efficacy of Khadir Vati and Atorvastatin on Lipid Levels – Total cholesterol, Triglyceride, LDL (Low density lipoprotein) and HDL (High density lipoprotein).
|
at baseline
45 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| comparison & assessment of efficacy of Khadir Vati & Atorvastatin on Lipid Levels – Total cholesterol, Triglyceride, LDL (Low density lipoprotein) & HDL (High density lipoprotein) |
at baseline
6 weeks 3 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
11/12/2025 |
| 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="2"
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
|
The volunteers will be informed about the study protocol. Willing participants will be randomly selected as per computer generated table. Clinical research format will be prepared and validated. Prior to the study approval will be taken from IEC, MGACHRC, Salod (H) Wardha and CTRI registration will be done. After selection, each participant will be tested individually and selected according to selection criteria. They are divided into two groups the trial is a Randomized open labelled Standard controlled equivalence clinical trial. It will include a 45 days treatment period and a follow up period of 0th and 45th day. |