| CTRI Number |
CTRI/2025/03/082005 [Registered on: 07/03/2025] Trial Registered Prospectively |
| Last Modified On: |
07/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the effect of vachadi gana churna and haridradi gana churna in medoroga (dyslipidemia) |
|
Scientific Title of Study
|
Randomised comparative clinical study to evaluate the efficacy of vachadi gana churna and haridradi gana churna in the management of medoroga w.s.r. to dyslipidemia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Monika mahawar |
| Designation |
PG Scholar |
| Affiliation |
Madan mohan malviya government ayurved college udaipur |
| Address |
Opd no 1 kayachikitsa department Madan Mohan Malviya
Government Ayurved College Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
9461069499 |
| Fax |
|
| Email |
monikarj1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Monika mahawar |
| Designation |
PG Scholar |
| Affiliation |
Madan mohan malviya government ayurved college udaipur |
| Address |
Opd no 1 kayachikitsa department Madan Mohan Malviya
Government Ayurved College Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
9461069499 |
| Fax |
|
| Email |
monikarj1998@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Monika mahawar |
| Designation |
PG Scholar |
| Affiliation |
Madan mohan malviya government ayurved college udaipur |
| Address |
Opd no 1 kayachikitsa department Madan Mohan Malviya
Government Ayurved College Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
9461069499 |
| Fax |
|
| Email |
monikarj1998@gmail.com |
|
|
Source of Monetary or Material Support
|
| Madan mohan malviya government ayurved college udaipur rajasthan pin 313001 |
|
|
Primary Sponsor
|
| Name |
Madan mohan malviya government ayurved college udaipur |
| Address |
Madan mohan malviya government ayurved college udaipur rajasthan 313001 |
| Type of Sponsor |
Government medical college |
|
|
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 monika mahawar |
Madan mohan malviya government ayurved college udaipur |
OPD no.1 Kayachikitsa department Madan mohan malviya government ayurved college udaipur rajasthan 313001
Udaipur
RAJASTHAN |
9461069499
monikarj1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutinal ethics committee mmm govt ayurved college ambamata udaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E784||Other hyperlipidemia. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vachadi gana churna, Reference: Astang hridya sutrasthana 15/35,36, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: Lukewarm water), Additional Information: NA | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Haridradi gana churna, Reference: Astang hridya sutrasthana 15/35,36, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: Lukewarm water), Additional Information: NA |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
INCLUSION CRITERIA
1.Patients between the age group of 20 to 70 years of either both of sex.
2.Diagnosed cases of Dyslipidemia & Medoroga on the basis of criteria given by NCEP ATP3 (Serum Cholesterol equal or more than 200 mg/dl, Serum Triglycerides equal or more than 150mg/dl, LDL Cholesterol equal or more than 130mg/dl, HDL Cholesterol less than 40mg/dl), Any one of these.
3.Willing and able to participate in the study for 2 months.
4.Patients having lakshana of Medoroga as described in Madhava Nidana. |
|
| ExclusionCriteria |
| Details |
1.Patients having medical history of
a.Unstable Angina, Myocardial Infarction, Uncontrolled Hypertension (Diastolic Blood Pressure more than 100 mmHg), Uncontrolled Diabetes Mellitus etc.
b.Impaired Renal Function (Creatinine equal or more than 2 mg /dl)
c.ALT and AST more than 2 times of upper limit of normal.
d.Patients with evidence of malignancy.
e.Pregnancy, Lactation and patients having dyslipidemia due to drugs e.g. glucocorticoids, diuretics. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief in sign and symptoms |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hemoglobin (gm%), ESR, Serum total cholesterol, serum triglycerides, LDL, VLDL & HDL level will be analysed. |
60 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 |
|
Date of First Enrollment (India)
|
15/04/2025 |
| 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="0"
Months="11"
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
|
RANDOMISED COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF VACHADI GANA CHURNA AND HARIDRADI GANA CHURNA IN THE MANAGEMENT OF MEDOROGA W.S.R. TO DYSLIPIDEMIA
There will be two group in the study. In Group A randomly selected and clinically diagnosed 30 patient of Medoroga will be given Vachadi gana churna twice a day before meal. In Group B randomly selected and clinically diagnosed 30 patient of Medoroga will be given Haridradi gana churna twice a day before meal. Both trial will be conduct for a period of 2 months. Follow up of the case will be after 15 days that is four time during treatment. Final assesment will be done after completion of two month course on the basis of subjective and laborateral assesment. |