| CTRI Number |
CTRI/2025/07/091839 [Registered on: 28/07/2025] Trial Registered Prospectively |
| Last Modified On: |
26/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative study to the efficacy of Virechan Karma and Vyoshadi Guggulu in management of Medoroga with special reference to Dyslipidemia |
|
Scientific Title of Study
|
A comparative study to evaluate the efficacy of Virechan Karma and Vyoshadi Guggulu in management of Medoroga with special reference 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 |
Dr Vandana Barde |
| Designation |
PG Scholar |
| Affiliation |
Pt khushilal sharma government autonomous ayurveda college and institute bhopal MP |
| Address |
PG Department of Panchakarma, room no111 Pt. Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal (M.P.)
Bhopal
MADHYA PRADESH
462007
India |
| Phone |
9589365914 |
| Fax |
|
| Email |
bardevandna8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kamini Soni |
| Designation |
Professor |
| Affiliation |
pt khushilal sharma Ayurveda College and Institute, Bhopal mp |
| Address |
PG Department of Panchakarma, room no111 Pt. Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal (M.P.)
Bhopal
MADHYA PRADESH
462007
India |
| Phone |
8770037353 |
| Fax |
|
| Email |
skamini382@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vandana Barde |
| Designation |
PG Scholar |
| Affiliation |
pt khushilal sharma Ayurveda College and Institute, Bhopal mp |
| Address |
PG Department of Panchakarma, room no111 Pt. Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal (M.P.)
Bhopal
MADHYA PRADESH
462007
India |
| Phone |
9589365914 |
| Fax |
|
| Email |
bardevandna8@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pt. Khushilal Sharma Government (Autonomous)Ayurveda College and Institute Science Hills Bhopal, MP India 462007 |
|
|
Primary Sponsor
|
| Name |
Pt. Khushilal Sharma Government Autonomous Ayurveda College and Institute Science Hills Bhopal MP |
| Address |
PG Department of Panchakarma, Room No.111 Pt. Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal MP |
| Type of Sponsor |
Government funding agency |
|
|
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 Vandana Barde |
Pt. Khushilal Sharma Ayurveda College and Institute, Bhopal MP |
PG Department of Panchakarma, Room No.111 Pt. Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal MP
Bhopal
MADHYA PRADESH |
9589365914
bardevandna8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) Pt Khushilal Sharma Government Ayurveda Institute Bhopal (MP) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E789||Disorder of lipoprotein metabolism, unspecified. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | virechana-karma, विरेचन-कर्म | (Procedure Reference: Charak Samhita sutra Sthan chapter 21 , Procedure details: (Procedure Reference: Charak Samhita sutra Sthan Chapter 21, Procedure details: Virechana karma 7-11 days according to patients Kosth)
(1) Medicine Name: Trivritadi Kashayam, Reference: Sahastra Yog (Pratham Prakarn Kashaya Yog /1-2
Route: Oral, Dosage form: Kwatha/Kashaya, Dose:40(ml)
Frequency: bd
Duration: 1 Months
(1) Medicine Name: Vyoshadi Guggulu, Reference: Ashtanga Hridaya Chikitsa chapter 21/50
Route: Oral Dosage Form:
Vati/Gutika/Tablets
Dose:500mg, Frequency: bd
Duration: 1 Months
)
(1) Medicine Name: Vyoshadi Guggulu , Reference: Ashtanga Hridaya chikitsa chapter 21/50, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Duration: 1 Months | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Vyoshadi Guggulu ,, Reference: Ashtanga Hridaya chikitsa chapter 21/50, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: -Lukewarm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
31.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients between the aged 31-50 years of either sex, fulfilling the diagnostic criteria and willing to participate in the clinical study.
Patients fit for Virechana karma.
BMI greater than 25 and smaller than 35kg/m2 |
|
| ExclusionCriteria |
| Details |
Patients suffering from type 1 diabetes mellitus and uncontrolled diabetes mellitus type 2(HbA1c greater than 10 percent), coronary artery disease.
Drug induced or uncontrolled dyslipidemia.
Patient having systemic illness like tuberculosis, carcinoma and endocrine disorders or major illness like renal liver disorder.
Patients having the past history of myocardial infraction and unstable angina.
Patients having clinical features of CCF (Congestive cardiac failure).
Patients with poorly controlled hypertension (greater than 160/100mmhg).
Pregnant and lactating mother. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| It is expected that at the end of the study we will be able to demonstrate the effect of Virechan Karma and Shaman Drug Vyoshadi Guggulu in the management of Medoroga Dyslipidemia |
12 Month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
24/12/2025 |
| 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="1"
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 - NO
|
|
Brief Summary
|
It is expected that at the end of the study we will be able to demonstrate the effect of Virechana karma and Shaman drug Vyoshadi Guggulu in the management of Medoroga Dyslipidemia. |