| CTRI Number |
CTRI/2025/03/082612 [Registered on: 18/03/2025] Trial Registered Prospectively |
| Last Modified On: |
26/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Behavioral
Other (Specify) [DIET] |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A STUDY TO COMPARE EFFECT OF VIDANGADI CHOORNA WITH MADHU ALONG WITH LIFESTYLE MODIFICATIONS IN MANAGING HIGH CHOLESTROL LEVELS. |
|
Scientific Title of Study
|
A COMPARATIVE CLINICAL TRIAL TO EVALUATE THE
EFFECT OF VIDANGADI CHOORNA WITH MADHU ALONG
WITH LIFESTYLE MODIFICATIONS IN BORDERLINE HIGH
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 MEGHNA JAGAJEEV |
| Designation |
PG SCHOLAR |
| Affiliation |
GOVERNMENT AYURVEDA COLLEGE , THIRUVANATHAPURAM |
| Address |
GOVERNMENT AYURVEDA COLLEGE THIRUVANANTHAPURAM
DEPARTMENT OF SWASTHAVRITTA
OP NO 2
GOVERNMENT AYURVEDA
COLLEGE PANCHAKARMA HOSPITAL, POOJAPPURA
Thiruvananthapuram
KERALA
695012
India |
| Phone |
9995038519 |
| Fax |
|
| Email |
meghnajagajeev@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MEGHNA JAGAJEEV |
| Designation |
PG SCHOLAR |
| Affiliation |
GOVERNMENT AYURVEDA COLLEGE , THIRUVANATHAPURAM |
| Address |
GOVERNMENT AYURVEDA COLLEGE THIRUVANANTHAPURAM
DEPARTMENT OF SWASTHAVRITTA
OP NO 2
GOVERNMENT AYURVEDA
COLLEGE PANCHAKARMA HOSPITAL, POOJAPPURA
Thiruvananthapuram
KERALA
695012
India |
| Phone |
9995038519 |
| Fax |
|
| Email |
meghnajagajeev@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SHEELA S |
| Designation |
PROFESSOR AND HOD DEPARTMENT OF SWASTHAVRITTA |
| Affiliation |
GOVERNMENT AYURVEDA COLLEGE , THIRUVANATHAPURAM |
| Address |
GOVERNMENT AYURVEDA COLLEGE THIRUVANANTHAPURAM
DEPARTMENT OF SWASTHAVRITTA
OP NO 2
GOVERNMENT AYURVEDA COLLEGE PANCHAKARMA HOSPITAL, POOJAPPURA
Thiruvananthapuram
KERALA
695012
India |
| Phone |
9847706888 |
| Fax |
|
| Email |
drsheelas@gmail.com |
|
|
Source of Monetary or Material Support
|
| GOVERNMENT AYURVEDA COLLEGE PANCHAKARMA HOSPITAL POOJAPPURA THIRUVANANTHAPURAM PIN 695012 KERALA INDIA |
|
|
Primary Sponsor
|
| Name |
DR MEGHNA JAGAJEEV |
| Address |
PG SCHOLAR GOVERNMENT AYURVEDA COLLEGE THIRUVANATHAPURAM
OP NO 2
DEPARTMENT OF SWASTHAVRTTA
GOVERNMENT AYURVEDA COLLEGE PANCHAKARMA HOSPITAL POOJAPPURA THIRUVANANTHAPURAM |
| 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 |
| DR MEGHNA JAGAJEEV |
GOVERNMENT AYURVEDA COLLEGE PANCHAKARMA HOSPITAL POOJAPPURA |
DEPARTMENT OF SWASTHAVRITTA
OP NO 2
GOVERNMENT AYURVEDA COLLEGE PANCHAKARMA HOSPITAL POOJAPPURA THIRUVANANTHAPURAM 695012
Thiruvananthapuram
KERALA |
9995038519
meghnajagajeev@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE(IEC),Government Ayurveda College, Thiruvanathapuram,Kerala, India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E785||Hyperlipidemia, unspecified. Ayurveda Condition: MEDOJA-VRUDDHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: VIDANGADI CHOORNAM, Reference: AROGYAKALPADRUMAM, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: HONEY), Additional Information: -along with lifestyle modification | | 2 | Comparator Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:, Pathya/Apathya:yes, Pathya:30 minutes brisk walking daily morning
and Dietary modification, Apathya:Nil |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Participants having either or all of serum total cholesterol between
200mg/dL-239mg/dL, LDL 130mg/dL-159mg/dL, Triglycerides 150mg/dL-199mg/dL |
|
| ExclusionCriteria |
| Details |
Participants with Chronic systemic illness under medication
Diagnosed case of Diabetes Mellitus
On antihpertensive medication or BP greater than 140/90mm Hg
Habit of cigarette smoking
HDL cholesterol less than 40 mg/dL
Family history of Premature Coronary Heart Disease CHD in male first degree relative less than 55 years and
CHD in female first degree relative less than 65 years
Diagnosed case of Dyslipidemia under medication
Pregnant women and lactating mother |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Changes in Serum Total Cholesterol, LDL Cholesterol,
Triglycerides, HDL Cholesterol |
0th 16th 46th day and follow up on 91st day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
24/03/2025 |
| 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="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
|
Dyslipidemia refers to abnormal amount of lipids and lipoproteins in the blood due to impairment in lipoprotein metabolism and is a major risk factor for development of Coronary artery disease. It can be correlated in ayurveda as medodushti, associated with kaphadushti and dhatwagni mandya , and as a precursor stage of medoroga and can be easily treated by effective interventions . Treatment of sthoulya can be adopted for Dyslipidemia which includes kaphamedohara, deepana, pachana, rukshana ,lekhana karmas . A Quasi experimental study will be performed in 64 participants of all sex, satisfying inclusion and exclusion criteria . Out of 64 participants , 32 each will be allocated to Intervention group (Group 1) and Comparison group (Group 2). The participants in the group 1 will be given Vidangadi choorna (6gm )with Madhu (12gm) as anupana after food twice daily along with Lifestyle modification such as dietary modifications and exercise of 30 minutes brisk walking (daily morning). Life style modification alone will be advised to Comparison group. The study period is fixed for 45 days. The serum lipid profile will be analysed before study , on 16th day , 46th day and follow up on 91th day. The data collected will be processed and conclusions will be made accordingly. |