CTRI Number |
CTRI/2020/03/023742 [Registered on: 03/03/2020] Trial Registered Prospectively |
Last Modified On: |
02/03/2020 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Ayurveda |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
To see the effect of Haridradwaya Churna with and
without Vamana Karma in trating Sthaulya (Dyslipidemia). |
Scientific Title of Study
|
To evaluate the efficacy of Haridradwaya Churna with and without Vamana Karma in the management of Sthaulya w.s.r. to Dyslipidemia- A randomised comparative clinical study. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Pratik Bahute |
Designation |
PG Scholar |
Affiliation |
All India Institute of Ayurveda |
Address |
Room No. 725 Department of Panchakarma Academic block All India Institute of Ayurveda Gautampuri Sarita Vihar New Delhi
South West DELHI 110076 India |
Phone |
9403261833 |
Fax |
|
Email |
bahutepratik@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Prof Dr S H Acharya |
Designation |
Professor |
Affiliation |
All India Institute of Ayurveda |
Address |
Room No. 725 Department of Panchakarma Academic block All India Institute of Ayurveda Gautampuri Sarita Vihar New Delhi
South West DELHI 110076 India |
Phone |
9879550157 |
Fax |
|
Email |
dracharyadr@hotmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr S K Bhatted |
Designation |
Associate Professor & HOD |
Affiliation |
All India Institute of Ayurveda |
Address |
Room No. 725 Department of Panchakarma Academic block All India Institute of Ayurveda Gautampuri Sarita Vihar New Delhi
South West DELHI 110076 India |
Phone |
8851939675 |
Fax |
|
Email |
santoshbhatted@rediffmail.com |
|
Source of Monetary or Material Support
|
All India Institute of Ayurveda Gautampuri Sarita Vihar New Delhi 110076 |
|
Primary Sponsor
|
Name |
All India Institute of Ayurveda |
Address |
All India Institute of Ayurveda Gautampuri Sarita Vihar New Delhi 110076 |
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 Pratik Bahute |
All India Institute of Ayurveda |
Room No. 725 Dept Of Panchakarma All India Institute of Ayurveda Gautampuri Sarita Vihar New Delhi 110076 South West DELHI |
9403261833
bahutepratik@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: E785||Hyperlipidemia, unspecified, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Haridradwaya choorna |
Haridradwaya choorna in the dose of 6gm orally twice a day for 30 days. |
Intervention |
Haridradwaya choorna with Vamana Karma |
Haridradwaya churna 6 grams orally twice a day before food for 30 days.
VAMANA- Vatsaka beeja churna-3gms
Madana phala pippali churna-3gms
Saindhav-3gms
Madhu- 40gms
Kovidar kashaya-2000 ml
(Bouhinia purpuria linn.)
Vamana Karma will be done by giving above drugs orally for 1 day.
Folloed by Samsarjana Karma as per Shoddhi for 3-7 days
(Specific dietetic schedule)
|
|
Inclusion Criteria
|
Age From |
25.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
Age group : Between 25 -60 years
serum cholesterol (201 mg/dl or more)
serum TGLs (161 mg/dl or more)
Screening
using inclusion and exclusion criteria
Diagnosis
Randomisation using CRT
On 31
th
day
FOLLOW UP
serum HDL (below 40 mg/dl)
serum LDL (131 mg/dl or more)
serum VLDL (41 mg/dl or more) will be included in the study. |
|
ExclusionCriteria |
Details |
1.Systemic illness which will interfere with the course of procedure.
2.Patients unfit for Vamana karma |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Other |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
Reduction in the levels of
1. Serum Cholesterol
2. Serum Triglycerides
3. Serum HDL
4. Serum LDL
5. Serum VLDL
|
1st and 30th day |
|
Secondary Outcome
|
Outcome |
TimePoints |
1. Improvement in dehabala, agnibala and chetasbala
2. Random Blood Sugar level
3. BMI
4. Waist to hip ratio
5. Reduction in body weight
6. Assessment of Dosha, Dhatu,And Mala |
1st day and 30th day |
|
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/ Phase 3 |
Date of First Enrollment (India)
|
01/07/2020 |
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
|
Nil |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
INTRODUCTION- Dyslipidemia is a disorder of lipoprotein metabolism which can include overproduction or deficiency of lipoprotein or both. The disorder can manifest as an elevation of plasma cholesterol ,triglyceride or both or a low level of high density lipoprotein or all three together that contributes to the development of atherosclerosis. As Dyslipidemia is metabolic disorder, It requires long term treatment and drug like statins are the first choice in the treatment of Dyslipidemia. The data from the US National Health and Nutrition Examination Survey conducted from 1999 to 2000 reported that 25% of adults either had total cholesterol >239.4 mg/dl or were taking a lipid-lowering medication. Lifestyle modifications should always be a part of the management of dyslipidemia. However, the need for long-term, lifelong therapy is associated with several adverse effects such as myopathy, increased risk of renal failure, hypothyroidism and memory loss in 15%-20% of the patients on treatment with statins. But the holistic approach of Ayurveda treatments seems to be safe and cost effective as it targets the route cause of the disease particularly by use of Panchakarma and natural medicine like herbs, hence the present study is planned. OBJECTIVES – PRIMARY: 1. To evaluate the efficacy of Vamana karma with Vatsak beeja choorna + Madana phala pippali choorna and Kovidar kashaya . 2. To compare the efficacy of Haridradwaya choorna with and without Vamana Karma in management of Sthoulya (dyslipidemia). SECONDARY: Reduction in symptoms of sthoulya like – Kshudhaadhikya pipasa aadhikya Gatradourgandhya Chala sphik-udara-stana Angagaurava Nidradhikya Gatra sadana Javoparodha Reduction in level of pathological parameter of Dyslipidemia viz. serum cholesterol, serum Triglycerides, serum HDL, serum LDL, serum VLDL . METHODOLOGY: STUDY TYPE – Interventional INTERVENTION METHOD – Parallel TIME PERSPECTIVE – Prospective MASKING - Open Label SAMPLE SIZE- 30 GROUPING - Two groups, Group A (15) & Group B(15). Duration- 30 days Followup- 31st days |