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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  
Name  Address 
Nil  Nil 
 
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  
Status 
Not Applicable 
 
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

 

 
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