To see the effect of Haridradwaya Churna with andwithout Vamana Karma in trating Sthaulya (Dyslipidemia).

Phase 2/3

Not yet recruiting

• Conditions: Hyperlipidemia, unspecified,

• Registration Number: CTRI/2020/03/023742
• Lead Sponsor: All India Institute of Ayurveda

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 (d*yslipidemia).

 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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-07
• Last Update Posted: 2020-02-03

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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.

Exclusion Criteria

• 1.Systemic illness which will interfere with the course of procedure.
• 2.Patients unfit for Vamana karma.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in the levels of	1st and 30th day
1. Serum Cholesterol	1st and 30th day
3. Serum HDL	1st and 30th day
4. Serum LDL	1st and 30th day
2. Serum Triglycerides	1st and 30th day
5. Serum VLDL	1st and 30th day

Secondary Outcome Measures

Name	Time	Method
1. Improvement in dehabala, agnibala and chetasbala	2. Random Blood Sugar level

Trial Locations

Locations (1)

All India Institute of Ayurveda; 🇮🇳 West, DELHI, India

All India Institute of Ayurveda

🇮🇳West, DELHI, India

Dr Pratik Bahute

Principal investigator

9403261833

bahutepratik@gmail.com