跳至主要内容
临床试验/CTRI/2020/03/023742
CTRI/2020/03/023742尚未招募2/3 期

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.

All India Institute of Ayurveda1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年1月7日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
入组人数
30
试验地点
1
主要终点
Reduction in the levels of

研究概览

简要总结

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

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
25.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 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.

排除标准

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

结局指标

主要结局

Reduction in the levels of

时间窗: 1st and 30th day

1. Serum Cholesterol

时间窗: 1st and 30th day

3. Serum HDL

时间窗: 1st and 30th day

4. Serum LDL

时间窗: 1st and 30th day

2. Serum Triglycerides

时间窗: 1st and 30th day

5. Serum VLDL

时间窗: 1st and 30th day

次要结局

  • 1. Improvement in dehabala, agnibala and chetasbala(2. Random Blood Sugar level)

研究者

申办方类型
Research institution and hospital

研究点 (1)

Loading locations...

相似试验