Evaluating the Efficacy of Rookshana Purvaka Basti Karma with Varunadi Niruha and Ardhamatrika on Dyslipidemia - A randomized comparative clinical trial focused on Inflammatory and Lipid biomarkers
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- a)lipid profile that includes serum total cholesterol, serum triglycerides, serum HDL, serum LDL & serum VLDL.
研究概览
简要总结
Dyslipidemia is an extremely important condition, principally because of its contribution to atherogenesis and it is an independent and modifiable risk factor for CAD. Incidence of dyslipidemia is increasing in many developed and developing countries mainly due to westernization of diet and sedentary lifestyle
According to the ICMR–INDIAB Study, over three-fourth (79%) of the general adult population covered in the survey have abnormalities in at least one of the lipid parameters with no urban rural difference. Even the youngest age group has high rates of dyslipidemia.
The prevalence of dyslipidemia [as defined by National Cholesterol Education Program (NCEP) guidelines] in Indians is very high, with 79% of subjects having at least dyslipidemia, 72.3% subjects had high cholesterol in the high-density lipoprotein (HDL-C) level, 29.5% of subjects had hypertriglyceridemia and 11.8% of subjects had elevated low-density lipoprotein cholesterol (LDL-C).
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.
According to Madhava nidana, Medoroga nidana adhyaya and Charaka Samhita sutrasthana, Santarpaneeya adhyaya, the sign and symptoms of Medo vriddhi or Medo dushti have striking similarities with the disease Dyslipidemia. It can be classified as medo roga under Santarpanajanya vyadhi based on the etiological components and symptom complexes. Chikitsa sutra of Santarpana vyadhi primarily comprises of Apatarpana chikitsa. Basti appears to best among all the treatment modalities under Samshodhana chikitsa. Since it is the fastest Apatarpana Chikitsa that can eliminate excessively vitiated Kapha-medo dhatu by virtue of its lekhana and Doshanirharana karma.
Even rukshana karma, one among apatarpana chikitsa, especially Udwartana play a key or important role in the management of Dyslipidaemia by virtue of its Kapha hara and Vilayana karma / liquification of dushita medo dhatu. Considering all the above factors, here an attempt has been made to critically evaluate the efficacy of Rookshana Purvaka Basti Karma with Varunadi Niruha and Ardhamatrika on dyslipdemia, focusing on inflammatory and lipid bio marker.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients willing for trail, is the first & foremost criteria. Subjects between the age group of
- •50 years irrespective of gender, religion, occupation and socioeconomic status. Abnormal serum lipid levels like Total cholesterol (200 mg/dl or more) , serum triglycerides (150 mg/dl or more), serum HDL (below 40 mg/dl) , serum LDL (130 mg/dl or more), and serum VLDL (30 mg/dl or more) . Patient having one or any of these. Having the clinical features of Dyslipidemia. Subjects fit for Basti Karma. Patients of Dyslipidemia with Controlled Hypertension, Controlled Hypothyroidism and Controlled diabetes mellitus.
排除标准
- •Subjects below 20 years and above 50 years of age.
- •Subjects unfit for Basti Karma.
- •Patients with Angina, myocardial infraction, stroke, transient ischemic attack, heart and vascular surgery or major operations within 6 months prior to screening visit.
- •Patient with a history or evidence of systemic disorders like Cardiac, hepatic, renal & neurological diseases.
- •Diseases including Uncontrolled Diabetes mellitus, Liver Cirrhosis, Uncontrolled Hypothyroidism, Uncontrolled Hypertension & other malignancy.
- •Pregnant and lactating women.
结局指标
主要结局
a)lipid profile that includes serum total cholesterol, serum triglycerides, serum HDL, serum LDL & serum VLDL.
时间窗: Baseline, Day 7, Day 23
b)Inflammatory Bio markers that includes CRP, Interleukin (IL)-6, Serum ferritin, ESR
时间窗: Baseline, Day 7, Day 23
c)Lipid bio markers that includes Apolipoprotein B
时间窗: Baseline, Day 7, Day 23
d)Other Objective parameters are body weight in Kg, BMI ( Body Mass index ), SGOT, SGPT
时间窗: Baseline, Day 7, Day 23
次要结局
- a)Fatigue(b)Chest Discomfort)
研究者
Dr Dibyajyoti Moharana
Parul Institute of Ayurveda, Parul University