Efficacy of Unani formulation in Dyslipidemia-An open labelled interventional clinical trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Effects on TGL, HDL, LDL, VLDL, TC (normal/decrease).
研究概览
简要总结
The dyslipidaemia is a state of abnormal levels of lipids (e.g. triglycerides, cholesterol and/or fat Phospholipids) in the plasma1. It is characterised as hypercholesterolemia, low level of high density of
lipoproteins (HDL) and triglyceridemia.
Dyslipidemia is the major risk factor for the cardiovascular disease and is estimated to cause 2.6 million death and 29.7 million disability adjusted life year’s globally. According to the World Health Organisation, the prevalence of dyslipidemia in the south east Asia (30%), and the western pacific (36.7%) were much lower than that in Europe (53.7%) and the Americas (47.7%). However, the prevalence of it across the Asia pacific region varies.If dyslipidemia not monitored and left untreated, affects the overall health status of an individual which may lead to overall hardening of the arteries in the later years of life. Similarly atherosclerosis is a condition described in conventional medicine occurs due to excess deposition of lipids in vessels and finally it can lead to MI and sudden death.
Multiple epidemiologic studies have demonstrated a strong relationship between plasma levels of LDL-C and CHD. A direct connection between plasma cholesterol levels and the atherosclerotic process was made in humans.In modern system of medicine, the dyslipidemia is treated by following ways: Life style modification, exercise, diet, revascularisation and medication. Statins are the cornerstone of lipid lowering treatment. Several different types of statins with different pharmacological structures are now available as well as other lipids lowering drugs, plasma lipids levels, particularly those of LDL often are not optimally lowered to reach the recommended levels
Keeping this view, the adverse effects of statins, various experts of different fields are exploring the methods to control the effects of lipids abnormalities. In Unani System of Medicine various formulation has been indicated for the condition like dyslipidemia. The management is described under the caption of dasoomat-e-dam, therefore principle of treatment of dyslipidemia given on the same line of treatment of dasoomat-e-dam. The Unani formulation constitute following drugs which will be given in the form of powder*: Badyan, Zeerakirmani, Bora armani, Suddab, Marzanjoshkhushk, Lukmaghsool, Nankhwah.*
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 20.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •ïƒ˜BMI between 25-35 kg/m2 A) LDL-cholesterol:130-159mg/dl(Borderline high)8 B)Totalcholesterol:200-239mg/dl(Borderline High)8 C)HDL-cholesterol:<40mg/dl(low) &>60mg/dl(High)8 D)Serum Triglycerides:200-499mg/dl(High)8 Patient who will give consent and able to do follow up.
排除标准
- •Patient below the age of 20 years and above the age of 55 years
- •Pregnant and lactating mothers
- •Patient with systemic illness such malignancy, liver, kidney dysfunction, T.B. etc.
结局指标
主要结局
Effects on TGL, HDL, LDL, VLDL, TC (normal/decrease).
时间窗: 0th day and 42nd day
次要结局
- BMI, Waist Circumference, Hip and Waist Ratio, Weight in Kgs(0th day, 14th day, 28th day, 42nd days.)