A Randomized Clinical Study On Dyslipidaemia and Comparative Evaluation Of Unani Formulation With Rosuvastatin In Its Management
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Improvement in objective parameters
研究概览
简要总结
Disorders of lipoprotein metabolism are collectively referred to as “dyslipidaemia.â€Dyslipidaemias are generally characterized clinically by increased plasma levels of cholesterol, triglycerides, or both, variably accompanied by reduced levels of HDL cholesterol. The majority of patients with dyslipidemia have some combination of genetic predisposition (often polygenic) and environmental contribution (lifestyle, medical condition or drug).Increased levels of LDL cholesterol, remnant lipoproteins as well as decreased levels of HDL cholesterol have all been associated with an increased risk of premature vascular disease. Statins are considered first-line treatment for patients with dyslipidemia. Therapeutic benefits include plaque stabilization, improvement of coronary endothelial function,
inhibition of platelet thrombus formation, and anti-inflammatory activity. Adverse effects includes hepatotoxicity (dose related) with increase in serum transaminaselevels, headache, sleep disturbances, Myopathy- muscle pain & weakness with raisedplasma creatinine kinase activity, gastrointestinal- anorexia, nausea vomiting &diarrhoea.More serious adverse events are rare, but include rhabdomyolysis, hepatitis and
angioedema.The management of Saman-e-Mufrit is strenuous exercise, avoidance of fatty diet, excess use of vinegar, dalak-e-sulb, Hammam and specific drugs those have property to
reduce the weight. Unani system of medicine possess a large number of single and compound drugs, which are being used in the treatment of Saman-e-Mufrit like Muqil, LukMaghsool, Marzanjosh etc. To provide effective and safe treatment through Unani Medicine in Dyslipidemia, present study has been designed to validate the efficacy and safety of “Unani Formulationâ€which has been described in the well known unani pharmacopeia Byaz-e-khas.
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
- 30.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients in age group of 30-60 years Patients of either gender Patient willing to sign the written informed consent Clinically stable patients of dyslipidemia with following subjective and objective parameters Subjective parameters: Patient showing any one of the following symptoms will be asked to go for required investigations & will be included in the study accordingly.
- •Increasing body weight Dyspnoea on exertion Fatigue Xanthelasma Corneal arcus Joint pain Patients having any two of the following will be included in the study: Total Serum cholesterol ( 200-300 mg/dl) Serum triglyceride (160-300 mg/dl) LDL (130-190 mg/dl) HDL (30-60 mg/dl) LDL (30-50 mg/dl).
排除标准
- •Patient below 30 years and above 60 years Any uncontrolled systemic illness Any type of liver disease Patient of CAD Uncontrolled type 2 Diabetes Mellitus Hyperthyroidism and Hypothyroidism Pregnant and lactating women Alcoholic Patient who fails to give consent In case of worsening of symptoms patient may be withdrawn from trial and be shifted to standard treatment.
结局指标
主要结局
Improvement in objective parameters
时间窗: 90 days on monthly follow up
Objective assessment (Serum Total Cholesterol, LDL, HDL, VLDL, Serum
时间窗: 90 days on monthly follow up
Triglyceride)
时间窗: 90 days on monthly follow up
次要结局
- Improvement in subjective parameters(Subjective assessments Increasing body weight)
研究者
Md Hamza Ahmad
Ajmal Khan Tibbiya College Aligarh Muslim University Aligarh
