Efficacy of Arjun Chal in Dyslipidemia: A Randomized Controlled Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 44
- 试验地点
- 1
研究概览
简要总结
Purpose: To Evaluate the Efficacy of Arjun Chal in Dyslipidemia
Design: Double Blind Randomized Placebo Controlled Study
Intervention: 44 diagnosed cases of dyslipidemia will be included in the study and randomly allocated into two equal groups. Written informed consent will be obtained from them. In the test group, Fine powder of Arjun Chal (3gm) will be given in capsule form daily in 2 divided doses; each capsule will contain 750mg of the test drug, for 6 weeks. Patients will be advised to continue their routine statin treatment. In the control group, a Placebo (roasted wheat flour) will be given in the same way as of the test group. Change in subjective parameters and blood pressure will be recorded on every follow-up. Changes in Lipid profile and liver enzymes will be recorded at baseline, and after 6 weeks of clinical trial. Both groups will be advised not to make any major changes in their dietary habits and physical activity during the clinical trial.
Main Outcome Measures:
Primary Outcomes: Changes in lipid profile (Serum Cholesterol, Serum triglycerides and LDL, VLDL, HDL).
Secondary Outcomes: Improvement in subjective parameters (Dyspnea, Fatigue or weakness, Chest pain, Palpitation)
Reduction in Systolic and Diastolic blood pressure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient aged 20 to 70 years of either sex 2)Confirmed diagnosis of Dyslipidemia (as per NCEP ATP III guidelines) Total cholesterol 200-250 mg per dL, or LDL-C 130-189 mg per dL, or HDL-C less than 40 mg per dL and more than 60 mg per dL, or Triglycerides 150-499 mg per dL 3)Subjects on statins 4)Controlled Diabetes and Hypertension.
排除标准
- •Pregnant and lactating women 2)Secondary causes of hyperlipidemia (example Hypothyroidism, nephrotic syndrome, uncontrolled diabetes) 3)History of Cardiovascular events (recent myocardial infarction, congenital heart disease or rheumatic heart disease, stroke, or unstable angina within the past 6 month) 4)Hepatic or renal failure or disease 5)Uncontrolled hypertension (SBP more than 160mmHg or DBP more than 100 mmHg) despite treatment 6)Poorly controlled diabetes (FBS more than 130mg per dL) 7)A medical condition that in the investigator opinion would interfere with treatment, safety or adherence to the protocol.
研究者
Dr Ansari Ambareen Ansari Mohammad Javeed
National Institute of Unani Medicine Kottigepalya Magadi Main Road Bangalore Karnataka