A Randomized controlled clinical study to assess the efficacy of Marichadi Vati (Combination of Maricha, Vidanga, Musta with Guggulu) in management of Medodushti with special reference to Dyslipidemia.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- with Guggulu)” in “Medodushti” with special reference to Dyslipidemia.
研究概览
简要总结
Objective- To observe the effect of ‘Marichadi Vati’on Lipid Profile over a period of 8 weeks. To compare the effect of "Marichadi Vati’ and tab. Atorvastin in "Medodushti" with special reference to Dyslipidemia; Design-Randomized controlled clinical trial; Methodology-Marichadi vati (Maricha, Vidanga, Musta and purana gugglu in 1:1:1:3 ratio, 1 gm BD before meal for 8 weeks, tab. Atorvastatin 10 mg HS for 8 weeks, Patients will be screened clinically every week and lipid profile will be repeated every month; Subjective criteria- Shwasa, nidra, Ayasa-akshamata, Jadya, alpabala; Objective criteria- lipid profile observed over 0,4& 8 weeks and graded as mentioned in the synopsis; Statistical considerations-to evaluate the efficacy of trial drug and control drug in numerical data, ’Paired t-test’ will be applied, to compare the efficacy of traial drug and control drug in ordinal data, ’Unpaired t-test’ will be applied, level of significance p<0.05
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To
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 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Obese Dyslipidemic and Non-obese Dyslipidemic Patients (BMI-18.50 to 40.00kg/m2) as per latest updated WHO classification of BMI.
- •According to NCEP ATP classification, the pilot project study by prevalence in local area and with the guidelines of CCRAS for Dyslipidemia; following are the levels to be selected for said project.
- •Patient having Serum Total Cholesterol Level 200-239 mg/dl.
- •Patient having Serum LDL Cholesterol Level 130-159 mg/dl.
- •Patient having Serum VLDL Cholesterol Level 40-60 mg/dl.
- •Patient having Serum HDL Cholesterol Level 20-40 mg/dl.
- •Patient having Serum Triglyceride Level 150-190 mg/dl.
排除标准
- •Pregnant and Lactating mothers.
- •Patients having Diabetes Mellitus.
- •Patients having history of Respiratory Diseases, Coronary Heart Diseases, Renal Diseases etc.
- •Patients having acute complications like Hypertension (BP- 150/90 mm of Hg in those with age 60 and older;and 140/90 mm of Hg for adults less than 60 yrs (According to Eight joint National Committee Guideline) 5) Patients having Hepatitis.
- •Patients having disorders like Carcinoma anywhere in the body etc.
结局指标
主要结局
with Guggulu)” in “Medodushti” with special reference to Dyslipidemia.
时间窗: For 8 weeks
To study the clinical efficacy of “Marichadi Vati (Combination of Maricha, Vidanga, Musta
时间窗: For 8 weeks
次要结局
- 1. To observe the effect of ‘Marichadi Vati (Combination of Maricha, Vidanga,(Musta with Guggulu) ’on Lipid Profile.)
研究者
Dr Harish Digambar Raut
R.A. Podar hospital, worli