CTRI/2025/05/087052尚未招募1 期
Randomised Open Controlled Clinical Study to evaluate the effect of Bruhatyadi Vati in management of Medodushti with special reference to Dyslipidema
DrNileshkumar Samarjit Tiwari1 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2025年1月7日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Changes in Lipid Profile by Bruhatyadi Vati towards the Normal levels.
研究概览
简要总结
Dyslipidemia is a major risk factor for cardiovascular disease, the leading cause of deaths.
Currently available Hypolipidemic drugs are either expensive or often related to side effects. Hence there has been a pursuit for new safe and effective polyherbal drug for Dyslipidemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 25.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Age group having 25 to 60 years of age.
- •Obese Dyslipidemic and Non-Obese Dyslipidemic Patients (BMI-18.50 to 40.00 kg/m2) as per latest Updated WHO classification of BMI).
- •According to NCEP ATPIII Classification, the Pilot Project Study by Prevalence in local area and with the guidelines of CCRAS for Dyslipidemia; following were 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 Patients having one or more of above levels will be selected for said project.
排除标准
- •Pregnant and lactating mothers.
- •Patients having Diabetes Mellitus.
- •Patients having history of Respiratory Disease Complications, Coronary Heart disease, Renal Disease Patients having Acute Complications like Severe Hypertension (B.P 150/90 mm Hg in those with age 60 years and older, and 140/90 mm Hg for adults less than 60 years.
- •according to Eighth Joint National Committee Guideline), Hepatitis or with history of major surgery etc.
- •Patients having disorders like Carcinoma anywhere in the body etc.
结局指标
主要结局
Changes in Lipid Profile by Bruhatyadi Vati towards the Normal levels.
时间窗: Outcome will be assessed at baseline, 4 weeks & 8 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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