CTRI/2010/091/000368尚未招募3 期
A phase III, double blind, randomised, parallel design, controlled clinical study to assess and compare the lipid-lowering effects and safety of poly-herbal formulation "NARSIMHA" with Atorvastatin in hyperlipidemic men and women.
Nisarga Biotech Pvt Ltd1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Efficacy
研究概览
简要总结
A phase III, double blind, randomized, parallel design, controlled clinical study to evaluate the efficacy and safety of poly-herbal formulation "NARSIMHA" is undertaken in 80 hyperlipidemic patients of 30 to 70 years of age. The trial shall be conducted at: Deenanath Mangeshkar Hospital & Research Centre, Pune. Treatment will be given for 3 months. Atorvastatin shall be used as a comparator (active controlled) drug. Efficacy of the drug will be evaluated based on visits on day (-7), 45, 90 & 120.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 30.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •The subject of 30-70 years of age of either sex with established hyperlipidemia 2)Free of obvious health problems as established by medical history and physical examination.
- •The subject willing to give written informed consent and willing to comply with study protocol.
- •The subject not received lipid lowering drugs at least 3 months prior to recruitment.
排除标准
- •The subject with cardiovascular disease, diabetes mellitus, chronic inflammatory diseases, untreated hypertension (> 140/95 mm Hg) or liver/renal disease.
- •Subject participating in other clinical trial or planned participation in another clnical trial during the present trial period.
- •The Subject with H/o smoking or the subject receiving anti-inflammatory or lipid-lowering medication.
- •History of a previous severe allergic reaction (generalized urticaria; angioedema or anaphylaxix), chronic alcohol consumption and/or intravenous drug abuse.
- •Pregnant and lactating women.
- •History of contraceptive, harmone replacement therapy (HRT) or steroids since last 3 months.
- •Subjects with history of tuberculosis, HIV or malignancy.
结局指标
主要结局
Efficacy
时间窗: Measured on Day 1, 45, 90 & 120.
次要结局
- Safety(Measured on Day 1, 45, 90 & 120.)
研究者
研究点 (1)
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