CTRI/2022/03/040868进行中（未招募）3 期
A Clinical Study to evaluate the efficacy of Punica Granatum in Promotion of Cardiovascular Health
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- CSIR
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in Hs-CRP from 1st day i.e. baseline to 12th week.
研究概览
简要总结
I would like to publish my research trial after its completion as soon as possible. Patients will be studied in two groups i.e. trial group and control group. The outcome will be analyzed based on subjective and objective parameters with appropriate statistical tools.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Open Label
入排标准
- 年龄范围
- 20.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients who are willing to undergo for the treatment.
- •Age between 20 -70 years.
- •Pre-hypertensive patients (as per JNC VII Criteria) and impaired lipid profile.
排除标准
- •Hypertensive patients (SBP≥140mm of Hg and/or DBP≥90mm of Hg).
- •Patients with FBS>150mg/dl; PPBS > 200mg/dl; RBS > 250mg/dl.
- •Subjects with established diagnosis of CAD requiring any procedure in next 6 months – angioplasty or bypass surgery or subjects with New York Heart Association (NYHA) Classification Category III and IV cardiac insufficiency, or any other clinically significant cardiovascular disease.
- •Subjects with Haemoglobin percentage < 9 gm% for males and <8gm% for females.
- •Patients suffering from major systemic illness necessitating long term treatment (R.A., PTB, malignancy etc.).
- •Subjects with concurrent Hepatic Dysfunction (defined as AST and/or ALT > 3 times of the upper normal limit) Subject on systemic or oral steroids, oral contraceptive pills or estrogens replacement therapy.
- •Any other condition which the Investigator thinks may compromise the safety of the subject.
- •Pregnant/ lactating women.
- •Patients who have participated in any clinical trial during past 6 months.
结局指标
主要结局
Change in Hs-CRP from 1st day i.e. baseline to 12th week.
时间窗: 84 days
Change in functional capacity from 1st day i.e. baseline to 12th week.
时间窗: 84 days
Change in S. Lipid profile from 1st day i.e. baseline to 12th week.
时间窗: 84 days
Change in blood Pressure from 1st day i.e. baseline to 12th week.
时间窗: 84 days
次要结局
- Change in FBS and HbA1c from 1st day i.e. baseline to 12th week.(Change in Heart Rate from 1st day i.e. baseline to 12th week.)
研究者
研究点 (1)
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