Evaluation of Comparative efficacy of Pushkarmoola Ghan Vati versus Sarpagandha Ghan Vati along with Lifestyle Modifications in the Management of Stage-1 Hypertension - A Randomized Controlled Trial
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Reduction in systolic blood pressure (SBP)
研究概览
简要总结
Volunteers will be informed about the study protocol. Willing participants will be randomly selected as per a computer-generated table. Clinical research format will be prepared and validated prior the study. Approval will be taken from the IEC from MGACHRC, Salod (H ) Wardha and after selection, each participant will be tested individually and selected according to the selection criteria. They are divided into two groups. The trial is a Randomised Standard Control Equivalence Clinical Trial. It will include a 60-day treatment period and follow-up visits on the 10th and 20th days after treatment.
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
- 35.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients willing to participate with written informed consent.
- •Age between 35-55 years of either sex Subjects having Systolic blood pressure 130- 139 mmHg & Diastolic blood pressure between 80- 89 mmHg (Stage-1 hypertension as per ACC/AHA 2017 guidelines).
排除标准
- •Cases of major illness like cardiovascular disorders like cardiogenic shock, unstable angina, aortic stenosis, diabetes mellitus, and renal disorders.
- •Patients taking medication like glucocorticoids Pregnant and lactating women.
- •Patient on antihypertensive and diuretic drugs.
结局指标
主要结局
Reduction in systolic blood pressure (SBP)
时间窗: 8 weeks
Reduction in diastolic blood pressure (DBP)
时间窗: 8 weeks
Reduction in mean arterial pressure (MAP)
时间窗: 8 weeks
次要结局
未报告次要终点
研究者
Dr Pooja Umeshchand Singh
Mahatma Gandhi Ayurved College Hospital and Research Center