Evaluation of the efficacy and safety of polyherbal formulation in mild to moderate hypertension : A randomized, double-blind, controlled clinical study
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Percentage of patients achieving blood pressure (B.P) less than 140/ 90 mm of Hg
研究概览
简要总结
It will be a 12-week interventional study with 60 participants with stage 1 essential hypertension. The participants will be randomly assigned equally in two arms. One group will receive Brahmi capsules, while the other group will receive a test drug. The efficacy and safety of both treatments will be compared. Efficacy will be evaluated based on the percentage of subjects achieving B.P. less than 140/90 mm of Hg, as well as changes in systolic blood pressure (SBP), diastolic blood pressure (DBP), and mean arterial pressure (MAP) from baseline to the end of the12 weeks. Safety will be assessed by recording adverse events from the baseline to the end of the 12-week study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Stage 1 Essential hypertension (average automated systolic blood pressure of 140 to 160 mmHg or diastolic blood pressure of 90 to 100 mm of Hg acc.
- •to JNC VIII).
排除标准
- •Atrial Fibrillation (AF)/ Sick Sinus Syndrome (SSS)/ atrioventricular block 2-3 grade without pacemaker.
- •Bradyarrhythmia
- •Unstable Angina Pectoris (UAP)/AMI/ HF (NYHA class III.
- •Uncontrolled diabetes mellitus (DM)
- •Gastro-intestinal ulcer
- •Liver dysfunction/ renal impairment
- •Treated with CCB (Calcium antagonists) or other beta blocker.
- •Pregnant or lactating women
- •Legal incapacity or limited legal capacity.
结局指标
主要结局
Percentage of patients achieving blood pressure (B.P) less than 140/ 90 mm of Hg
时间窗: Baseline and at 12 weeks
次要结局
- Changes in Systolic blood pressure, diastolic blood pressure, mean arterial pressure(baseline to 12 weeks)
- Safety will be assessed by recording adverse events (through 24 hours post-dose and at all follow-ups) and physical examination and vitals (Baseline to 12 weeks) along with the evaluation of LFT, and KFT.(baseline to 12 weeks)
- Assessment of change in the proportion of subjects with reduced doses of conventional treatment from screening to end of the study(baseline to 12 weeks)
- Change in eGFR (estimated glomerular filtration rate)(baseline to 12 weeks)
- Changes in Blood sugar levels, Lipid profile, BMI, Waist circumference of the patients and the Psychological and somatic wellbeing on the basis of Hamilton anxiety rating scale.(baseline to 12 weeks)
研究者
Dr Kshipra Rajoria
National Institute of Ayurveda Jaipur