Therapeutic effect of Siddha medicine in hypertension patients – a Randomized Control Trial in government Primary Health Center, Tamil Nadu
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 198
- 试验地点
- 1
- 主要终点
- 4.7)Outcome measure: BP measurement as per the 2020 International Society of Hypertension guidelines. Then, Lab Investigation before and after treatment.
研究概览
简要总结
Venthamarai chooranam(VMC), a polyherbal Siddha medicine was studied in animal model about its potential therapeutic effect on hypertension and found VMC potentially interacts with renin-angiotensin components and endothelial functions, and thereby exerts its antihypertensive action . A Review article - Phytochemical Profile and Biological Activity of Nelumbo nucifera elucidates the various scientific experiments conducted on Nelumbo nucifera . The dissertation research work of Siddha PG scholar also demonstrates the safety and therapeutic effect in animal models . The Siddha Medicine Venthamarai Choornanam is a time-tested medicine and is being prescribed for hypertension patients. It is well tolerated and would provide holistic benefit to the patient.
With this background, a clinical research in the form of Randomised Control Trial(RCT) is proposed to determine the thereaputic effect of Venthamarai Choornam on Grade-1 hypertension as measured by 2020 International
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 25.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •â®šAge: 25-70 years ⮚Sex: Both male & Female ⮚Weight: 40-100 kgs ⮚Patients of Hypertension having – Grade 1, BP Systolic 140-159 mm Hg and Diastolic 90-99 mm Hg (Patients who have not taken any medicine for more than 30 days or newly diagnosed patients).
排除标准
- •â®šSecondary Hypertension with any organ damage like retinopathy or renal dysfunction, ⮚H/o.
- •CVD ⮚Orthostatic Hypotension ⮚Hypertension in Pregnancy ⮚Hypertension associated with Stroke, Ischemic heart disease ⮚Drugs (NSAIDS, Oral contraceptive pills) ⮚Alcohol abuse.
结局指标
主要结局
4.7)Outcome measure: BP measurement as per the 2020 International Society of Hypertension guidelines. Then, Lab Investigation before and after treatment.
时间窗: 0, 90 days
4.8)Primary outcome: BP – Quantified measurement
时间窗: 0, 90 days
次要结局
- Laboratory parameter (Quantitative / Qualitative data)(0, 90 days)