A clinical study of an Ayurvedic formulation with and without Nidana Parivarjana in the management of Vyanabala Vaishamya w.s.r. to primary hypertension
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Changes in Systolic and Diastolic Blood Pressure.
研究概览
简要总结
Hypertension is a common lifestyle disorder andis a very strong risk factor for cardiovascular diseases(CVDs). It is estimatedthat it increase the risk at least two fold for CVDs including coronary arterydiseases(CAD).
Therefore to attain and to maintain good health, hypertensivepatients are looking towards Ayurveda. So it has become an importantduty ofAyurvedic research scholars and physicians to study the theoryof hypertension and to check out its proper mode of treatment.
AIM OF STUDY:
1. To study the effect of an Ayurvedic Formulation with and without nidana parivarjana in the management of vyanabala vaishamya w.s.r. to primary hypertension.
OBJECTIVE OF STUDY:
1. To study the etiopathogenesis, symptomatology of primary hypertension on the basis of
Ayurvedic principles.
Null hypothesis [Ho]:
· Trial drug (Ayurvedic Formulation)is equally effective with Nidana parivarjana than without Nidana parivarjana in the management of vyanabala vaishamya w.s.r. to primary hypertension.
Alternative hypothesis [H1]:
· There will be no difference between the effect of trial drug (Ayurvedic formulation) with Nidana parivarjana than without Nidana parivarjana in the management of vyanabala vaishamya w.s.r. to primary hypertension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 59.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients willing to sign the consent form for the clinical trial.
- •Patients belonging to either sex between the age group 18 to 59 years.
- •Patients having no known complication of disease.
- •Diagnosed case of stage-1 (Systolic B.P 140 to 159, Diastolic B.P 90 to 99 mm of Hg) would be selected for study (as per 8thJNC).
排除标准
- •Patients having secondary hypertension.
- •Patents having systemic/serious complications of Cardiovascular / Cerebrovascular / Renal system.
- •Pregnant patients.
- •Patients on Oral Contraceptive Pills.
- •History of liver disease in the recent past.
- •Hypertensive-Retinopathy
- •Patients who have completed participation in any other clinical trial drugs or their ingredients within one month period.
- •Patients who have received any Antihypertensive medication (Modern Drug) within last two weeks.
结局指标
主要结局
Changes in Systolic and Diastolic Blood Pressure.
时间窗: 31 days
次要结局
- Changes in Qualitative and Quantitative variables (Except Systolic and Diastolic Blood Pressure and ECG)(31 days)