A Comparative Clinical Trial to Evaluate the Effect of Arjuna Twak Ksheerapaka and Cardio Tea in Pre Hypertension
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in Blood Pressure
研究概览
简要总结
Need of study**:** Pre-hypertension is one of the major public health problems among NCDs in developing countries, which increases cases of hypertension & chances of strokes from early ages.
Prevalence of Pre-hypertension is significantly higher than hypertension. In India about 23% are hypertensive while 38% are Pre-hypertensive.
• There is no requirement of medical intervention in pre-hypertension, the recommendations are only lifestyle modification, still there is further chance of developing hypertension.
• The development of hypertension may be prevented by controlling the condition of pre-hypertension by using Ayurvedic management, Arjuna Twak Ksheerapaka or Cardio Tea in daily routine.
• There are various evidences on the effect of Arjuna Twak Ksheerapaka on hypertension.
• Cardio Tea is a value-added version of Arjuna Twak Ksheerapaka prepared by NIA (DU), Jaipur which includes Twak, Ela, Shunthi and Mishreya along with Arjuna Twak to enhance the palatability (taste and flavour).
Aim and Objectives
Aim: To evaluate the Effect of Arjuna Twak Ksheerapaka and Cardio Tea in Pre-hypertension**.**
Objectives
Primary:To compare effect of Arjuna Twak Ksheerpaka and Cardio Tea in Pre-hypertension.
Secondary:To compare effect of Arjuna Twak Ksheerapaka and Cardio Tea on lipid profile.
Research Question
Primary: Is there any difference in the effect of Arjuna Twak Ksheerapaka and Cardio Tea in Pre-hypertension?
Secondary: Is there any difference in the effect of Arjuna Twak Ksheerapakaand Cardio Tea on lipid profile?
Null Hypothesis
H0 (1):There is no difference between the effect of Arjuna Twak Ksheerapaka and Cardio Tea in pre-hypertension.
H0 (2): There is no difference between the effect of Arjuna Twak Ksheerapaka and Cardio Tea on lipid profile.
Alternate Hypothesis (HA)
HA (1): There is Significant difference between the effect of Arjuna Twak Ksheerpaka and Cardio Tea in pre-hypertension.
HA(2): There is Significant difference between the effect of Arjuna Twak Ksheerapaka and Cardio Tea on lipid profile.
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
- 30.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Person between 30 to 70 years of age and irrespective of gender Person Pre-hypertensive having BP 120 to 139 mm of Hg systolic and or 80 to 89 mm of Hg Diastolic.
排除标准
- •Patients having any systemic and metabolic Diseases Patient with comorbidity affecting mental or physical health Abuse of drugs and alcohol addiction of tobacco Pregnancy and lactation.
结局指标
主要结局
Change in Blood Pressure
时间窗: Baseline and every two weeks till 12 weeks
次要结局
- Changes in Lipid Profile cholesterol LDL HDL VLDL triglycerides(12 weeks)
研究者
Dr Sarvesh Kumar Agrawal
National Institute of Ayurveda