Effect of selective acupuncture points on blood pressure in patients with Primary Hypertension- A Randomized controlled trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Systolic blood pressure (SBP) and Diastolic blood pressure (DBP) will be measured before and after the
研究概览
简要总结
Hypertension is known as high or raised blood pressure, is a condition in which the blood vessels have persistently raised pressure when systolic blood pressure (SBP) is ≥140 mmHg and/or the diastolic blood pressure (DBP) is ≥90 mmHg. The number of adults with hypertension in worldwide is predicted to reach 1.56 billion as prevalence by 2025.Acupuncture was one of the earliest and traditional methods of treatment for "hard pulse disease" (now called hypertension). This Randomized controlled trial study aims to evaluate the effect of selective acupuncture points on blood pressure in patients with primary hypertension .This study includes totally 60 participants both male and female. After obtaining informed consent, participants who fit to the inclusion criteria will be randomly allocated into GROUP A (study group ,n=30) GROUP B (control group, n=30) .GROUP A will receive selective acupuncture points at KI3, LIV2, SP10, LU9, alternate sides for 20 minutes once a day for 6 weeks (weekly thrice) along with their regular allopathic medications. GROUP B will be asked to sit for 20 minutes along with their regular allopathic medications. Assessment will be taken before and after the intervention. As a primary outcome the Systolic blood pressure (SBP) and Diastolic blood pressure (DBP) will be measured before and after the intervention using non-invasive Fully Automatic Digital Blood Pressure Monitor. As a secondary outcome Heart rate variability will be measured before and after the intervention of 6 weeks.
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 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Both male and female of age group 35 to 60 year who are under single drug or two drug combination having Blood pressure range between (systolic 140-159mm Hg) and (diastolic 90-99 mmHg) and who are willing to participate in study are included.
排除标准
- •Participants with Secondary Hypertension , Female participants during menstruation, pregnancy and lactation, Participants with mental illness , Needle phobia are excluded.
结局指标
主要结局
Systolic blood pressure (SBP) and Diastolic blood pressure (DBP) will be measured before and after the
时间窗: base line and 6th week
intervention using non-invasive Fully Automatic Digital Blood Pressure
时间窗: base line and 6th week
次要结局
- Heart rate variability will be measured before and after intervention(Base line & 6th week)
研究者
Dr S Mohanamathiyal
International Institute of Yoga and Naturopathy Medical sciences, Chengalpattu
