跳至主要内容
临床试验/CTRI/2023/11/059733
CTRI/2023/11/059733尚未招募2 期

Effect of selective acupuncture points on blood pressure in patients with Primary Hypertension- A Randomized controlled trial

Dr. S.Mohanamathiyal1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年11月20日最近更新:

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

发起方
Dr. S.Mohanamathiyal
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr S Mohanamathiyal

International Institute of Yoga and Naturopathy Medical sciences, Chengalpattu

研究点 (1)

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