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临床试验/CTRI/2024/05/067587
CTRI/2024/05/067587已完成2 期

Clinical evaluation of the time effect relationship of auriculoacupuncture at point zero on autonomic function among healthy volunteers

Dr D Annamalai1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年6月1日最近更新:

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
90
试验地点
1
主要终点
The primary outcome will determine the effectiveness of acupuncture in eliciting parasympathetic activation based on changes in heart rate variability.

研究概览

简要总结

Auriculotherapy (Part of Acupuncture) has been utilized in Traditional Chinese Medicine (TCM) for both diagnosis and treatment. According to TCM, the ear is believed to be directly connected with the 12 meridians.Dr. Paul Nogier introduced an ear diagrammatic chart in 1957, representing an inverted fetus, which was subsequently approved by the World Health Organization (WHO).In 2009, Dr.Romoli and Mazzoni updated this chart into a sectogram, incorporating auriculotherapy points that extend outward from the root of the helix, known as Point Zero. The practice of acupuncture depends on several factors like type of needle, frequency, technique, manual acupuncture, electrical acupuncture, disease and particularly duration of needle retention makes it difficult for clinical practice. The duration of acupuncture treatment has not been paid attention on clinical research so  this study focuses on investigating the effects of needle retention period on auriculotherapy at Point Zero. Healthy volunteers of age group between 18- 40 years with BMI (18-25 kg/m2). After screening of healthy volunteers ,they will be divided into 3 different groups, each group will have n=30 subjects called Arm 1, Arm 2, Arm 3. Participants of Arm 1(n=30) will receive acupuncture at Point zero with Press needle(3×3mm) for a duration of 5 minutes, Arm 2(n=30) participants will receive the same procedure for 30 minutes and participants of Arm 3 will receive the same procedure for 60(n=30) minutes.  As a primary outcome, HRV will be assessed on baseline and after 5/30/60 minutes. As a secondary outcome, PEFM ( Peak Exploratory Flow Meter) will be assessed on baseline and after 5/30/60 minutes.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
All

入选标准

  • Healthy volunteers with BMI less than 25 kg/m2 and who are willing to participate.

排除标准

  • Individuals with open wound in the ear, extensive ear rings, previously diagnosed of psychiatric disease , presence of neurological and cardiac disease, individual under addictions of alcohol , drugs and smoking.

结局指标

主要结局

The primary outcome will determine the effectiveness of acupuncture in eliciting parasympathetic activation based on changes in heart rate variability.

时间窗: ONLY BASELINE AND 5 MINUTES/30 MINUTES/60 MINUTES

次要结局

  • Mini-Wright’s Peak expiratory flowmeter has been used a standard method for Peak expiratory(flow rate will be determined before and after the study and record the changes.)

研究者

发起方
Dr D Annamalai
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr D Annamalai

International Institute Of Yoga and Naturopathy Medical Sciences

研究点 (1)

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