Immediate effect of acupuncture and moxibustion to GV8, GV9, GV10, GV11 on autonomic function in healthy individuals- a randomized controlled study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Pupillary light reflex will be assessed by using Dynamic Pupillometry
研究概览
简要总结
A randomized control study design will be adopted for this study. 100 participants will be recruited from Government Yoga and Naturopathy medical college and hospital and randomized into two groups of 50 namely study and control groups respectively. After baseline assessment of outcome variables, both groups will undergo their respective interventions, after which post-assessments will be made. The study group will receive acupuncture and moxibustion at four acupuncture points. The control group will not receive any intervention. The primary outcome variable is Reflex Latency (RL), Minimum Pupil Diameter (MPD), Baseline Pupil Diameter (BPD), Maximum Constriction Velocity (MCV), Maximum Redilation Velocity (MRV), Absolute Constriction Amplitude (ACA), Absolute Dilation Amplitude (ADA), Duration Of Constriction (DC) And Duration Of Dilation (Dd) will be assessed before and after the intervention by using Dynamic Pupillometry. the secondary outcome variable is Heart rate and Heart rate variability will be assessed before and after the intervention by using a 16-channel polygraph (BIOPAC MP160, 16-channel polygraph).
The values collected at baseline and immediately after intervention will be analyzed.
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
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •subject who are willing to participate in this study.
排除标准
- •Subjects who had systemic disorders (e.g. Cardiovascular system, Respiratory system, Renal system) Subjects who had Eye related disorders Subjects diagnosed with any mental illness Subjects have undergone hospitalization or surgery in the past 6 months Pregnancy and lactating women.
结局指标
主要结局
Pupillary light reflex will be assessed by using Dynamic Pupillometry
时间窗: Baseline will be assessed before intervention and Post assesssment will be taken immediately after intervention
次要结局
- Heart rate & Heart rate variability will be assessed before & after the intervention by using a 16-channel polygraph (BIOPAC MP160, 16-channel polygraph).(Heart rate & Heart rate variability will be assessed before & immediately after the intervention by using a 16-channel polygraph (BIOPAC MP160, 16-channel polygraph).)
研究者
M H VINOTHKUMAR
Government yoga and naturopathy medical college and hospital