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临床试验/CTRI/2024/11/077431
CTRI/2024/11/077431尚未招募2/3 期

Efficacy Of Yoga Nidra And Nadi Sodhana Pranayama In The Management Of Anidra- A Randomised Comparative Clinical Trial.

All India Institute of Ayurveda1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2025年1月30日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
入组人数
72
试验地点
1
主要终点
This study will provide information about efficacy of Yoga nidra and Nadi sodhana pranayama in the improvement AIS & quality of sleep.

研究概览

简要总结

Research Question: Is there a difference between Yoga Nidra and Nadi Shodhana Pranayama on the Athens Insomnia Scale (AIS) in patients with Anidra?


Hypotheses

  • Null Hypothesis (H0): No difference exists between Yoga Nidra and Nadi Shodhana Pranayama in improving AIS in Anidra patients.
  • Alternate Hypothesis (H1): There is a difference between Yoga Nidra and Nadi Shodhana Pranayama in improving AIS in Anidra patients.

Introduction

  • Sleep (Nidra) is one of the three pillars of life in Ayurveda, vital for maintaining health.
  • Anidra (insomnia) is a psychosomatic condition caused by stress, poor lifestyle, and other factors, leading to impaired quality of life.
  • Ayurveda describes imbalances in Tarpaka Kapha, Sadhaka Pitta, and Prana Vayu as the cause of Anidra.
  • Yoga Nidra is a meditative technique offering mental and physiological relaxation, while Nadi Shodhana Pranayama (a breathing practice) improves stress levels, emotional stability, and sleep.

Need for the Study

  • Insomnia affects a large portion of the population and is often managed with sedative drugs, which can have side effects.
  • Non-pharmacological, natural interventions like Yoga Nidra and Nadi Shodhana provide a safer and sustainable approach to managing insomnia.

Objective

  1. Primary: Compare the effects of Yoga Nidra and Nadi Shodhana Pranayama on improving AIS.
  2. Secondary: Enhance the quality of sleep and life in Anidra patients.

Literature Review

  • Yoga Nidra improves sleep patterns, reduces stress, and enhances physiological rest.
  • Nadi Shodhana Pranayama promotes emotional stability, reduces anxiety, and calms the nervous system.
  • Previous research supports the effectiveness of both interventions in improving sleep quality and mental health.

Study Design

  • Type: Clinical, prospective study.
  • Sample Size: 36 participants per group (72 total).
  • Groups:
  • Group A: Yoga Nidra (30 minutes daily at 10 PM).
  • Group B: Nadi Shodhana Pranayama (15 minutes, twice daily at 8 AM and 8 PM).
  • Duration: 30 days with a follow-up after 15 days.

Outcome Measures

  • Primary Outcome: Change in Athens Insomnia Scale (AIS) scores.
  • Secondary Outcome: Improvement in sleep quality and overall quality of life.

Data Analysis

  • Categorical variables: Summarized with frequency and percentages.
  • Quantitative variables: Analyzed using mean, SD, or non-parametric methods as appropriate.
  • Tests: Paired t-test, Wilcoxon rank test, and unpaired t-test.
  • Software: SPSS and EZR.

Techniques and Interventions

  1. Yoga Nidra: Guided meditation based on a recorded script, including body relaxation, breath awareness, and visualization.
  2. Nadi Shodhana Pranayama: Alternate nostril breathing performed in a structured manner.

Expected Outcomes

  • Insight into the comparative effectiveness of Yoga Nidra and Nadi Shodhana Pranayama in managing Anidra.
  • Recommendations for safer, non-invasive treatments for insomnia.

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研究设计

研究类型
Interventional
分配方式
Other
盲法
None

入排标准

年龄范围
21.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients of the age group between 21 to 50 years irrespective of gender, caste, religion, etc.
  • 2.Patients having different types of disturbed sleep patterns e.g. sleep onset insomnia, sleep maintenance insomnia, and nocturnal awakening.
  • 3.Patients with the chronicity of Anidra of atleast 3 months.

排除标准

  • 1.Patients on hypnotic medicine or other drugs known to cause drowsiness.
  • 2.Patients suffering from any chronic metabolic disorder.
  • 3.Taking treatment for any psychiatric issues.
  • 4.Subjects on systemic or oral steroids.
  • 5.Patients with alcohol or drug dependency.
  • 6.patients suffering from fatal familial insomnia.

结局指标

主要结局

This study will provide information about efficacy of Yoga nidra and Nadi sodhana pranayama in the improvement AIS & quality of sleep.

时间窗: after 30 days it will be assessed

次要结局

未报告次要终点

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Niral Priyadarshi

All India Institute of Ayurveda

研究点 (1)

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