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Clinical Trials/CTRI/2024/11/077431
CTRI/2024/11/077431Not yet recruitingPhase 2/3

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

All India Institute of Ayurveda1 site in 1 country72 target enrollmentStarted: January 30, 2025Last updated:
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Trial Snapshot

Phase
Phase 2/3
Status
Not yet recruiting
Enrollment
72
Locations
1
Primary Endpoint
This study will provide information about efficacy of Yoga nidra and Nadi sodhana pranayama in the improvement AIS & quality of sleep.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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.

4o

Study Design

Study Type
Interventional
Allocation
Other
Masking
None

Eligibility Criteria

Ages
21.00 Year(s) to 50.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •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.

Exclusion Criteria

  • •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.

Outcomes

Primary Outcomes

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

Time Frame: after 30 days it will be assessed

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Dr Niral Priyadarshi

All India Institute of Ayurveda

Study Sites (1)

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