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CTRI Number  CTRI/2024/11/077431 [Registered on: 27/11/2024] Trial Registered Prospectively
Last Modified On: 27/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Other (Specify) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Efficacy Of Yoga Nidra And Nadi Sodhana Pranayama In The Management Of Anidra- A Randomised Comparative Clinical Trial. 
Scientific Title of Study   Efficacy Of Yoga Nidra And Nadi Sodhana Pranayama In The Management Of Anidra- A Randomised Comparative Clinical Trial.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Niral Priyadarshi 
Designation  MD SCHOLAR 
Affiliation  All India Institute of Ayurveda 
Address  Room no.622 6th floor Department of Swasthavritta All India Institute of Ayurveda Sarita Vihar 110076

South
DELHI
110076
India 
Phone  7048732508  
Fax    
Email  223niral@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Medha Kulkarni 
Designation  Hod Department of Swasthavritta  
Affiliation  All India Institute of Ayurveda 
Address  Room no.622 6th floor Department of Swasthavritta All India Institute of Ayurveda Sarita Vihar 110076

South
DELHI
110076
India 
Phone  9890355305  
Fax    
Email  medha63@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Niral Priyadarshi 
Designation  MD SCHOLAR 
Affiliation  All India Institute of Ayurveda 
Address  Room no.622 6th floor Department of Swasthavritta All India Institute of Ayurveda Sarita Vihar 110076


DELHI
110076
India 
Phone  7048732508  
Fax    
Email  223niral@gmail.com  
 
Source of Monetary or Material Support  
Room no.622 6th floor Department of Swasthavritta All India Institute of Ayurveda Sarita Vihar 110076 
 
Primary Sponsor  
Name  All India Institute of Ayurveda 
Address  Room no.622 6th floor Department of Swasthavritta All India Institute of Ayurveda Sarita Vihar 110076 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Niral Priyadarshi  All India Institute of Ayurveda  Room no.622 6th floor Department of Swasthavritta All India Institute of Ayurveda Sarita Vihar 110076
South
DELHI 		 7048732508

223niral@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:G||Mental Health. Ayurveda Condition: NIDRANASAH/ASVAPNAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmLifestyle--Dinacarya: , Ritucarya: , Acara Rasayana:, Other:Nadi Sodhana pranayama twice per day for 15min in 8am & 8pm for 30 days, Pathya/Apathya:no, Pathya:, Apathya:
2Intervention ArmLifestyle--Dinacarya: , Ritucarya: , Acara Rasayana:, Other:yoga nidra for 30 min on 10 pm every day for 30 days., Pathya/Apathya:no, Pathya:, Apathya:
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  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 
 
ExclusionCriteria 
Details  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.
7.Pregnant/lactating mother, HIV positive cases 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
This study will provide information about efficacy of Yoga nidra and Nadi sodhana pranayama in the improvement AIS & quality of sleep.  after 30 days it will be assessed  
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   30/01/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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.
 
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