| CTRI Number |
CTRI/2025/02/080842 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
04/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Other |
|
Public Title of Study
|
Effects of Nadi-Shodhana Pranayama on psychological and biochemcial parameters in Adults |
|
Scientific Title of Study
|
Temporal and Dose Dependent Effects of Nadi-Shodhana Pranayama on Psycho-Biochemical Parameters in Adults |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jitendra Kumar Sharma |
| Designation |
Professor |
| Affiliation |
Indira Gandhi National Tribal Universtiy |
| Address |
Department of Yoga, Indira Gandhi National Tribal University
Shahdol
MADHYA PRADESH
484887
India |
| Phone |
|
| Fax |
|
| Email |
jitendra.sharma@igntu.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Khushbu Jain |
| Designation |
Assistant Professor |
| Affiliation |
Morarji Desai National Institute of Yoga |
| Address |
Morarji Desai National Institute of Yoga, 68 Ashoka road, New Delhi
Central
DELHI
110001
India |
| Phone |
9711506919 |
| Fax |
|
| Email |
asstprof-bchem@yogamdniy.nic.in |
|
Details of Contact Person
Public Query
|
| Name |
Prakhar Tyagi |
| Designation |
Research Scholar |
| Affiliation |
Indira Gandhi National Tribal University |
| Address |
Department of Yoga, Indira Gandhi National Tribal University
Shahdol
MADHYA PRADESH
484887
India |
| Phone |
8860007462 |
| Fax |
|
| Email |
yoga.prakhar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Morarji Desai Nationa Institute of Yoga, New Delhi |
|
|
Primary Sponsor
|
| Name |
Indira Gandhi National Tribal University |
| Address |
Lalpur, Amarkantak, Madhya Pradesh - 484887 |
| Type of Sponsor |
Other [Central University] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Morarji Desai National Institute of Yoga |
68 Ashoka Road, Near Gole Dak Khana, New Delih - 110001 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prakhar Tyagi |
Indira Gandhi National Tribal Univeristy |
Yoga Hall, Department of Yoga
Shahdol
MADHYA PRADESH |
8860007462
yoga.prakhar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC), Indira Gandhi National Tribal University, Amarkantak |
Approved |
| Institutional Ethics Committee, Morarji Desai National Institute of Yoga |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
The study is focused on the effects and feasibility of Nadi Shodhana Pranayama |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nadi Shodhana Pranayama |
Nadi Shodhana Pranayama is a breathing practice explained in various Yoga texts. One round of the practice includes -
-Inhalation through left nostril
-Internal breath retention
-Exhalation through right nostril
-External breath retention
-Inhalation through right nostril
-Internal breath retention
-Exhalation through left
-External breath retention
Initially the ratio of inhalation, internal breath retention, exhalation and external breath retention is 1:1:1:1 respectively. It will be slowly increased to 1:2:1:1, 1:2:2:1, 1:4:2:1 and ultimately 1:4:2:2.
|
| Comparator Agent |
NIL |
No intervention will be given to the control group. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1)Individuals with minimal or no previous experience in the practice of Nadi Shodhana Pranayama.
2)Mentally and physically fit individuals having no major physical or mental issues.
3)Individuals who provide informed consent.
4)Individuals willing to adhere to the assigned practice for the complete duration of study.
|
|
| ExclusionCriteria |
| Details |
1)Individuals with any kind of physical or psychological morbidity.
2)Individuals indulged in other activities such as Gym or Yoga.
3)Individuals who do not understand Hindi/English language.
4)Individuals who smoke or take any other addictive substance.
5)Individuals who have participated in a similar study in the last six months.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Thyroxine test,
2.Lipid profile test,
3.Body Mass Index,
4.Hip circumference,
5.Mid upper arm circumference,
6. WHO Quality of Life scale |
day 0
3 months
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Body Mass Index,
2.Hip circumference,
3.Mid upper arm circumference |
day 0
3 months
6 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
03/03/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="3"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Nadi Shodhana Pranayama is an essential yogic practice, known for its various benefits as described in ancient yogic texts. This study aims to evaluate the impact of this pranayama on healthy individuals,. The directional hypothesis of the study is that Nadi Shodhana Pranayama will have significant effects on the psycho-biochemical parameters of adults, potentially influencing their physiological and psychological well-being. Through this trial, we aim to assess the feasibility of incorporating this practice into daily life, as well as the time required to attain the different breathing ratios associated with the pranayama. This investigation seeks to provide a deeper understanding of the benefits and practical aspects of Nadi Shodhana Pranayama in contemporary settings |