| CTRI Number |
CTRI/2022/03/041417 [Registered on: 28/03/2022] Trial Registered Prospectively |
| Last Modified On: |
13/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Sudarshan Kriya Yoga(SKY) on inflammatory and hematological parameters among healthcare workers |
|
Scientific Title of Study
|
Effect of Sudarshan Kriya Yoga(SKY),a rhythmic breathing technique on inflammatory markers and various hematological parameters among healthcare workers |
| Trial Acronym |
SKY |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ArchanaB |
| Designation |
Assistant Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Pathology,1st floor,MedicaL College building,SRMC,Porur,Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
09840392807 |
| Fax |
|
| Email |
archanab@sriramachandra.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Archana B |
| Designation |
Assistant Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Pathology,1st floor,Medical College building,SRMC,Porur
Chennai
TAMIL NADU
600116
India |
| Phone |
09840392807 |
| Fax |
|
| Email |
archanab@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
ArchanaB |
| Designation |
Assistant Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Pathology,1st floor,SRMC,Porur,Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
09840392807 |
| Fax |
|
| Email |
archanab@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| Department of Pathology,Sri Ramachandra Medical College,Chennai |
|
|
Primary Sponsor
|
| Name |
Archana |
| Address |
Department of Pathology,SRIHER,Chennai |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Archana |
Sri Ramachandra Medical College |
Department of Pathology,1st floor,Medical College building,SRMC,Porur,Chennai 600116
Chennai
TAMIL NADU |
09840392807
archanab@sriramachandra.edu.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee |
Approved |
| Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Normal |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Sudarshan Kriya Yoga |
1)Ujjayi breath pranayama- 3 stages,8 cycles each.
2)Each cycle consisting of breathing in for 4 counts, holding the breath for 4 counts, breathe out for 6 counts and holding for 2 counts.
3)Bhastrika pranayama- 20 times,3 rounds each Sudarshan Kriya(rhythmic breathing) Counts of 20-40-40 with varying rhythms for 3 cycles
4)Rest for 10minutes.
Frequency-180minutes/week
Duration-12weeks
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Age of 25-45years, health care workers, practicing mild to moderate physical exercise(IPAQ questionnaire), not regularly practicing any yoga/relaxation techniques, no alcohol, no smoking and free from acute infection(past 2 weeks) |
|
| ExclusionCriteria |
| Details |
Absence of underlying medical conditions like obesity, diabetes, cardiovascular disease, inflammatory conditions, asthma, pregnancy (antepartum and post-partum(6months), psychiatric problems, those on health supplements or severe form of exercises. |
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
The total counts along with ESR,serum cortisol,RBS,CRP would be recorded.
CD4, 8,56 counts for flow cytometric analysis ,CD4:8 ratio would be estimated.
Production of IFN gamma will be assayed.
The IL-6(Proinflammatory cytokine), IL-4(anti-inflammatory cytokine) assays would be performed using ELISA
|
Assessments would be done at Day 0 and 12weeks
|
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
Sleep quality,DASS scoring,satisfaction with life,CD RISC scoring for wellness,
HRV & PFT |
Baseline & 12weeks |
|
Target Sample Size
Modification(s)
|
Total Sample Size="138"
Sample Size from India="138"
Final Enrollment numbers achieved (Total)= "138"
Final Enrollment numbers achieved (India)="138" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
11/04/2022 |
| Date of Study Completion (India) |
30/07/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Balasubramanian A, Nagarajan P, Chandrasekar MD, Udupa K, Bhaskar E, Kanchibotla D, Subramanian S. Effect of a Yogic Breathing Technique on Immune Parameters among Healthcare Workers: A Randomized Controlled Pilot Study. Traditional and Integrative Medicine. 2024 Dec 29 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Sudarshan Kriya is a very effective breathing technique.Though few studies have assessed the immune cell counts in SKY practitioners,not many studies have assessed the immune function status.Similarly,inflammation is said to reduce in SKY practitioners, thereby lower incidence of inflammation associated diseases are said to occur.We also would assess the mental health including depression,anxiety,stress,sleep and life satisfaction among health care workers who practice SKY regularly. |