| CTRI Number |
CTRI/2025/08/092467 [Registered on: 06/08/2025] Trial Registered Prospectively |
| Last Modified On: |
05/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Integrated Yoga Therapy for Chronic Low Back Pain Management
|
|
Scientific Title of Study
|
Effect of IAYT and Awareness Session on the Pain, Sleep Quality, Stress, and Quality of Life of Chronic Low Back Pain Participants |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sneha Rawat |
| Designation |
MSc student |
| Affiliation |
Swami Vivekananda Yoga Anusandhana Samsthana (S-VYASA) |
| Address |
Swami Vivekananda Yoga Anusandhana Samsthana (S-VYASA)
Division of Yoga & Life science
Research Department
Vivekananda Road
Kallabalu(Post)
Jigani
Bengaluru-560105
Bangalore Rural
KARNATAKA
560105
India |
| Phone |
9667638519 |
| Fax |
|
| Email |
snehar9723@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Nair |
| Designation |
Asst. Professor |
| Affiliation |
SVYASA |
| Address |
Swami Vivekananda Yoga Anusandhana Samsthana (S-VYASA)
Division of Yoga & Life science
Research Department
Vivekananda Road
Kallabalu(Post)
Begaluru
Bangalore Rural
KARNATAKA
560105
India |
| Phone |
9632164777 |
| Fax |
|
| Email |
rajeshnair@svyasa.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajesh Nair |
| Designation |
Asst. Professor |
| Affiliation |
SVYASA |
| Address |
Swami Vivekananda Yoga Anusandhana Samsthana (S-VYASA)
Division of Yoga & Life science
Research Department
Vivekananda Road
Kallabalu(Post)
Begaluru
KARNATAKA
560105
India |
| Phone |
9632164777 |
| Fax |
|
| Email |
rajeshnair@svyasa.edu.in |
|
|
Source of Monetary or Material Support
|
| SVYASA
Arrogyadhama Hospital |
|
|
Primary Sponsor
|
| Name |
SVYASA university Hospital |
| Address |
Swami Vivekananda Yoga Anusandhana Samsthana (S-VYASA)
Bengaluru 560105 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Amit Singh |
Arogyadhama - Holistic Research Health Home |
Room: E-section
Division of Yoga & Lifescience
Research Department
Prashanti Kutiram
Kallubalu Post
Jigani
Bangalore Rural
KARNATAKA |
080-22639963
arogyadhama@svyasa.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) - SVYASA |
Approved |
| Institutional Ethics Committee (IEC) - SVYASA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M472||Other spondylosis with radiculopathy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Integrated yoga therapy and awareness session |
Specific Asanas, Pranayama, Meditation techniques and awareness sessions. Full-day programme in a staggered manner
for 2 weeks |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Subjects, male and female, identified with CLBP
Age: 30 to 65 years
Subjects consenting to participate in the study.
|
|
| ExclusionCriteria |
| Details |
Subjects having any other severe health issues that interfere with the yoga practices
Subjects having any serious accident history
Subjects having issues with alcoholism or smoking
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Low Back Pain
Sleep quality
Stress
Quality of life
|
Baseline, and at the end of 2 weeks
Quality of life
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| BMI |
Baseline & at the end of 2 weeks of intervention |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
22/09/2025 |
| 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="0"
Days="14" |
|
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [snehar9723@gmail.com ].
- For how long will this data be available start date provided 10-11-2025 and end date provided 10-11-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
In this single arm design study, we intend to assess the efficacy of integrated yoga therapy program along with awareness session on the pain, sleep quality, perceived stress and quality of life of chronic low back pain participants. Participants (n=60) meeting the inclusion and exclusion criteria will be recruited for this study. Intervention will be provided by certified and trained yoga therapist/ Intervention duration will be for 2 weeks duration. |