| CTRI Number |
CTRI/2017/11/010597 [Registered on: 23/11/2017] Trial Registered Retrospectively |
| Last Modified On: |
20/10/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of yoga therapy on lung function and quality of life in patients with COPD |
|
Scientific Title of Study
|
Effect of adjuvant yoga therapy on pulmonary function and quality of life among patients with COPD: a randomized control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Artchoudane S |
| Designation |
M.Phil Yoga therapy (Student) |
| Affiliation |
CYTER of Sri Balaji Vidyapeeth |
| Address |
Centre for Yoga Therapy, Edcuation and Research
I Block, 1st floor
Sri Balaji Vidyapeeth
Pillayarkuppam
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9442130267 |
| Fax |
|
| Email |
achudaa@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ananda Balayogi Bhavanani |
| Designation |
Director CYTER |
| Affiliation |
CYTER of Sri Balaji Vidyapeeth |
| Address |
CYTER
I Block, 1st floor
Sri Balaji Vidyapeeth
Pillayarkuppam
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9842311433 |
| Fax |
|
| Email |
yoga@mgmcri.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ananda Balayogi Bhavanani |
| Designation |
Director CYTER |
| Affiliation |
CYTER of Sri Balaji Vidyapeeth |
| Address |
CYTER
I Block, 1st floor
Sri Balaji Vidyapeeth
Pillayarkuppam
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9842311433 |
| Fax |
|
| Email |
yoga@mgmcri.ac.in |
|
|
Source of Monetary or Material Support
|
| Sri Balaji Vidyapeeth
Pillayarkuppam
Pondicherry 607402 |
|
|
Primary Sponsor
|
| Name |
Sri Balaji Vidyapeeth |
| Address |
Sri Balaji Vidyapeeth
Pondy Cuddalore Main Road
Pillayarkuppam
Pondicherry
607402 |
| Type of Sponsor |
Research institution |
|
|
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 |
| Artchoudane S |
Sri Balaji Vidyapeeth |
CYTER
I Block, 1st Floor
Sri Balaji Vidyapeeth
Pillayarkuppam
Pondicherry
607402
Pondicherry
PONDICHERRY |
9442130267
achudaa@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Chronic Obstructive Pulmonary Disorder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group |
COPD patients with regular medication only |
| Intervention |
Yoga group |
Yogic breathing practices include jattis, asana, pranayama and relaxation along with regular medication |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients with COPD on conventional medical management; Willing to participate in yoga therapy along with informed consent
|
|
| ExclusionCriteria |
| Details |
Inability/Contraindication to perform the yoga techniques in the protocol; Any active infections of lungs especially pulmonary tuberculosis
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| FEV1, FVC, FEV1/FVC; Symptoms, activity, impacts, total score of SGRQ |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Anthropometry |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
Final Enrollment numbers achieved (Total)= "68"
Final Enrollment numbers achieved (India)="68" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/05/2017 |
| Date of Study Completion (India) |
19/10/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="5"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
COPD patient in the age group of 30 to 65 years were recruited in pulmonary medicine OPD, MGMCRI & Hospital, Puducherry. After obtaining written informed consent, subjects were randomized into yoga and control group. Lung function variables FEV1, FVC and FEV1/FVC ratio as well as SGRQ (quality of life) variables including symptoms score, activity score, impact score and quality score were measured. Baseline comparison showed that both groups were comparable and then four weeks of yoga therapy was administered to yoga group. At the end of the study period, there was significant improvement in FEV1, FVC and SGRQ quality of life in the yoga group while there was a decline in lung function in control group.
|