| CTRI Number |
CTRI/2018/06/014380 [Registered on: 01/06/2018] Trial Registered Prospectively |
| Last Modified On: |
30/05/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Impact of Yoga and Pranayama in patients with Respiratory problems: A Pilot Study |
|
Scientific Title of Study
|
Impact of Yoga and Pranayama on Respiratory Functions in Patients with Scoliosis: A Pilot Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bhavuk Garg |
| Designation |
Associate Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Dept of orthopaedics 139 D First floor Teaching block AIIMS
Room No 5036 A fifth floor teaching block Dept of orthopaedics AIIMS new Delhi
New Delhi
DELHI
10029
India |
| Phone |
9868397116 |
| Fax |
|
| Email |
drbhavukgarg@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhavuk Garg |
| Designation |
Associate Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Dept of orthopaedics 139 D First floor Teaching block AIIMS
Room No 5036 A fifth floor teaching block Dept of orthopaedics AIIMS new Delhi
DELHI
10029
India |
| Phone |
9868397116 |
| Fax |
|
| Email |
drbhavukgarg@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhavuk Garg |
| Designation |
Associate Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Dept of orthopaedics 139 D First floor Teaching block AIIMS
Room No 5036 A fifth floor teaching block Dept of orthopaedics AIIMS new Delhi
DELHI
10029
India |
| Phone |
9868397116 |
| Fax |
|
| Email |
drbhavukgarg@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of AYUSH, Ministry of health and family welfare, GOI |
|
|
Primary Sponsor
|
| Name |
AYUSH Ministry of Health and family Welfare GOI |
| Address |
Department of AYUSH, Ministry of Health and family Welfare, GOI |
| Type of Sponsor |
Government funding agency |
|
|
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 Bhavuk Garg |
AIIMS New Delhi |
Department of Orthopaedics, Teaching Block, AIIMS, New Delhi
New Delhi
DELHI |
9868397116
drbhavukgarg@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Scoliosis patients attending scoliosis OPD of orthopaedic department, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
standard Pulmonary function improvement exercises |
patients with scoliosis will go to Yoga or general pulmonary rehabilitation arm |
| Intervention |
Yoga and Pranayama |
Randomised patients with scoliosis will go to Yoga therapy |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
young patients with Scoliosis |
|
| ExclusionCriteria |
| Details |
patients other than scoliosis and patients who do not wish to participate |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The outcome of this study may open new frontiers in treatment of spinal deformities by maximizing their respiratory reserve and will endorse the role of ‘Yoga’ in the management of such respiratory disorders which are mainly structural in nature. |
0, 6th and 12th month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| This study might encourage other centers to incorporate Yoga as additional treatment plan for the patients with respiratory distress |
6th and 12th month of the study |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
02/07/2018 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
There are many reports documenting benefits of Yoga and pranayama on respiratory function |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
With the aim of promoting normal lung development and pulmonary function,
the present study is an attempt to investigate that weather
‘Yogic exercises’ and ‘Pranayama’ can be useful for the improvement of respiratory
functions in patients with scoliosis. The
ultimate purpose of Yoga and Pranayama is for spiritual enlightenment or for
self realization with overall health benefits as well. Here our attempt is to analyze
the health benefits from Pranayama with a special emphasis on respiratory
functional outcome in patients with scoliosis.
Since,
there are no studies conducted on the effect of ‘Pranayama’ on impaired
respiratory functions in patients with scoliosis, hence we propose this study. |