| CTRI Number |
CTRI/2018/01/011341 [Registered on: 15/01/2018] Trial Registered Retrospectively |
| Last Modified On: |
16/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Yoga] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of short-term yoga-based intervention on
in bronchial asthma patients:A Randomised controlled trial |
|
Scientific Title of Study
|
Effect of short-term yoga-based lifestyle intervention on stress,airway resistance and inflammation in bronchial asthma patients:A Randomised controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Eva |
| Designation |
MD |
| Affiliation |
All India Institute of medical sciences |
| Address |
Integral Health Clinic,Department of Physiology,Teaching Block,All India Institute of medical sciences,New Delhi
South
DELHI
110049
India |
| Phone |
8826724354 |
| Fax |
|
| Email |
evasharan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Raj Kumar Yadav |
| Designation |
Professor |
| Affiliation |
All India Institute of medical sciences |
| Address |
Integral Health Clinic,Department of Physiology,Teaching Block,All India Institute of medical sciences,New Delhi
South
DELHI
110049
India |
| Phone |
9811319057 |
| Fax |
|
| Email |
raj3kr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Eva |
| Designation |
MD |
| Affiliation |
All India Institute of medical sciences |
| Address |
Integral Health clinic,Department of Physiology,Teaching Block,All India Institute of medical sciences,New Delhi
South
DELHI
110049
India |
| Phone |
8826724354 |
| Fax |
|
| Email |
evasharan@gmail.com |
|
|
Source of Monetary or Material Support
|
| PG research,All India Institute of medical sciences,New Delhi |
|
|
Primary Sponsor
|
| Name |
All India Institute of medical sciences |
| Address |
All India Institute of medical sciences,New Delhi |
| 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 |
| Eva |
All India Institute of medical sciences |
Integral Health clinic,Department of physiology,Teaching block,All India Institute of medical sciences
South
DELHI |
8826724354
evasharan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Mild to moderate bronchial asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group |
Spirometry and impulse oscillometry done at day 0 and day 30 |
| Intervention |
Yoga |
Asanas,pranayam,meditation for 14 days in Integral Health clinic and follow up at home for 14 days.impulse oscillometry,serum cortisol,serum endorphin,IL-5,ECP,spirometry done at day 0,day 14 and day 30 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Age:18-50 years
2.Mild to moderate group of asthma
3.Duration of asthma more than 2 years
4.Diagnosed bronchial asthma patients referred from 5.Department of Medicine/Pulmonary medicine/diagnosed asthma patients attending Integral Health clinic for Yoga intervention /from advertisements. |
|
| ExclusionCriteria |
| Details |
1.Individuals with inability to perform Yogic asanas
2.Patients with severe asthma
3.Asthma patients having acute respiratory infections
4.Recent hospitalisations in last one month
5.Patients with associated co-morbidities like severe hypertension,ischemic heart disease etc. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Stress
airway resistance
inflammation |
Day 0,Day 14,Day 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
stress
airway resistance
inflammation |
Day 0,Day 14,Day 30 |
|
|
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)
|
17/04/2017 |
| 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="2"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Bronchial Asthma is a heterogenous disease,usually characteized by chronic airway inflammation.The effect of stress in relation to the airway resistance and inflammation in bronchial asthma patients is yet to be studied in detail. |