CTRI Number |
CTRI/2018/03/012731 [Registered on: 22/03/2018] Trial Registered Retrospectively |
Last Modified On: |
14/03/2018 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Yoga & Naturopathy |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
Effect of Yoga on respiratory disease |
Scientific Title of Study
|
A clinical study to evaluate the effects of yogic intervention on pulmonary functions, inflammatory markers, oxidative stress and health status in patients of Chronic Obstructive Pulmonary Disease (COPD) |
Trial Acronym |
Yoga |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
DR KAVITA GULATI |
Designation |
Professor |
Affiliation |
Vallabhbhai Patel Chest Institute Delhi |
Address |
Department of Pharmacology Vallabhbhai Patel Chest Institute University of Delhi Delhi Department of Pharmacology
Vallabhbhai Patel Chest Institute, Univ. of Delh New Delhi DELHI 110007 India |
Phone |
9818033085 |
Fax |
|
Email |
kavgul2002@yahoo.com |
|
Details of Contact Person Scientific Query
|
Name |
Suresh Kumar Thokchom |
Designation |
Doctoral Student |
Affiliation |
Vallabhbhai Patel Chest Institute |
Address |
Department of Pharmacology Vallabhbhai Patel Chest Institute University of Delhi Delhi Department of Pharmacology
Vallabhbhai Patel Chest Institute, Univ. of Delh New Delhi DELHI 110007 India |
Phone |
|
Fax |
|
Email |
sur.man220@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Suresh Kumar Thokchom |
Designation |
Doctoral Student |
Affiliation |
Vallabhbhai Patel Chest Institute |
Address |
Department of Pharmacology Vallabhbhai Patel Chest Institute University of Delhi Delhi Department of Pharmacology
Vallabhbhai Patel Chest Institute, Univ. of Delh North East DELHI 110007 India |
Phone |
|
Fax |
|
Email |
sur.man220@gmail.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
Vallabhbhai Patel Chest Institute |
Address |
Vallabhbhai Patel Chest Institute, University of Delhi-07 |
Type of Sponsor |
Government medical college |
|
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 |
Prof Kavita Gulati |
Out Patient Department (OPD) of Pulmonary Medicine, Viswanathan Chest Hospital |
Department of Pharmacology, 1st Floor, M.S Building, V P Chest Institute,
University of Delhi North DELHI |
9818033085
kavgul2002@yahoo.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
VPCI Human Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Mild and Moderate COPD, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Fixed dose inhaler of corticosteroid and b2 agonist
Yoga |
2 puffs per day
Yoga for 50 minutes |
Comparator Agent |
Fixed dose inhaler of corticosteroid and b2 agonist |
2 puffs per day |
|
Inclusion Criteria
|
Age From |
40.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
Patients of 40-65 age groups, irrespective of gender
Patients with clinical diagnosis of COPD
Patient who has given written informed consent to participate in the study
Patient relatively stable, ambulatory and cooperative
Smokers (anyone who had smoked during the last one year will be considered a smoker) and non- smokers
|
|
ExclusionCriteria |
Details |
Patient below 40 years and above 65 years
Unwilling patients
Patients had any respiratory tract infection during the past 4 week
Patients with any other systemic disorder viz. diabetes mellitus, rheumatic heart disease, renal disease, hepatic dysfunction, any CNS disorder etc.
Pregnant / lactating females
Patients hypersensitive to any of the conventional COPD drugs
Patients who cannot attend Yoga course for any reason
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Case Record Numbers |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
Improved Pulmonary functions |
3 months |
|
Secondary Outcome
|
Outcome |
TimePoints |
Improved Quality of Life
Markers of oxidative stress and inflammation |
3 months |
|
Target Sample Size
|
Total Sample Size="70" Sample Size from India="70"
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)
|
10/01/2017 |
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="1" Months="10" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
|
No |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
The
present study is a randomized, open label, parallel design, controlled clinical
study to evaluate the effects of yogic intervention on pulmonary functions,
clinical symptoms, oxidative stress markers, inflammation & immunity
markers and health status parameters, in patients of COPD. COPD is a chronic
inflammatory disorder with associated immunological changes, hence markers of
inflammation, immunity and oxidative stress will be assessed in both controls
as well as yoga exposed groups (both groups will be given Fixed dose inhaler and
SOS L-Salbutamol treatment for COPD). Research methodology is as per ICH-GCP
guidelines and protocol has been approved by the Institutional Ethical Committee.
In the area of monitoring COPD, FeNO correlates with symptom frequency and
bronchodilator use, therefore, in the present study FeNO will be used to
predict the response of COPD patients to yogic intervention. The BODE index, is
a multidimensional scoring system and capacity index used to test patients who
have been diagnosed with COPD and to predict long-term outcomes for them. The
index uses four factors (Body-mass, Obstruction, Dyspnea, and Exercise) to
predict risk of death from the disease. Isoprostanes are prostaglandin analogs
produced by free radical-catalyzed peroxidation of arachidonic acid.
8-isoprostane is useful in the measurement of oxidative stress in lungs,
systemic oxidative stress. In addition to
these, markers of inflammation and immunity viz. osteoprotogerin, CC-16, TNF-α,
will be measured in patients of COPD. This will be correlated with the blood
cells counts i.e. neutrophil-lymphocyte ratio, which play an important role in
the early and late phase of COPD. Finally, the effects of yogic intervention on
quality of life parameters will be assessed by using St. George’s Respiratory
Questionnaire for COPD patients (SGRQ-C). |