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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  
MINISTRY OF AYUSH VPCI 
 
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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).

 
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