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CTRI Number  CTRI/2020/02/023534 [Registered on: 24/02/2020] Trial Registered Prospectively
Last Modified On: 23/03/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Evaluating the effect of Yoga in Management of Asthma. 
Scientific Title of Study   Evaluating the effect of Yoga in Management of Asthma: A Single Blind Randomized 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  Anshu  
Designation  Ph.D. Scholar 
Affiliation  All India institute of medical science, rishikesh 
Address  Department of pulmonary medicine, medical college 6th flor, All India institute of medical science, virbhadra road rishikesh, uttrakhand
Department of pulmonary medicine, medical college 6th flor, All India institute of medical science, virbhadra road rishikesh, uttrakhand
Dehradun
UTTARANCHAL
249203
India 
Phone  9997285995  
Fax    
Email  anshuarya7732@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Girish Sindhwani 
Designation  professor and head of pulmonary medicine 
Affiliation  All India institute of medical science, rishikesh 
Address  Department of pulmonary medicine, medical college 6th flor, All India institute of medical science, virbhadra road rishikesh, uttrakhand
Department of pulmonary medicine, medical college 6th flor, All India institute of medical science, virbhadra road rishikesh, uttrakhand
Dehradun
UTTARANCHAL
249203
India 
Phone  7895050321  
Fax    
Email  girish.sindhwani75@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Girish Sindhwani 
Designation  professor and head of pulmonary medicine 
Affiliation  All India institute of medical science, rishikesh 
Address  Department of pulmonary medicine, medical college 6th flor, All India institute of medical science, virbhadra road rishikesh, uttrakhand
Department of pulmonary medicine, medical college 6th flor, All India institute of medical science, virbhadra road rishikesh, uttrakhand
Dehradun
UTTARANCHAL
249203
India 
Phone  7895050321  
Fax    
Email  girish.sindhwani75@gmail.com  
 
Source of Monetary or Material Support  
Uttarakhand State Council for Science & Technology(UCOST) Vigyna Dham, Jhajra, Premnagar, Dehradun Uttrakhand 248007 
 
Primary Sponsor  
Name  Uttarakhand state council for science technologyUCOST 
Address  Vigyna Dham, Jhajra, Premnagar, Dehradun, Uttarakhand 248007 
Type of Sponsor  Government funding agency 
 
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 
Anshu  All india institute of medical science, Rishikesh  Department of pulmonary medicine, medical college 6th flor, AIIMS veerbhadra road near barrage Rishikesh uttarakhand
Dehradun
UTTARANCHAL 		 9997285995

anshuarya7732@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical committee AIIMS Rishikesh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J453||Mild persistent asthma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  joints loosening exercise with conventional therapy  1 Neck Movements rotation 2 Shoulder Socket rotation 3 Wrist bending 4 Wrist rotation 5 Elbow bending 6 Toe bending 7 Knee crank 
Intervention  yoga therapy with conventional therapy  Gomukhasana (cow face pose)-2 rounds, Bhujangasana (cobra pose)-2 rounds, Ardhamatsyendrasana (half spinal twist)-2 rounds, Dhanurasana (bow pose)-2 rounds, Tadasana (mountain standing pose)-2 rounds, shavasana (relaxing asana)-5 minutes, Bhastrika pranayama-20 strokes, Nadishodhan pranayama-10 cycle, om chanting-7-10 times, meditation-5 minutes, 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Stable patients not in exacerbation in last one month
2. Mild to moderate -as per GINA- Global initiative for Asthma guideline
 
 
ExclusionCriteria 
Details  1.Patients with other ailments which can hamper with yoga protocol such as Musculoskeletal disorder, cervical, back pain
2.Arthritis, hypertension, other major disease
3.Not willing to participate in the study
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Pulmonary function test including FeV1, FVC
2.Health related Quality of life (SGRQ score)
3.Spirometer pre and post bronchodilator
4.Exacerbation (frequency of attacks)
5.Asthma control test  		 After baseline data collection we will take 1st follow up in 4th week, 2nd follow up in 8th week and 3rd follow up in 12th week 
 
Secondary Outcome  
Outcome  TimePoints 
1.Airway reactance and resistance
2.HRV biofeedback will be done to assess the effect of yoga
 		 After baseline data collection we will take 1st follow up in 4th week, 2nd follow up in 8th week and 3rd follow up in 12th week 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "200"
Final Enrollment numbers achieved (India)="200" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/03/2020 
Date of Study Completion (India) 18/09/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 12 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Background:

Asthma is one of the common non-communicable diseases (NCDs). It affects around 339 million people in all regions of the world. It is a cause of substantial burden of disease, including both premature death and reduced quality of life, in people of all ages in all parts of the world.Asthma’s principal symptoms result primarily from bronchoconstriction and a resulting reduction in airflow. These symptoms include shortness of breath, cough, wheezing, and chest pain or tightness. The associated reduction in airflow is usually reversible spontaneously or with treatment.

Material and methods:

A Randomized controlled trial will be conducted on 200 asthmatic patients. The subjects will be recruited from out-patient department of Pulmonary Medicine, All India Institute of Medical Sciences, Rishikesh. Patients will be allocated to two groups: group A (Intervention group) and group B (control group). Patients in group A will be treated with pre-designed yogic practices along with conventional medical therapy for 30 minutes every day for a period of 3 months. Group B will be treated with conventional medication and joints loosening exercises for 30 minutes every day for a period of 3 months. Subjective assessment, spirometry indices including Forced Expiratory Volume in first second (FEV1%), Peak Expiratory Flow Rate (PEFR) and quality of life will be done every month in both the groups uptill 6 months from baseline.

Statistical analysis:

Statistical methods used to compare group outcomes will be T test, repeated measures ANOVA and Chi Square using intention to treat analysis method. A p value of <0.05 would be considered significant.

 
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