| CTRI Number |
CTRI/2024/05/067610 [Registered on: 20/05/2024] Trial Registered Prospectively |
| Last Modified On: |
16/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of yoga practices on bronchial asthma |
|
Scientific Title of Study
|
Evaluation of efficacy of Yogic Practice on Bronchial Asthma |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Monika Devi |
| Designation |
Ph.D Scholar |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Vikriti Vigyan, Faculty of Ayurveda, Institute of medical sciences, Banaras Hindu University, Varanasi, Uttar Pardesh, India
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7505433435 |
| Fax |
|
| Email |
monikapchaudhary7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Parameswarappa S Byadgi |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences |
| Address |
Department of Vikriti Vigyan, Faculty of Ayurveda, Institute of Medical Sciences
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9450711759 |
| Fax |
|
| Email |
psbyadgi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Parameswarappa S Byadgi |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences |
| Address |
Department of Vikriti Vigyan, Faculty of Ayurveda, Institute of Medical Sciences
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9450711759 |
| Fax |
|
| Email |
psbyadgi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Vikriti Vigyan, Faculty of Ayurveda, IMS, BHU, Varanasi, India, 221005 |
|
|
Primary Sponsor
|
| Name |
Head Department of Vikriti Vigyan |
| Address |
Faculty of Ayurveda Institute of Medical Sciences BHU Varanasi |
| 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 |
| Dr PS Byadgi |
Institute of Medical sciences Sir Sunderlal Hospital |
Room No. 23 Indian Medicine Wing Sir Sunderlal Hospital Institute of Medical Sciences Banaras Hindu University Varanasi UTTAR PRADESH
Varanasi
UTTAR PRADESH |
9450711759
psbyadgi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Ethics Committee, Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J459||Other and unspecified asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Inhale corticosteroids (ICS) + Long – Acting Beta Agonists (LABA)
Antihistamine + Leukotriene receptor antagonist (LTRA) |
twice daily for 90 days |
| Intervention |
Inhale corticosteroids (ICS) + Long – Acting Beta Agonists (LABA)
Antihistamine + Leukotriene receptor antagonist (LTRA) + yoga practices • Deep breathing
Neck roll, Shoulder roll, Gomukhasana, Makarasana, Ardh Chandra asana, Pashimottanasana, Diaphragmatic Breathing, Kapalbhati pranayama, Jalandhara bandha, savasana, Closing Thoughts |
Inhale corticosteroids (ICS) + Long – Acting Beta Agonists (LABA)
Antihistamine + Leukotriene receptor antagonist (LTRA) twicw daily for 90 days + yoga practices • Deep breathing
Neck roll, Shoulder roll, Gomukhasana, Makarasana, Ardh Chandra asana, Pashimottanasana, Diaphragmatic Breathing, Kapalbhati pranayama, Jalandhara bandha, savasana, Closing Thoughts once daily for 90 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are willing to perform yogic practices as per the need of the study
Diagnosed patients of mild to moderate bronchial asthma by the treating physician
Mild to moderate bronchial asthma less then 50 percent FEV1 |
|
| ExclusionCriteria |
| Details |
Patients who are not willing to perform yogic interventions.
Patient of less than 18 and more than 60 years of age.
Patients who are not able to perform yogic interventions.
severe bronchial asthma and Chronic obstructive pulmonary disease (COPD), interstitial lung disease (ILD).
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the effect of Yogic Practices on Bronchial Asthma
|
90 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To analyse the impact of Yogic Practices on spirometry findings in
Bronchial Asthma.
To assess the impact of Yogic Practices on Quality of Life on
Bronchial Asthma.
To assess the impact of Yogic Practices in the Management of
Bronchial Asthma by Asthma Quality of Life Questionnaire
(AQLQ).
To assess the impact of Yogic Practices in the Management of
Bronchial Asthma by Asthma Control Questionnaire (ACQ).
|
90 days |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
27/05/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A total of 120 patients suffering from mild to moderate bronchial asthma will be selected and will be randomly divided into two groups. First group will receive modern medicine and second group will receive modern medicine along with yogic practices for 90 days. The data will be analyzed to evaluate the efficacy of yogic practices in reliving the symptoms of bronchial asthma in comparison to modern medicine. |