| CTRI Number |
CTRI/2023/01/048667 [Registered on: 02/01/2023] Trial Registered Prospectively |
| Last Modified On: |
30/12/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effects of yoga therapy, breathing exercises on the pulmonary function test parameters in mild to moderate bronchial asthma patients taking standard care treatment. |
|
Scientific Title of Study
|
Effects of combined yoga therapy with breathing exercises versus breathing exercises alone on the pulmonary function test parameters in mild to moderate bronchial asthma patients taking standard care treatment: a randomized control trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Dhanalakshmi Yerrabelli |
| Designation |
Additional Professor |
| Affiliation |
JIPMER, Puducherry. PONDICHERRY 605006 India |
| Address |
Department of Physiology, 1st floor, JIPMER Academic center. JIPMER, Puducherry.
PONDICHERRY
605006
India
Pondicherry
PONDICHERRY
605006
India |
| Phone |
09444781210 |
| Fax |
|
| Email |
saidhanalakshmi04@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dhanalakshmi Yerrabelli |
| Designation |
Additional Professor |
| Affiliation |
JIPMER, Puducherry. PONDICHERRY 605006 India |
| Address |
Department of Physiology, 1st floor, JIPMER Academic center. JIPMER, Puducherry.
PONDICHERRY
605006
India
Pondicherry
PONDICHERRY
605006
India |
| Phone |
09444781210 |
| Fax |
|
| Email |
saidhanalakshmi04@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Khuthejatal Kubra |
| Designation |
Junior Resident, Department of Physiology, JIPMER |
| Affiliation |
JIPMER, Puducherry. PONDICHERRY 605006 India |
| Address |
Department of Physiology, 1st floor, JIPMER Academic center. JIPMER, Puducherry.
PONDICHERRY
605006
India
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8317333594 |
| Fax |
|
| Email |
khuthejatalkubra1709@gmail.com |
|
|
Source of Monetary or Material Support
|
| Intramural fund, JIPMER, Puducherry, India |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
JIPMER campus, Dhanvantari nagar, Puducherry. |
| 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 |
| Khuthejatal Kubra |
Jawaharlal Institute of Postgraduate Medical Education and Research |
JIPMER Academic center, 1st floor. JIPMER, Dhanvanthri nagar Puducherry. PONDICHERRY
605006.
And: Department of Pulmonology, OPD Block, 1st floor, Physiotherapy room.
JIPMER, Puducherry.
PONDICHERRY
605006
India
Pondicherry
PONDICHERRY |
8317333594
khuthejatalkubra1709@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J454||Moderate persistent asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Participants only receiving only standard pharmacotherapy |
Participants Pulmonary Function Test parameters will be recorded in Physiology Department in the morning after which 5ml of fasting venous blood sample will be taken. The Participants will be called back after 12 weeks to the Physiology Department for recording Pulmonary Function Test parameters and collecting 5ml of venous blood sample. The participants will be given 2 questionnaires to be filled at the beginning pf the study and also after 3 months. |
| Intervention |
Physiotherapy |
participants falling under this group will be sent to the Pulmonology Department for learning Physiotherapy exercises from Physiotherapist every alternate day in the first week of the study following which they will continue doing the Physiotherapy exercises at home daily for a period of 11 weeks. After a period of 12 weeks from the start of the study, all the participants will also be called back to the Physiology Department for recording Pulmonary Function Test parameters and collecting 5ml of venous blood sample. The changes in Pulmonary Function Test parameters and venous blood before and after intervention will be compared. All the Participants will be requested to Fill 2 Questionnaires at the beginning of the study and after 3 months of the study. |
| Intervention |
Yoga and Pranayama along with Physiotherapy and standard drug therapy |
The participants falling under this group will be sent to the Pulmonology Department for learning Physiotherapy exercises from Physiotherapist and to the Yoga Centre in Physiology department to learn Yogasanas and Pranayamas from trained Yoga Instructors every alternate day in the first week of the study period after which they will be asked to practice the Physiotherapy exercises and Yogasanas at their home daily for a period of 11 weeks. After a period of 12 weeks from the start of the study, all the participants will also be called back to the Physiology Department for recording Pulmonary Function Test parameters and collecting 5ml of venous blood sample. The changes in Pulmonary Function Test parameters and venous blood before and after intervention will be compared. All the Participants will be requested to Fill 2 Questionnaires at the beginning of the study and after 3 months of the study. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Mild to Moderate severity of Bronchial Asthma patients of either gender of age group 20-60years on standard care treatment, visiting JIPMER Pulmonology OPD for treatment will be included in this study. |
|
| ExclusionCriteria |
| Details |
Severe asthma patients, patients already practicing yoga, breathing exercises or regular physical activity, patients with uncontrolled hypertension on drugs, patients with diabetes mellitus, pregnant females, participants with endocrine diseases requiring steroid treatment (rheumatoid arthritis, multiple sclerosis, Addison’s disease, systemic lupus erythematosus, inflammatory bowel disease), participants with severe obesity. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in Pulmonary Function Test parameters |
2 time points: At baseline and after 3 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. IL-4
2. IL-5
3. IL-13
4. IL-6
5. TNF- alpha
6. Asthma Quality of Life Questionnaire
7. Asthma APGAR Score |
2 time points: At baseline and after 3 months. |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
02/01/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
02/01/2023 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Patients with Mild to Moderate severity of Bronchial Asthma will be recruited from Pulmonology OPD of JIPMER, Puducherry after meeting the inclusion and exclusion criteria. After obtaining informed written consents, participant’s Pulmonary Function Test parameters will be recorded in Physiology Department in the morning after which 5ml of fasting venous blood sample will be taken. Following the blood sample collection Participants is allowed to have light breakfast. The Participants are Randomly allocated one of the groups among the three groups of this study using a random sequence generated by a computer. The participants falling under first group will be called back after 12 weeks to the Physiology Department for recording Pulmonary Function Test parameters and collecting 5ml of venous blood sample. The participants falling under second group will be sent to the Pulmonology Department for learning Physiotherapy exercises from Physiotherapist every alternate day in the first week of the study following which they will continue doing the Physiotherapy exercises at home daily for a period of 11 weeks. The participants falling under third group will be sent to the Pulmonology Department for learning Physiotherapy exercises from Physiotherapist and to the Yoga Centre in Physiology department to learn Yogasanas and Pranayamas from trained Yoga Instructors every alternate day in the first week of the study period after which they will be asked to practice the Physiotherapy exercises and Yogasanas at their home daily for a period of 11 weeks. After a period of 12 weeks from the start oif the study, all the participants from second and third group will also be called back to the Physiology Department for recording Pulmonary Function Test parameters and collecting 5ml of venous blood sample. The changes in Pulmonary Function Test parameters and venous blood before and after intervention will be compared. All the Participants will be requested to Fill 2 Questionnaires at the beginning of the study and after 3 months of the study. |