| CTRI Number |
CTRI/2021/03/032105 [Registered on: 18/03/2021] Trial Registered Prospectively |
| Last Modified On: |
11/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Value of Immunomodulator drug(probiotics) in lung function of Bronchial Asthma subjects |
|
Scientific Title of Study
|
Evaluation of role of add on probiotics on impact of lung function and bronchial asthma control - 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 |
Boopathi S |
| Designation |
Post Graduate |
| Affiliation |
Chetinad Academy of Research and Education |
| Address |
Postgraduate Department of Respiratory Medicine Chettinad Health City Rajiv Gandhi Salai Kelambakkam Kancheepuram
Postgraduate Department of Respiratory Medicine Chettinad Health City Rajiv Gandhi Salai Kelambakkam Kancheepuram
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
9444238943 |
| Fax |
04447411011 |
| Email |
boopathis1993@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Meenakshi N |
| Designation |
Head of the Department |
| Affiliation |
Chetinad Academy of Research and Education |
| Address |
Department of Respiratory Medicine Chettinad Health City Rajiv Gandhi Salai Kelambakkam Kancheepuram
Department of Respiratory Medicine Chettinad Health City Rajiv Gandhi Salai Kelambakkam Kancheepuram
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
9840245981 |
| Fax |
04447411011 |
| Email |
paddy_2020@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Boopathi S |
| Designation |
Post Graduate |
| Affiliation |
Chetinad Academy of Research and Education |
| Address |
Postgraduate Department of Respiratory Medicine Chettinad Health City Rajiv Gandhi Salai Kelambakkam Kancheepuram
Postgraduate Department of Respiratory Medicine Chettinad Health City Rajiv Gandhi Salai Kelambakkam Kancheepuram
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
9444238943 |
| Fax |
04447411011 |
| Email |
boopathis1993@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Boopathi S
Postgraduate
Department of Respiratory Medicine
Chettinad Health City Rajiv Gandhi Salai
Kelambakkam Kancheepuram-603103 ph 9444238943
|
|
|
Primary Sponsor
|
| Name |
Boopathi S |
| Address |
Postgraduate Department of Respiratory Medicine Chettinad Academy of Research and Education Kelambakkam |
| Type of Sponsor |
Private 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 |
| Boopathi S |
Chettinad Hospital and Research centre |
Department of Respiratory Medicine opd 9 A block Rajiv Gandhi Salai Kelambakkam Kancheepuram District
Kancheepuram
TAMIL NADU |
9444238943
boopathis1993@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee,CARE |
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 |
Standard treatment (LABA - Salmeterol,Formoterol ect with ICS Budesonide etc)for bronchial asthma as per GINA guidelines |
Standard treatment (LABA - Salmeterol,Formoterol ect,ICS- Budesonide etc)for bronchial asthma daily for 2 months |
| Intervention |
Standard treatment for Bronchial asthma as per GINA guidelines (LABA - Salmeterol,Formoterol ect with ICS-Budesonide etc) combined with probiotic |
Add on therapy of probiotic (Lactobacillus fermentum) to standard treatment (LABA - Salmeterol,Formoterol ect with ICS-Budesonide etc) in bronchial asthma daily for 2 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All adult stable asthma with or without atopy and allergic rhinitis
Both genders |
|
| ExclusionCriteria |
| Details |
Acute Respiratory infection including Tuberculosis
Exacerbation
Subjects contraindicated and unable to perform spirometry
Underlying respiratory disorders |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the role of add on probiotics on impact of lung function by spirometry and bronchial asthma control |
Baseline,4 weeks,8 weeks and 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the impact of probiotics supplementation in risk of asthma exacerbation allergic rhinitis and its impact on asthma scoring |
3 months |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
20/03/2021 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a randomized parallel group trial to evaluate the role of add on probiotics (lactobacillus fermentum 4 billion cells once daily for 2 months) on impact of lung function and bronchial asthma control that will be conducted in Chettinad Hospital and Research Institute, Kelambakkam,Tamil Nadu, India.The primary outcome is to evaluate the role of add on probiotics on impact of lung function by spirometry and bronchial asthma control.The secondary outcome is to study the impact of probiotics supplementation in risk of asthma exacerbation,allergic rhinitis and its impact on asthma scoring for a period of 2 months. |