| CTRI Number |
CTRI/2025/12/098954 [Registered on: 11/12/2025] Trial Registered Prospectively |
| Last Modified On: |
11/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Using Probiotics Along with Regular Treatment to Help Manage Mild to Moderate Asthma: A Clinical Study from South India |
|
Scientific Title of Study
|
A PROSPECTIVE STUDY TO COMPARE THE CLINICAL EFFICACY OF PROBIOTICS AS AN ADJUVANT TO STANDARD THERAPY IN A PATIENTS WITH MILD-MODERATE BRONCHIAL ASTHMA IN A TERTIARY CARE CENTRE IN SOUTH INDIA |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PREETHI S |
| Designation |
POSTGRADUATE |
| Affiliation |
ACS MEDICAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF PHARMACOLOGY,
ACS MEDICAL COLLEGE AND HOSPITAL,
Velappanchavadi
Chennai
TAMIL NADU
600077
India |
| Phone |
9790908660 |
| Fax |
|
| Email |
preethisidcosegar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr B Kalaiselvi |
| Designation |
Professor and Head of Department |
| Affiliation |
ACS MEDICAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF PHARMACOLOGY,
ACS MEDICAL COLLEGE AND HOSPITAL,
Velappanchavadi
Chennai
TAMIL NADU
600077
India |
| Phone |
9840311021 |
| Fax |
|
| Email |
drbkalaiselvi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
PREETHI S |
| Designation |
post graduate |
| Affiliation |
ACS MEDICAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF PHARMACOLOGY,
ACS MEDICAL COLLEGE AND HOSPITAL,
Velappanchavadi
Chennai
TAMIL NADU
600077
India |
| Phone |
09790908660 |
| Fax |
|
| Email |
preethisidcosegar@gmail.com |
|
|
Source of Monetary or Material Support
|
| ACS MEDICAL COLLEGE AND HOSPITAL |
|
|
Primary Sponsor
|
| Name |
PREETHI S |
| Address |
DEPARTMENT OF PHARMACOLOGY, ACS MEDICAL COLLEGE AND HOSPITAL,VELAPPANCHAVADI,THIRUVALLUR,TAMILNADU,INDIA |
| Type of Sponsor |
Other [self] |
|
|
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 |
| PREETHI S |
ACS medical college and hospital |
No.11, 1st floor, college block, velappanchavadi
Chennai
TAMIL NADU |
09790908660
preethisidcosegar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr.M.G.R.EDUCATIONAL AND RESEARCH INSTITUTE |
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 |
Standard therapy for Bronchial Asthma |
Enrolled participants will be divided into two groups a) Standard therapy for Bronchial asthma, b) Standard therapy with probiotics as adjuvant drugs twice a day, daily for 8weeks |
| Intervention |
Standard therapy for Bronchial Asthma with probiotics |
Enrolled participants will be divided into two groups a) Standard therapy for Bronchial asthma, b) Standard therapy with probiotics as adjuvant drugs twice a day, daily for 8weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Male or female patient with age group between 18-45 years.
Male or female patient, who met the diagnostic criteria for asthma, with temporarily stable asthmatic symptoms in non-acute attack stage that could be controlled by drug treatment.
Patients willing to give written and informed consent.
Conscious and co-operative patients
|
|
| ExclusionCriteria |
| Details |
Patients not willing to give consent
Male or female patient with any history of major disease, such as gastrointestinal diseases, long term requirement for glucocorticoids or other immunosuppressive agents, antibiotics intake 1 month before the trial.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of probiotics as an adjuvant therapy in the treatment of adults with moderate bronchial asthma. |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the reduction of drugs used in maintenance and as needed for asthma exacerbations.
|
8WEEKS |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 4 |
|
Date of First Enrollment (India)
|
27/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
27/12/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Patients with clinically confirmed bronchial asthma as per GINA criteria 2023 are enrolled in this study. Enrolled participants will be divided into two groups a) Standard therapy for Bronchial asthma, b) Standard therapy with probiotics as adjuvant drugs twice a day, daily for 8weeks Participants will be followed up after 2weeks, 4weeks and 8weeks after baseline visit. All participants will undergo complete blood count as routine investigation, included IgE level and PFT to be calculated and the outcome will be assessed at each visit. |