| CTRI Number |
CTRI/2023/10/058667 [Registered on: 16/10/2023] Trial Registered Prospectively |
| Last Modified On: |
13/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Standard routine treatment vs probiotics with standard routine treatment for allergic rhinitis |
|
Scientific Title of Study
|
Study on the effects of probiotics lactobacillus fermentum and paracasei in adult allergic rhinitis patients in a tertiary care center |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr veeraraman |
| Designation |
postgraduate |
| Affiliation |
Tagore medical college and hospital |
| Address |
Department of ENT
Tagore medical college and hospital, Rathinamangalam
chennai
Chennai
TAMIL NADU
600127
India |
| Phone |
9176818228 |
| Fax |
|
| Email |
veeraraman80@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anandkarthikeyan |
| Designation |
Professor |
| Affiliation |
Tagore medical college and hospital |
| Address |
Department of ENT
Tagore medical college and hospital, Rathinamangalam
chennai
Chennai
TAMIL NADU
600127
India |
| Phone |
7904864657 |
| Fax |
|
| Email |
anandkarthikeyan99@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anandkarthikeyan |
| Designation |
Professor |
| Affiliation |
Tagore medical college and hospital |
| Address |
Department of ENT
Tagore medical college and hospital, Rathinamangalam
chennai
Chennai
TAMIL NADU
600127
India |
| Phone |
7904864657 |
| Fax |
|
| Email |
anandkarthikeyan99@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tagore medical college and hospital,Rathinamangalam, chennai 600127 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 veeraraman |
Tagore medical college |
Department of ENT,
Tagore medical college and hospital
Chennai
TAMIL NADU |
9176818228
veeraraman80@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Tagore medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J309||Allergic rhinitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
probiotics(lactobacillus fementum and lactobacillus paracasei) |
study group will receive routine standard treatment for
allergic rhinitis with probiotics (lactobacillus fermentum and lactobacillus
paracasei) 1 capsule once daily(contains 4 billion cells)for2months for 45 patients |
| Comparator Agent |
routine standard medication for allergic rhinitis(intranasal steroids and anti histamines) |
routine standard medication for allergic rhinitis(intranasal steroids and anti histamines)are given for 2 months for 45 patients in control group |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All Adult Allergic rhinitis patients (age greater than 18 yrs ) reporting or being referred to the ENT
OPD in TAGORE MEDICAL COLLEGE AND HOSPITAL and who gives consent for
participation in the study |
|
| ExclusionCriteria |
| Details |
1 Pregnant women and children’s
2 Age less than 18 yrs.
3 Patients already on steroid medications for
known case of allergic rhinitis
4 Patients underwent endoscopic sinus surgeries
5 Immunocompromised individuals
6 Patients with chronic rhino sinusitis |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Benefits includes direct improvement and resolution of symptoms of allergic
rhinitis patient |
primary outcome assessed once in 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Benefits includes faster direct improvement and resolution of symptoms of allergic |
Total duration of study assessment is 2 months for each patients |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
23/10/2023 |
| 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="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
|
The aim of the study is to assess whether ingestion of Lactobacillus fermentum and Lactobacillus paracasei strain can improve the quality of life of the patients and resolution of symptoms of allergic rhinitis. |