A clinical trial to evaluate efficacy and safety of probiotics as immunomodulators in acute allergic rhinitis.
- Conditions
- Health Condition 1: J308- Other allergic rhinitis
- Registration Number
- CTRI/2020/09/027657
- Lead Sponsor
- Advanced Enzyme Technologies Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 80
Subjects who have given written informed consent to participate in the study.
2. Subjects of either sex aged between 18 to 65 years (both inclusive) with acute allergic rhinitis.
3. At the time of the enrolment subject should have an investigator assessed:
A. Total Four Nasal Symptom Score of 4 -10 (both inclusive) with minimum nasal stiffness score of 2.
B. Total Two Ocular Symptom Score of 1 â?? 5 (both inclusive)
C. Cough with a score of 0-1 in a 4-point scale.
1.Subjects with history of hypersensitivity to antihistamines or any of the excipients of study formulations.
2.Subjects with nasal structural abnormalities (including deviated nasal septum, nasal polyps etc.)
3.Subjects using nasal sprays or with nasal, ocular, sinus surgery in past 6 months.
4.Subjects with history of disorders of nasolacrimal drainage.
5.Subjects with rhinitis medicamentosa (defined as a condition characterized by nasal congestion without rhinorrhoea or sneezing that is triggered by the use of topical nasal decongestants for more than 4-6 days).
6.Subjects receiving immunotherapy for at least 6 months prior to enrollment in this study.
7.Subjects who have received intranasal/systemic corticosteroids in the past 4 weeks or cromolyn sodium in the last 2 weeks or are having any antibiotic therapy.
8.Subjects who would be requiring concomitant chronic or intermittent use of oral, intravenous, intramuscular, topical or inhaled corticosteroids.
9.Subjects with significant disease(s) or disorder(s) other than seasonal allergic rhinitis that in the opinion of the investigator may
(i) put the subject at risk because of participation in the study (ii) interfere with the study evaluations or
(iii) cause concern regarding subjectâ??s ability to participate in the study.
10.Subjects with history of substance abuse
11.Pregnant or breast-feeding women or women of child-bearing potential not using medically acceptable methods of contraception or women with positive serum pregnancy test at screening.
12.Subjects who are unable or unwilling to comply with the study procedures.
13.Subjects who have participated in another investigational study within the last 3 months prior to entry in this study.
14.Subjects who are likely to travel outside the study area for a substantial portion of the study period.
15.Subjects with self-reported chronic diseases like diabetes, kidney diseases, cardiovascular disease
16.Subjects on treatment with any kind of CNS disease (self-reported).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Mean change in T4NSS, T2OSS and cough scores at each visit as well as from baseline to EOT. <br/ ><br>2.Percent change in T4NSS, T2OSS and cough scores at each visit as well as from baseline to EOT. <br/ ><br>3.Mean difference in TH1, TH2 TH17 and Treg cells from baseline to EOT <br/ ><br>4.Changes in Markers of FOXP3, IL4, IL10, IL17, IL22, IFN-γ, TNF-β, and TNF-α from baseline to EOT <br/ ><br>5.Responder rate for T4NSS, T2OSS and cough score <br/ ><br>6.Time to response for T4NSS, T2OSS and cough score <br/ ><br>Timepoint: 4 weeks
- Secondary Outcome Measures
Name Time Method 1.Change in vital signs (body temperature, systolic blood pressure, diastolic blood pressure, pulse rate and respiration rate) at each visit. <br/ ><br>2.Change in following parameters at visit 1, 3 and 5 <br/ ><br>3. Rate of incidence of AE and SAEâ??s during the Study duration.Timepoint: 4 weeks