Health Condition 1: J393- Upper respiratory tract hypersensitivity reaction, site unspecified
Conditions
Interventions
Intervention1: Bepotastine besilate plus Montelukast sodium: Bepotastine Besilate 10mg/10mg plus Montelukast Sodium 5mg/10mg in tablet form and administered orally once a day for the duration of 14 d
Sponsors
Windlas Biotech Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Subjects who meet the following criteria are eligible for inclusion in the study: 1.Subject who agrees for giving informed consent and provide signed and dated written IEC/IRB approved Informed Consent Form (ICF) prior to initiation of any study procedures. 2.Male and Female subjects of group age >=18 to 3.Patient with symptoms of allergic rhinitis characterized by nasal pruritus, sneezing, rhinorrhea, and nasal congestion. 4.Patients with a Total Nasal Symptom Score (TNSS; the sum of all the 4 individual nasal symptom scores) of 6 or greater and/or a Total Ocular Symptom Score (TOSS; the sum of all the 3 individual ocular symptom scores) of 4 or greater and rhinitis symptoms. 5.Except Allergic Rhinitis disorders patient is judged to be in general good health based on medical history, physical examination and laboratory tests as assessed by the Investigator. 6.Written informed consent signed by patient and willing to comply with the study procedure. 7.Female patient of childbearing potential definitely using effective contraception during the study and willing to undergo pregnancy test.
Exclusion criteria
Exclusion criteria: 1.Subjects who are not able to or not willing to sign an IRB/IEC approved consent form. 2.Patients with known hypersensitivity to the study categories of medications. 3.Pregnant and lactating female patient. 4.Patient with known history of hypersensitivity to Bepotastine tablet or its components. 5.Patients receiving oral or topical H1 receptor antagonists within the last 48 hrs of enrolment. 6.Patients receiving antiallergic or antipruritic agents, antihistamines, corticosteroids, NSAIDs, tranquillizers and cold remedies within three days prior to the study. 7.Patients with upper respiratory tract infections within 30 days before the study 8.Rhinitis related to anatomic problems (polyps, septum deviation, etc.). 9.Patients with severe physical nasal obstruction or injury, nasal ulcers, recent nasal surgery, asthma, rhinitis medicamentosa, acute or chronic sinusitis, glaucoma, cataract, any psychiatric disorder, adrenal insufficiency, prostatism, diabetes mellitus and bacterial or viral infection within 2 weeks of participation in the study. 10.Patient with known and current use of alcohol or drug addiction. 11.Patient with previous participation in any clinical trial in past 1 month. 12.Any condition or concurrent severe disease that may preclude the patient from taking part in the clinical trial as per Investigatorâ??s discretion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy and safety of FDC of Bepotastine 10mg/10mg plus Montelukast Sod. 5mg/10mg in Indian patients diagnosed with Allergic Rhinitis.Timepoint: Treatment Phase from Day 1 (Week 1) to day 14 (Week 2) | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the number of subjects whose Allergic Rhinitis alleviated to normal in both groups (Study and Active Control).Timepoint: Treatment Phase from Day 1 (Week 1) to day 14 (Week 2) | — |
Countries
India
Contacts
Public ContactMukesh Kumar
RAHE
Outcome results
None listed