Health Condition 1: J309- Allergic rhinitis, unspecified
Conditions
Interventions
Intervention1: Ebastine (10 mg) and Phenylephrine (10 mg): Subjects will be administered with FDC of Ebastine (10 mg) and Phenylephrine (10 mg) once daily for 5 days.
Control Intervention1: NIL: NIL
Sponsors
Sterling Lab
Eligibility
Inclusion criteria
Inclusion criteria: 1. Diagnosis of mild and moderate-severe intermittent allergic rhinitis ( 2. Able to provide informed consent to participate in the study 3. Ability to understand study procedures and to comply with them for the entire length of the study including able to record symptom scores in a diary (literate patients). 4. TSS baseline score of at least 5 both on screening and randomization day (based on investigator assessment) 5. Treatment naive for current episode of allergic rhinitis [if patient has already consumed any medication for the current episode, then a wash-out of about 6-7 days to be given before administering study medication
Exclusion criteria
Exclusion criteria: 1. Asthma patients 2. Subjects with a current history of frequent, clinically significant sinusitis or chronic purulent postnasal drip. 3. Subjects who, in the opinion of the investigator, are dependent on nasal, oral or ocular decongestants, nasal topical antihistamines or nasal steroids. 4. Any illness requiring steroid by any route. 5. Urticaria, Vasomotor rhinitis, Rhinitis medicamentosa. 6. Subjects who have, in the opinion of the investigator or designee, clinically significant nasal structural abnormalities, including large nasal polyps or marked septum deviation, that significantly interferes with nasal air flow. 7. Pregnancy or lactation. 8. Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements. 9. Use of any other investigational drug in the last 90 days. 10. Subjects known to have an idiosyncratic reaction to any of the ingredients in IMP
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the safety of FDC of Ebastine and Phenylepherine using adverse event profile as volunteered by the patients and evaluated by the investigatorTimepoint: Baseline and Day 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability: The adverse effects of the study drug will be assessed by monitoring adverse events, vital signs, physical examination and clinically significant changes in laboratory parametersTimepoint: Baseline and Day 6;To compare the change in Total Symptom Score [(TSS is the sum Total nasal symptom score (TNSS) and Total Ocular symptom score (TOSS)] at the end of 5 days from baseline to end lineTimepoint: Baseline and Day 6 | — |
Countries
India
Contacts
Public ContactNitish S
Dr. B.R. Ambedkar Medical College and Hospital
Outcome results
None listed