Health Condition 1: null- Positive history of Allergic Rhinitis as judged by the Investigator
Conditions
Interventions
Intervention1: LP011-09: LP011-09 is herbal Intranasal formulation(Ayurvedic)
One spray each nostril twice daily for 14 days
Control Intervention1: Fluticasone Propionate: A Synthetic Corticosteroid used to treat Allergic Rhinitis
One spray each nostril twice daily for 14 days
Sponsors
Laila Pharmaceutical Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: • Males or Female subjects in the age group of 18 to 65 years • Subject has a medical history and past treatment of Allergic rhinitis (Written or verbal confirmation) which includes Seasonal or perennial symptoms (Nasal Congestion, Rhinnothea, Nasal itching and Sneezing, Ocular redness, Ocular itching, Ocular Tearing, Ocular burning, Ocular swelling) • Subject has 6 or more in the mean reflective total nasal symptoms (rTNSS) score in which nasal congestion accounts for 1 or more during last 2 days from screening visit. • Women with child-bearing potential & planning a pregnancy should be excluded or if otherwise, willing to adopt effective and approved birth control regimen for the entire trial duration (oral contraceptive, intrauterine device, barrier plus spermicide). • Subject has no clinically significant abnormal findings on the physical examination with the exception of head, ears, eyes, nose and throat findings consistent with allergic rhinitis, medical history which in the opinion of the Investigator would jeopardise the safety of the subjects or impact the validity of the study results • Subjects who are willing to complete all the study procedure and willing to adhere to the study protocol • The ability to understand and sign an informed consent form
Exclusion criteria
Exclusion criteria: • Female Subjects who are pregnant or lactating • Subject having complicated asthma which may require corticosteroids • Subject undergoing immunotherapy or has started the same in 1 month before the screening visit • Subject having complicated nasal disorders which may affect study efficacy (Acute or chronic rhinitis, hypertropic Rhinitis, Sinusitis, Septal Deviation, Nasal Polyp, Adenoid, and upper respiratory tract inflammation) • Subject having history of vasomotor rhinitis or eosonophilic rhinitis • Subject has serious (requiring Hospitalisation or surgery is indicated) hepatic disorder, renal disorder, heart disease, haematological disease, marrow disease and mental disease • Subject having acute , symptomatic respiratory tract infection within 2 weeks before screening • Subject has history of drug hypersensitivity • Subject has participated in another trial within 1 month prior to screening • Subject taking any anti-allergy medication that in the opinion of the investigator will affect the study assessment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the (AM+PM) reflective total nasal symptom score (rTNSS) at the end of treatment period (completion or discontinuation) compared to the baseline TNSS scoreTimepoint: Day0, Day 7 and Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change from baseline in reflective scores (AM+PM) of individual nasal symptoms (sneezing, rhinorrhea, nasal congestion, and nasal itching) Timepoint: Day0, Day 7 and Day 14;Mean change from baseline over the entire treatment period in individual daily reflective ocular symptom scores for Ocular redness, Ocular itching, Ocular Tearing, Ocular burning, Ocular swellingTimepoint: Day0, Day 7 and Day 14;Mean change over the entire treatment period in SF-36 Quality of Life Questionnaire scoresTimepoint: Day 7 and Day 14;Patientâ??s global evaluation of allergic rhinitisTimepoint: Day 7 and Day 14;Physicianâ??s global evaluation of allergic rhinitisTimepoint: Day 7 and Day 14 | — |
Countries
India
Contacts
Public ContactMr Sanjib Kumar Panda
Laila Pharmaceuticals Pvt Ltd
Outcome results
None listed