Title of Study: A randomized, parallel, double-blind, multi-center, comparative study to evaluate the efficacy and safety of Cosalin monotherapy versus Cosalin and Xarlin combination therapy in patients with allergic rhinitis Objective of study: To exploratively evaluate superiority of combination therapy - twice-daily Cosalin Tab (Petasites hybridus CO2 extract) with once-daily Xarlin Tab (Levocetirizine HCl) - compared to monotherapy of Cosalin with allergic rhinitis subjects.
Number of Subjects: Total 100 subjects / Each group 50 subjects (combination therapy group, monotherapy group / include 20% of subjects drop out rate) Test Products: Cosarlin (Petasites hybridus CO2 extract) 30 mg tablet Xarlin (Levocetirizine HCl) 5 mg tablet Study Design: Development Phase: Phase IV Randomized, double blind, active-controlled, multi-center study The subject, who is to satisfy inclusion criteria and not to satisfy any of exclusion criteria will be allocated 1:1 to combination therapy group or mono therapy group, randomized. Written informed consent will be obtained from the subjects prior to study entry. Dose, Mode of administration: Monotherapy group - Cosalin 30mg tablet two times daily. Combination therapy group - Cosalin 30mg tablet two times daily and Xarlin 5mg tablet once daily. Duration of Tx: 2 Weeks Safety Endpoint: Physical Exam, Adverse Events, Vital Signs at Visit 2 and 3.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
Combination therapy compared to mono therapy
Combination therapy compared to mono therapy
Compare efficacy improvement of combination therapy group and mono therapy group by percent change of 4 TSS from baseline to end of treatment by investigator.
Time frame: 2 weeks
Compare percent change of evening reflective 4 TSS from baseline to end of treatment by using patient diary.
Time frame: 2 weeks
Compare percent change of instantaneous 4 TSS from baseline to end of treatment by using patient diary.
Time frame: 2 weeks
Compare percent change of evening reflective nasal congestion score from baseline to end of treatment by using patient diary.
Time frame: 2 weeks
Compare percent change of instantaneous nasal congestion score from baseline to end of treatment by using patient diary.
Time frame: 2 weeks
Compare percent change of evening reflective 5 TSS (5 TSS - runny nose, itchy nose, sneezing, ocular symptom, nasal congestion)by using patient diary.
Time frame: 2 weeks
Compare percent change of instantaneous 5 TSS by using patient diary.
Time frame: 2 weeks
Compare percent change of evening reflective 4 TSS from baseline to each day by using patient diary.
Time frame: 2 weeks
Compare percent change of instantaneous 4 TSS from baseline to each day by using patient diary.
Time frame: 2 weeks
Compare improvement of QoL from baseline to end of treatment, by using RQLQ (Rhinoconjunctivitis Quality of Life Questionnaire).
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Time frame: 2 weeks
Compare responder rate (> 50% evening reflective 4TSS improvement) by using patient's diary.
Time frame: 2 weeks