The efficacy and safety of So-Cheong-Ryong-Tang for perennial allergic rhinitis

Not Applicable

Recruiting

Conditions: Diseases of th respiratory system

Registration Number: KCT0002225

Lead Sponsor: Kyung Hee University

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 154

Inclusion Criteria

(1) age 19-60 years;
(2) presence of two or more nasal symptoms (rhinorrhea, nasal congestion, nasal itching and sneezing) with severity score = 2 (0 = no symptom, 1 = mild symptom, 2 = moderate symptom, and 3=severe symptom);
(3) presence of nasal symptoms more than 2 consecutive years; and
(4) positive reaction to the one or more perennial allergen in skin prick test.

Exclusion Criteria

(1) treatment with nasal/oral corticosteroids within the past month; nasal cromolyn or tricyclic antidepressants within the past two weeks; or nasal/oral decongestants, nasal/oral antihistamines, or antileukotrienes within the past week;
(2) presence of rhinosinusitis (paranasal sinus X-ray demonstrating mucosal thickening, or partial or complete opacification of the paranasal sinuses);
(3) presence of hypertension (systolic = 180 mmHg or diastolic = 100 mmHg);
(4) presence of abnormal liver function (aspartate transaminase (AST) or alanine transaminase (ALT) = 100 IU/L) or abnormal renal function (blood urea nitrogen (BUN) = 30 mg/dL or creatinine = 1.8 mg/dL (male), 1.5 mg/dL (female));
(5) presence of neoplasm, severe systemic inflammation, other systemic disease that affects rhinitis;
(6) history of drug allergy;
(7) history of anaphylaxis for allergic tests;
(8) pregnancy or lactation; or
(9) participation of other clinical study within the past 3 months.

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total nasal symptom score (TNSS)

Secondary Outcome Measures

Name	Time	Method
Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) ;Total serum IgE level, eosinophil count, and cytokine level;The levels of aspartate aminotransferase (AST) / alanine aminotransferase (ALT);Result of blood urea nitrogen test, creatine blood test