Efficacy and Safety of So-Cheong-Ryong-Tang on Perennial Allergic Rhinitis

Study Overview
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Brief Summary
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The aim of this study is to investigate the short and long term efficacy and the safety of SCRT treatment for PAR

Official Title
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Efficacy and Safety of So-Cheong-Ryong-Tang on Perennial Allergic Rhinitis: Study Protocol for a Double-blind, Randomized, Parallel-group, Multi-center Trial

Conditions
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Perennial Allergic Rhinitis

Intervention / Treatment
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* Drug: SCRT
* Drug: Placebos


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18-60 years 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) presence of nasal symptoms more than 2 consecutive years; and positive reaction to the one or more perennial allergen in skin prick test. Exclusion Criteria: 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 presence of rhinosinusitis (paranasal sinus X-ray demonstrating mucosal thickening, or partial or complete opacification of the paranasal sinuses) presence of hypertension (systolic ≥ 180 mmHg or diastolic ≥ 100 mmHg) 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)) presence of neoplasm, severe systemic inflammation, other systemic disease that affects rhinitis history of drug allergy history of anaphylaxis for allergic tests pregnancy or lactation participation of other clinical study within the past 3 months.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SCRT group<br>3g, three times a day, each taken before or between meals | Drug: SCRT<br>* composed of eight herbs: Glycyrrhiza uralensis Fischer 1g Zingiber officinale Roscoe 0.5g Cinnamomum cassia Blume 0.2g, Ephedra sinica Stapf 0.5g, Pinellia ternata Breitenbach 2.67g, Paeonia lactiflora PALL 1g, Asiasarum sieboldi F. Maekawa 0.5g, Schisandra chinensis 2.67g (per 9g of granules)<br>|
| Placebo Comparator: placebo group<br>3g, three times a day, each taken before or between meals | Drug: Placebos<br>* is made of lactose, corn starch and caramel coloring, and has appearance, shape, weight, taste, and color similar to SCRT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Total Nasal Symptom score |  | At baseline, week 2, 4, 8, 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score |  | At baseline, week 2, 4, 8, 12 | 
| Change from baseline in Total serum IgE level |  | At baseline, week 4 | 
| Change from baseline in eosinophil count |  | At baseline, week 4 | 
| Change from baseline in cytokine level |  | At baseline, week 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Perennial Allergic Rhinitis, Herbal Medicine, Korean Medicine, So-Cheong-Ryong-Tang