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

Kyung Hee University

Status and phase: Unknown; Phase 3

Conditions: Perennial Allergic Rhinitis

Treatments: Drug: SCRT; Drug: Placebos

Study type: Interventional

Funder types: Other

Identifiers

NCT03009136

ISEE_2015_SCRT

Details and patient eligibility

About

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

Enrollment: 154 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. age 18-60 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
9. participation of other clinical study within the past 3 months.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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154 participants in 2 patient groups, including a placebo group

SCRT group

Experimental group

Description:

3g, three times a day, each taken before or between meals

Treatment:

Drug: SCRT

placebo group

Placebo Comparator group

Description:

3g, three times a day, each taken before or between meals

Treatment:

Drug: Placebos