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

Phase 3

• Conditions: Perennial Allergic Rhinitis
• Interventions: Drug: SCRT; Drug: Placebos

• Registration Number: NCT03009136
• Lead Sponsor: Kyung Hee University Hospital at Gangdong

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-12-28
• Study Start: 2016-12-31
• Study First Submitted QC: 2017-01-03
• Study First Posted: 2017-01-04
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-12
• Last Update Posted: 2017-03-14
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 154

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SCRT group	SCRT	3g, three times a day, each taken before or between meals
placebo group	Placebos	3g, three times a day, each taken before or between meals

Primary Outcome Measures

Name	Time	Method
Change from baseline in Total Nasal Symptom score	At baseline, week 2, 4, 8, 12

Secondary Outcome Measures

Name	Time	Method
Change from baseline in eosinophil count	At baseline, week 4
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 cytokine level	At baseline, week 4

Trial Locations

Locations (1)

Kyung Hee University Hospital at Gangdong; 🇰🇷 Seoul, Korea, Republic of