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

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03009136

Enrollment

154

Registered

2017-01-04

Start date

2016-12-31

Completion date

2018-12-31

Last updated

2017-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perennial Allergic Rhinitis

Keywords

Perennial Allergic Rhinitis, Herbal Medicine, Korean Medicine, So-Cheong-Ryong-Tang

Brief summary

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

Interventions

DRUGSCRT

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)

DRUGPlacebos

is made of lactose, corn starch and caramel coloring, and has appearance, shape, weight, taste, and color similar to SCRT

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

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.

Design outcomes

Primary

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

Secondary

Measure	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

Countries

South Korea

Contacts

Primary ContactYoume Ko

iseeymk@gmail.com822-961-9278

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026