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

The efficacy and safety of So-Cheong-Ryong-Tang for perennial allergic rhinitis : a double-blind, randomized, parallel-group, multi-center trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0002225

Enrollment

154

Registered

2017-02-13

Start date

2016-09-01

Completion date

Unknown

Last updated

2019-03-11

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

Conditions

None listed

Interventions

Drug : SCRT and Placebo, 3g, three times a day for 4 weeks, each taken before or between meals

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Total nasal symptom score (TNSS)	—

Secondary

Measure	Time frame
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	—

Countries

Korea, Republic of

Contacts

Public ContactYoume Ko

Kyung Hee University

ymymko84@gmail.com+82-2-961-9278

Outcome results