Clinical trial NCT03009136: Efficacy and Safety of So-Cheong-Ryong-Tang on Perennial Allergic Rhinitis
Official title: Efficacy and Safety of So-Cheong-Ryong-Tang on Perennial Allergic Rhinitis: Study Protocol for a Double-blind, Randomized, Parallel-group, Multi-center Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Perennial Allergic Rhinitis
Keywords: Perennial Allergic Rhinitis
Herbal Medicine
Korean Medicine
So-Cheong-Ryong-Tang
Lead sponsor: Kyung Hee University Hospital at Gangdong
Sponsor class: OTHER
Collaborators: name: Kyung Hee University Hospital
name: Pusan National University Hospital
name: Semyung University Affiliated Oriental Medical Hospital
name: DongGuk University
First posted: 2017-01-04
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in Total Nasal Symptom score
timeFrame: At baseline, week 2, 4, 8, 12
Secondary outcomes:
measure: Change from baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score
timeFrame: At baseline, week 2, 4, 8, 12
measure: Change from baseline in Total serum IgE level
timeFrame: At baseline, week 4
measure: Change from baseline in eosinophil count
timeFrame: At baseline, week 4
measure: Change from baseline in cytokine level
timeFrame: At baseline, week 4
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital at Gangdong
Study officials:
affiliation: Kyung Hee University Hospital at Gangdong
name: Minhee Kim
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim MH, Ko Y, Ahn JH, Yun Y, Yun MN, Ko SG, Choi I. Efficacy and safety of So-Cheong-Ryong-Tang in treatment of perennial allergic rhinitis: study protocol for a double-blind, randomised, parallel-group, multicentre trial. BMJ Open. 2017 Sep 27;7(9):e016556. doi: 10.1136/bmjopen-2017-016556.