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

Min-Hee Kim, Youme Ko, Jin-Hyang Ahn, Younghee Yun, Mi-Na Yun, Seong-Gyu Ko, Inhwa Choi, Min-Hee Kim, Youme Ko, Jin-Hyang Ahn, Younghee Yun, Mi-Na Yun, Seong-Gyu Ko, Inhwa Choi

Abstract

Introduction: So-Cheong-Ryong-Tang (SCRT) is a herbal medicine widely used in traditional medicine for treating allergic rhinitis (AR). In animal studies, SCRT has suppressed the progression of AR. The main purpose of this study is to assess the efficacy and safety of the SCRT for the treatment of perennial allergic rhinitis (PAR) and discover the underlying mechanisms resulting in anti-inflammatory effects in humans.

Methods and analysis: We will conduct a double-blind, randomised, placebo-controlled, parallel-group, multicentre trial of Korean adults with PAR. For the study, 156 subjects with PAR will be recruited. The trial will consist of a 4-week oral administration of SCRT or placebo with two visits at 2-week intervals and an 8-week follow-up period with two visits at 4-week intervals. The primary outcome is a change in the total nasal symptoms score. The secondary outcomes include changes in the Rhinoconjunctivitis Quality of Life Questionnaire score, total serum IgE and cytokines levels.

Ethics and dissemination: This study was approved by the Institutional Review Board at each research centre (name of each centres and approval numbers): Kyung Hee University Hospital at Gangdong (KHNMC-OH-IRB 2015-04-009), Kyung Hee University Medical Centre (KOMCIRB-160321-HRBR-011), Pusan National University Hospital (2016-004), Dongguk University Medical Centre (2016-03) and Semyung University hospital (2016-01). This result will be published in a peer-reviewed journal.

Trial registration number: NCT03009136; Pre-results.

Keywords: allergy; complementary medicine; otolaryngology.

Conflict of interest statement

Competing interests: None declared.

© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Figures

Figure 1
Figure 1
Study design flowchart. SCRT, So-Cheong-Ryong-Tang.
Figure 2
Figure 2
Nasal endoscopy index for pattern identification.

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