Socheongryong-tang for improving nasal symptoms associated with allergic rhinitis: A study protocol for a randomized, open-label, cetirizine controlled, clinical trial

INTRODUCTION: Socheongryong-tang (SCRT) is an herbal medicine with anti-inflammatory and anti-allergic properties, commonly used in East Asian countries to reduce rhinitis symptoms. There have been several clinical studies of its effects on allergic rhinitis (AR), but no trials comparing it with conventional treatment. We present the protocol for a feasibility trial to assess the safety and clinical effectiveness of SCRT in AR in comparison with cetirizine. METHODS AND ANALYSIS: This is a randomized, open-label, cetirizine-controlled clinical trial. A total of 30 AR patients who have signed informed consent forms will be recruited and randomly assigned to SCRT or cetirizine groups at a 1:1 ratio. The participants will visit the clinical research center every week and receive SCRT granules or cetirizine tablets. SCRT will be taken twice daily, cetirizine will be taken once daily, and treatment medication will be taken for 2 weeks. Data will be collected at baseline, at week 2, and at week 4 after random allocation. The primary outcome will be the mean change in the total nasal symptom score from baseline to week 2. Secondary outcome measures will include the mini Rhinoconjunctivitis Quality of Life Questionnaire and total serum immunoglobulin E. To assess the safety of SCRT, a liver and renal function test will be conducted before and after treatment, and the participants will be asked about any occurrence of adverse events at every visit. The recruitment rate, completion rate, and medication adherence will also be calculated to assess feasibility. DISCUSSION: The findings of this study are expected to provide the basis for a full-scale randomized controlled trial to confirm the safety and effectiveness of SCRT for the treatment of nasal symptoms in patients with AR patients not controlled by conventional therapy. TRIAL REGISTRATION: This study has been registered at the Korean National Clinical Trial Registry, Clinical Research Information Service (KCT0002380).