Dose-effect relationship of ginger interposed moxibustion for allergic rhinitis: study protocol for a randomised, placebo-controlled and parallel clinical trial

Abstract

Introduction: Allergic rhinitis has a severe impact on patients' life quality, and the incidence rate keeps increasing. Moxibustion is widely used for treating allergic rhinitis, and quantity is the basis of moxibustion efficacy. The purpose of this study is to evaluate the relationship between the different quantities of moxibustion and the efficacy of moxibustion in the treatment of allergic rhinitis. This study may be conductive to the standardization of moxibustion and furnish the mechanism of dose-effect relationship of moxibustion with data and new ideas. Methods and analysis: This randomized, placebo-controlled clinical trial will include 33 patients with allergic rhinitis who will be randomly assigned into three groups in a 1:1:1 ratio：high-dose moxibustion group, low-dose moxibustion group and sham moxibustion control group. All groups will be treated once every other day, 20 days for one treatment course. And the patients will receive treatment for 2 courses with an interval of 2 days between courses. We will conduct a follow-up 30 days later after completion of treatments. The primary outcome measure is Total Nasal Symptom Score, carried out at baseline, 3, 6 and 10 weeks. Secondary outcome measure is Rhino Conjunctivitis Quality of Life Questionnaire, carried out at baseline, 6 and 10 weeks. Ethics and dissemination: This trail has been approved by the IRB of Shanghai TCM-Integrated Hospital, Shanghai University of TCM. The results of the trial will be disseminated in peer-reviewed journals. Trial registration number: ChiCTR2100050373; Pre-results.