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

Abstract

ABSTRACTIntroductionAllergic 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 analysisThis 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 disseminationThis 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 numberChiCTR2100050373; Pre-results.Strengths and limitations of this studyA randomised, placebo-controlled and parallel clinical trial will be conducted to test if ginger interposed moxibustion would have curative effect on allergic rhinitis and reveal the preliminary dose-effect relationship of moxibustion.This study will set high-dose moxibustion group and low-dose moxibustion group to test if more quantities of ginger interposed moxibustion would achieve better therapeutic effects on allergic rhinitis.Further study should be carried out to test if the curative effect of ginger interposed moxibustion would be positively correlated with the quantities.