Clinical trial NCT06173882: Moxibustion Reduces Symptoms and Improves Quality of Life in Patients With Allergic Rhinitis
Official title: The Therapeutic Effect and Standardization of Moxibustion in the Treatment of Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Allergic Rhinitis
Keywords: allergic rhinitis
moxibustion
body surface temperature
Lead sponsor: Henan University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2023-12-18
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this randomized controlled clinical trial is to compare the therapeutic effect of moxibustion on allergic rhinitis. The main questions it aims to answer are:

Based on randomized controlled trials, verify the effectiveness of moxibustion in treating allergic rhinitis Based on a real-time monitoring system for human surface temperature, discuss the differences in therapeutic effects of different moxibustion doses on allergic rhinitis

Detailed description: Allergic rhinitis has a high incidence and is difficult to cure, seriously affecting the quality of life of patients Compare the effects of different moxibustion durations on the clinical efficacy and body surface temperature of patients with allergic rhinitis, and preliminarily explore the impact of different moxibustion doses on the efficacy of heavy moxibustion treatment for allergic rhinitis, providing evidence-based basis for clinical practice.

Eligibility criteria: Inclusion criteria

* Those who meet the diagnostic criteria of Chinese and Western medicine for AR;
* Age range from 18 to 75 years old, regardless of gender;
* Patients and their families are informed and agree to the study.

Exclusion criteria

* Those who are undergoing other traditional Chinese medicine external treatment methods;
* Those who have taken traditional Chinese medicine recently or during treatment;
* Individuals who are allergic to heavy moxibustion smoke and dust;
* Individuals with concomitant bronchial asthma or other respiratory system diseases;
* Patients with severe skin diseases or ulcers in the local area where moxibustion is applied;
* Pregnant and lactating patients;
* Patients with severe diseases of important organs such as the heart, liver, lungs, and kidneys;
* Those who are unable to receive treatment according to regulations due to inconvenience in work, study, transportation, or personal activities

Primary outcomes:
measure: Rhinitis VAS Visual Analog Scale（AR-VAS）
timeFrame: Change from baseline VAS scores at week 0(before treatment)，4 and 12.
measure: Total nasal symptom scores（TNSS）
timeFrame: Change from baseline TNSS scores at week 0(before treatment)，4 and 12.
Secondary outcomes:
measure: Total non nasal symptom scores（TNNSS）
timeFrame: Change from baseline TNNSS scores at week0(before treatment)，4 and 12.
measure: Rhino-conjunctivitis Quality of Life Questionnaire （RQLQ）
timeFrame: Change from baseline RQLQ scores at week0(before treatment)，4 and 12.
measure: Detection of serum IgE and IL-33 levels
timeFrame: Week0(before treatment), week 4（after treatment）.
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Henan University of Chinese Medicine
Study officials:
affiliation: Henan University of Traditonal Chinese Medicine
name: Yang Xie, MD
role: STUDY_DIRECTOR
References: