Moxibustion Reduces Symptoms and Improves Quality of Life in Patients With Allergic Rhinitis

Allergic Rhinitis Clinical Trial

Official title:

The Therapeutic Effect and Standardization of Moxibustion in the Treatment of Allergic Rhinitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06173882
• Other study ID #: TCM for AR
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: August 1, 2025

Study information

• Verified date: December 2023
• Source: Henan University of Traditional Chinese Medicine
• Contact: Yang Xie, MD
• Phone: 0371-66248624
• Email: xieyanghn[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: August 1, 2025
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic

Intervention

Behavioral:
• Ordinary moxibustion volume group
Moxibustion for 10 minutes per acupoint
• First group of heavy moxibustion
Moxibustion for 20 minutes per acupoint
• Second groups of heavy moxibustion
Moxibustion for 30 minutes per acupoint

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Henan University of Chinese Medicine	Zhengzhou

Sponsors (1)

Lead Sponsor	Collaborator
Henan University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rhinitis VAS Visual Analog Scale(AR-VAS)	VAS will be used to evaluate the relief of rhinitis symptoms, with a total score of 0-10. The higher the score, the more severe the symptoms will be	Change from baseline VAS scores at week 0(before treatment),4 and 12.
Primary	Total nasal symptom scores(TNSS)	The main symptoms of allergic rhinitis, the higher the score, the worse the condition	Change from baseline TNSS scores at week 0(before treatment),4 and 12.
Secondary	Total non nasal symptom scores(TNNSS)	The nasal accompanying symptoms of allergic rhinitis, qualitative evaluation of the severity of the disease, with some indicating severity and none indicating milder severity	Change from baseline TNNSS scores at week0(before treatment),4 and 12.
Secondary	Rhino-conjunctivitis Quality of Life Questionnaire (RQLQ)	RQLQ consists of 28 items, including daily life (1-3), sleep (4-6), non nasal eye symptoms (7-13), life problems (14-16), nasal symptoms (17-20), eye symptoms (21-24), and emotions (25-28). In the 7-point system, 1 point is the best and 7 points are the worst.	Change from baseline RQLQ scores at week0(before treatment),4 and 12.
Secondary	Detection of serum IgE and IL-33 levels	Immunoglobulin IgE and serum inflammatory cytokine IL-33 levels	Week0(before treatment), week 4(after treatment).