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

December 15, 2023 updated by: Henan University of Traditional Chinese Medicine

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Zhengzhou, China
        • Recruiting
        • the First Affiliated Hospital of Henan University of Chinese Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Ordinary moxibustion volume group
Behavioral: Ordinary moxibustion volume group
Moxibustion for 10 minutes per acupoint
Experimental: First group of heavy moxibustion
Behavioral: First group of heavy moxibustion
Moxibustion for 20 minutes per acupoint
Experimental: Second groups of heavy moxibustion
Behavioral: Second groups of heavy moxibustion
Moxibustion for 30 minutes per acupoint

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rhinitis VAS Visual Analog Scale（AR-VAS）
Time Frame: Change from baseline VAS scores at week 0(before treatment)，4 and 12.
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.
Total nasal symptom scores（TNSS）
Time Frame: Change from baseline TNSS scores at week 0(before treatment)，4 and 12.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total non nasal symptom scores（TNNSS）
Time Frame: Change from baseline TNNSS scores at week0(before treatment)，4 and 12.
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.
Rhino-conjunctivitis Quality of Life Questionnaire （RQLQ）
Time Frame: Change from baseline RQLQ scores at week0(before treatment)，4 and 12.
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.
Detection of serum IgE and IL-33 levels
Time Frame: Week0(before treatment), week 4（after treatment）.
Immunoglobulin IgE and serum inflammatory cytokine IL-33 levels
Week0(before treatment), week 4（after treatment）.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henan University of Traditional Chinese Medicine

Investigators

  • Study Director: Yang Xie, MD, Henan University of Traditonal Chinese Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2022

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

December 5, 2023

First Submitted That Met QC Criteria

December 15, 2023

First Posted (Estimated)

December 18, 2023

Study Record Updates

Last Update Posted (Estimated)

December 18, 2023

Last Update Submitted That Met QC Criteria

December 15, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TCM for AR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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