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

NCT06173882 | Unknown DMC

• 1 other identifier: TCM for AR
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Conditions

Allergic Rhinitis

Keywords

allergic rhinitis; moxibustion; body surface temperature

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (3)

• Total non nasal symptom scores（TNNSS）

  Change from baseline TNNSS scores at week0(before treatment)，4 and 12.

• Rhino-conjunctivitis Quality of Life Questionnaire （RQLQ）

  Change from baseline RQLQ scores at week0(before treatment)，4 and 12.

• Detection of serum IgE and IL-33 levels

  Week0(before treatment), week 4（after treatment）.

Study Arms (3)

Ordinary moxibustion volume group

PLACEBO COMPARATOR

Behavioral: Ordinary moxibustion volume group

First group of heavy moxibustion

EXPERIMENTAL

Behavioral: First group of heavy moxibustion

Second groups of heavy moxibustion

EXPERIMENTAL

Behavioral: Second groups of heavy moxibustion

Interventions

Ordinary moxibustion volume group BEHAVIORAL

Moxibustion for 10 minutes per acupoint

Ordinary moxibustion volume group

First group of heavy moxibustion BEHAVIORAL

Moxibustion for 20 minutes per acupoint

First group of heavy moxibustion

Second groups of heavy moxibustion BEHAVIORAL

Moxibustion for 30 minutes per acupoint

Second groups of heavy moxibustion

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Henan University of Traditional Chinese Medicine: lead

Study Sites (1)

The First Affiliated Hospital of Henan University of Chinese Medicine

Zhengzhou, China

RECRUITING

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Yang Xie, MD

  Henan University of Traditonal Chinese Medicine

  STUDY DIRECTOR

Central Study Contacts

Yang Xie, MD

CONTACT

0371-66248624; xieyanghn@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: December 18, 2023
• Study Start: August 1, 2022
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2025
• Last Updated: December 18, 2023

Record last verified: 2023-12

Locations

CN (1)