Huandao Conditioning Application for Allergic Rhinitis Treatment

NCT ID: NCT06818526

Last Updated: 2025-02-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 95 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2026-12-31

Brief Summary

The goal of this clinical trial is to learn if the Huandao Conditioning Application works to treat allergic rhinitis in adults. It will also learn about the safety of this application. The main questions it aims to answer are:

Does the Huandao Conditioning Application improve allergic rhinitis symptoms as measured by the Rhinitis Control Assessment Test (RCAT) and nasal airway resistance tests? What medical problems do participants have when using the Huandao Conditioning Application?

Researchers will compare the therapeutic version of the application to a placebo version (a look-alike application that contains no therapeutic effect) to see if the Huandao Conditioning Application works to treat allergic rhinitis.

Participants will:

Use either the therapeutic or placebo version of the application daily for 1 week in Phase 1 Take a 2-week break with no application use Use the opposite version of the application daily for 1 week in Phase 2 Visit the clinic at the beginning and end of each phase for checkups and tests Complete symptom assessment questionnaires before each application use and 1-2 hours after use Be monitored for any adverse reactions throughout the study period

Detailed Description

Detailed Description:

Allergic rhinitis (AR) is a chronic respiratory condition affecting 15% of the global population. The study investigates a novel mobile application-based intervention utilizing Traditional Chinese Medicine (TCM) meridian theory.

Study Design:

Randomized, double-blind, placebo-controlled crossover trial Two 1-week treatment periods separated by 2-week washout 1:1 randomization to active/placebo app sequence

Intervention Details:

Therapeutic app: Energy-balancing effects based on TCM meridians Placebo app: Visually identical without therapeutic properties Daily 5-10 minute self-administered sessions Symptom tracking before and 1-2 hours post-application

Assessment Schedule:

Baseline: RCAT, allergen screening, nasal resistance Treatment weeks: Daily symptom monitoring, Day 4 phone follow-up End of phases: RCAT, nasal resistance, adverse events Study completion: Additional allergen screening

Target Population:

95 participants Recruitment via posters at Hualien Tzu Chi Hospital Expected 70 evaluable subjects for analysis

This study aims to evaluate the efficacy and safety of a TCM-based digital therapeutic for AR symptom management.

Conditions

Allergic Rhinitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo Huandao Conditioning Application

Group Type: PLACEBO_COMPARATOR

Placebo Huandao Conditioning App

Intervention Type: DEVICE

Mobile Application Intervention: Placebo Huandao Conditioning App for Allergic Rhinitis Treatment

Type: Software Application (Mobile App) Purpose: Energy balancing therapy based on traditional Chinese medicine meridian theory Application Method: Self-administered via smartphone Duration: 5-10 minutes per session

Therapeutic Huandao Conditioning Application

Group Type: EXPERIMENTAL

Huandao Conditioning Application

Intervention Type: DEVICE

Mobile Application Intervention: Huandao Conditioning App for Allergic Rhinitis Treatment

Type: Software Application (Mobile App) Purpose: Energy balancing therapy based on traditional Chinese medicine meridian theory Application Method: Self-administered via smartphone Duration: 5-10 minutes per session

Interventions

Huandao Conditioning Application

Mobile Application Intervention: Huandao Conditioning App for Allergic Rhinitis Treatment

Type: Software Application (Mobile App) Purpose: Energy balancing therapy based on traditional Chinese medicine meridian theory Application Method: Self-administered via smartphone Duration: 5-10 minutes per session

Intervention Type: DEVICE

Placebo Huandao Conditioning App

Mobile Application Intervention: Placebo Huandao Conditioning App for Allergic Rhinitis Treatment

Type: Software Application (Mobile App) Purpose: Energy balancing therapy based on traditional Chinese medicine meridian theory Application Method: Self-administered via smartphone Duration: 5-10 minutes per session

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years
• RCAT score < 21
• Positive allergen screening (> 0.35 KU/L for house dust, microbial, or pet dander)
• Capable of operating mobile app and completing follow-up

Exclusion Criteria

• Recent diagnosis, active treatment, or recurrence risk of head/neck cancer
• Current or previous immunotherapy
• Any condition that may compromise participant safety or interfere with trial assessment per investigator judgment

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Buddhist Tzu Chi General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Lian-Jie Lin, M.D.

Role: CONTACT

zxcv1234527@hotmail.com

+886 038561825 ext. 13558

Other Identifiers

IRB113-209-A

Identifier Type: -

Identifier Source: org_study_id