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NCT Number: NCT06818526

Huandao Conditioning Application for Allergic Rhinitis Treatment

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Huandao Conditioning Application

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

Placebo Huandao Conditioning App

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

Primary outcomes

  1. RCAT scores

    Time frame: Change in RCAT scores [Time Frame: 4 weeks] Baseline (Day 1) End of Phase 1 (Day 8) Start of Phase 2 (Day 22) End of study (Day 29)

    Change in RCAT scores from baseline

Secondary outcomes

  1. Change in nasal airway resistance

    Time frame: Each phase Day 1 and Day 8

    Changes in nasal airway resistance measured by rhinomanometry

Study contacts

Contact information is provided by the study sponsor or research team.

Lian-Jie Lin, M.D.

CONTACT

[email protected]

+886 038561825 ext. 13558

Sponsors and collaborators

Lead sponsor

Buddhist Tzu Chi General Hospital

Other

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled, Two-Period Crossover Study to Evaluate the Efficacy and Safety of Huandao Conditioning Application in Adults with Allergic Rhinitis

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Feb 10, 2025
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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