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Huandao Conditioning Application for Allergic Rhinitis Treatment

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06818526
Enrollment
95
Registered
2025-02-10
Start date
2025-03-01
Completion date
2026-12-31
Last updated
2025-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Rhinitis

Keywords

allergic rhinitis

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.

Interventions

DEVICEHuandao 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

DEVICEPlacebo 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

Sponsors

Buddhist Tzu Chi General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
RCAT scoresChange 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

MeasureTime frameDescription
Change in nasal airway resistanceEach phase Day 1 and Day 8Changes in nasal airway resistance measured by rhinomanometry

Contacts

Primary ContactLian-Jie Lin, M.D.
zxcv1234527@hotmail.com+886 038561825

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026