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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 95
- Primary Endpoint
- RCAT scores
Study Overview
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Placebo Huandao Conditioning Application
Intervention: Placebo Huandao Conditioning App (Device)
Therapeutic Huandao Conditioning Application
Intervention: Huandao Conditioning Application (Device)
Outcomes
Primary Outcomes
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
- Change in nasal airway resistance(Each phase Day 1 and Day 8)