Huandao Conditioning Application for Allergic Rhinitis Treatment

NCT06818526 | Not Yet Recruiting

• 1 other identifier: IRB113-209-A
• Study Type: interventional
• Target: 95
• Locations: 0 countries
• Sites: N/A

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

Conditions

Allergic Rhinitis

Keywords

allergic rhinitis

Outcome Measures

Primary Outcomes (1)

• RCAT scores

  Change in RCAT scores from baseline

  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)

Secondary Outcomes (1)

• Change in nasal airway resistance

  Each phase Day 1 and Day 8

Study Arms (2)

Placebo Huandao Conditioning Application

PLACEBO COMPARATOR

Device: Placebo Huandao Conditioning App

Therapeutic Huandao Conditioning Application

EXPERIMENTAL

Device: Huandao Conditioning Application

Interventions

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

Therapeutic Huandao Conditioning Application

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

Placebo Huandao Conditioning Application

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Buddhist Tzu Chi General Hospital: lead

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Lian-Jie Lin, M.D.

CONTACT

+886 038561825; zxcv1234527@hotmail.com

Study Design

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

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: February 10, 2025
• Study Start: March 1, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share