Huandao Conditioning Application for Allergic Rhinitis Treatment

February 11, 2025 updated by: Buddhist Tzu Chi General Hospital

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

95

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo Huandao Conditioning Application
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
Experimental: Therapeutic Huandao Conditioning Application
Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in nasal airway resistance
Time Frame: Each phase Day 1 and Day 8
Changes in nasal airway resistance measured by rhinomanometry
Each phase Day 1 and Day 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Buddhist Tzu Chi General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2025

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

February 5, 2025

First Submitted That Met QC Criteria

February 5, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 11, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB113-209-A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Allergic Rhinitis

Clinical Trials on Placebo Huandao Conditioning App

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahamas

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe