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Recruiting NCT06436534

Efficacy and Safety of Ganciclovir Capsules in the Treatment of Refractory Moderate-to-severe Allergic Rhinitis

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Trial Parameters

Condition Rhinitis, Allergic
Sponsor Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study Type INTERVENTIONAL
Phase N/A
Enrollment 50
Sex ALL
Min Age 18 Years
Max Age 65 Years
Start Date 2024-05-24
Completion 2026-03
Interventions
Ganciclovir Oral CapsuleGanciclovir Simulant Oral CapsuleMometasone Nasal

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Brief Summary

The goal of this clinical trial is to learn about the clinical efficacy and safety of ganciclovir (GCV) capsules in the treatment of refractory moderate-to-severe allergic rhinitis. The main questions it aims to answer are: 1. Whether ganciclovir improve nasal symptoms and life quality in patients with refractory moderate-to-severe allergic rhinitis. 2. Whether ganciclovir is safe for the treatment of allergic rhinitis. Participants with refractory moderate-to-severe allergic rhinitis will be included in the trial based on the inclusion and exclusion criteria, and randomized into experimental and control groups. The two groups will be treated with blinded ganciclovir capsules or placebo for two weeks, with the background therapy of mometasone furoate aqueous nasal spray. A placebo is a look-alike capsule that contains no active drug. Nasal symptom scores, nasal secretions, blood samples and adverse events will be collected during the visits. Researchers will compare the experimental and control groups to see whether ganciclovir improve symptoms and is safe for the treatment of refractory moderate-to-severe allergic rhinitis.

Eligibility Criteria

Inclusion Criteria: 1. Aged between 18 and 65 years. 2. Diagnosed with moderate-to-severe perennial allergic rhinitis based on Chinese guideline for diagnosis and treatment of allergic rhinitis (2022, revision) with Allergic Rhinitis Control Test (ARCT) score \<20. 3. Total Nasal Symptom Score (TNSS) ≥6 or at least two of the four subdomains(sneezing, rhinorrhea, nasal itching, and nasal obstruction) ≥2 at the time of both screening and randomization. And the improvement in TNSS was assessed as \< 30% at randomization compared to screening. 4. The participant is allergic to dust mites or other perennial allergens 5. Voluntarily participate in the clinical trial and sign the informed consent. Exclusion Criteria: 1. Participants with hypersensitivity to ganciclovir capsules and its excipients. 2. Have symptoms of viral infection, fever and other systemic symptoms in the past 2 weeks. 3. Pregnant or lactating women and participants who have pregnancy plan during the study period. 4. Parti

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