Actively Recruiting
Efficacy and Safety of Ganciclovir Capsules in the Treatment of Refractory Moderate-to-severe Allergic Rhinitis
Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Updated on 2025-07-10
50
Participants Needed
1
Research Sites
101 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy and Safety of Ganciclovir Capsules in the Treatment of Refractory Moderate-to-severe Allergic Rhinitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 18 and 65 years.
- Diagnosed with moderate-to-severe perennial allergic rhinitis with Allergic Rhinitis Control Test (ARCT) score less than 20.
- Total Nasal Symptom Score (TNSS) of 6 or higher, or at least two nasal symptoms rated 2 or higher at both screening and randomization, with less than 30% improvement between screening and randomization.
- Allergic to dust mites or other perennial allergens.
- Voluntarily agree to participate and sign informed consent.
You will not qualify if you...
- Hypersensitivity to ganciclovir capsules or their ingredients.
- Symptoms of viral infection, fever, or systemic symptoms within the past 2 weeks.
- Pregnant, breastfeeding, or planning pregnancy during the study.
- Severe neutropenia or thrombocytopenia.
- Respiratory infections, sinusitis, dry or atrophic rhinitis, severe nasal septum deviation, or asthma.
- Severe heart, lung, liver, or kidney disease.
- Recent or planned live or attenuated vaccine within 4 weeks before or after the study.
- History or positive test for HIV infection.
- Current or chronic hepatitis B or C infection.
- Cirrhosis or chronic hepatitis.
- Active or high risk of parasitic infections.
- History or suspected immunosuppression or frequent serious infections.
- History of cancer within 5 years.
- Severe comorbidities affecting study participation.
- Neurological or psychiatric disorders preventing cooperation.
- Legally recognized disabilities affecting participation.
- History of alcohol or drug abuse.
- Participation in other clinical trials within 3 months before screening.
- Any other reasons deemed inappropriate by the researchers.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Wuhan Union Hospital
Wuhan, Hubei, China, 430022
Actively Recruiting
Research Team
J
Jianjun Chen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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