A Randomized, Double-blind, Placebo-controlled Trial of Ganciclovir Capsules for Refractory Moderate-to-severe Allergic Rhinitis

What this Trial Is About

Researchers are studying the clinical efficacy and safety of ganciclovir capsules for treating refractory moderate-to-severe allergic rhinitis, a condition with persistent and difficult-to-treat symptoms. This randomized, double-blind, placebo-controlled trial aims to determine if ganciclovir can improve nasal symptoms and quality of life while assessing its safety. The study is conducted at a single center and includes participants diagnosed based on specific guidelines and symptom scores. Participants will be randomly assigned to receive either ganciclovir capsules or placebo capsules for two weeks, alongside background treatment with mometasone furoate nasal spray. The study has three phases: a screening phase lasting about two weeks, a two-week treatment phase with either ganciclovir or placebo plus nasal spray, and a two-week follow-up phase continuing nasal spray alone. Ganciclovir capsules are taken as two capsules twice daily, and nasal spray is used once daily throughout. During the study, participants will undergo assessments including nasal symptom scores, nasal secretion collection, blood tests, and safety evaluations such as vital signs and organ function tests before and after treatment. The main outcome is the rate of improvement in Total Nasal Symptom Scores (TNSS) from baseline to the end of treatment. Researchers will also monitor adverse events and analyze data to evaluate the treatment's effectiveness and safety. The total participation duration is about six weeks, including screening, treatment, and follow-up.

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