Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06436534
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-05-24
Brief Title:
Efficacy and Safety of Ganciclovir Capsules in the Treatment of Refractory Moderate-to-severe Allergic Rhinitis
Sponsor:
Wuhan Union Hospital China
Organization:
Wuhan Union Hospital China
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Single-center Clinical Trial of Ganciclovir Capsules in the Treatment of Refractory Moderate-to-severe Allergic Rhinitis
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
Ganciclovir GCV is clinically used for the treatment of DNA viral infections In clinical practice we have found that patients with refractory AR have improved nasal symptoms after oral administration of ganciclovir In clinical practice we have found that patients with refractory AR have improved nasal symptoms after oral administration of ganciclovir To further explore the role of GCV in the treatment of refractory allergic rhinitis we have conducted an interventional non-randomised cohort study of GCV for refractory AR The results found that 65 of all refractory AR patients included in the observation were effectively treated with GCV Based on the previous discovery in the clinical practice the conjecture is proposed that ganciclovir may improve symptoms in allergic rhinitis patients in particular the patients with refractory moderate-to-severe allergic rhinitis Thus the randomized double-blind placebo-controlled clinical trial was designed to explore the validity of this hypothesis
The research involves three phases screening phaseDay-1420baseline Day1treatment phase Day114follow-up phase Day1428
In the screening phase anterior rhinoscopy serum specific IgE test skin prick test total nasal symptom scores TNSS visual analogue scale VAS scores Allergic Rhinitis Control Test ARCT score will be performed for participants Participants who meet the inclusion and exclusion criteria will enter the treatment phase and receive the medication for two weeks At the end of the treatment researchers will follow participants for two weeks to track efficacy and safety
Researchers will collect participants symptom scores nasal secretions and blood The biological specimens will be used to test for indicators that support the determination of therapeutic efficacy Vital signs blood routine examination urine routines liver function test kidney function test and electrocardiograms will be measured for participants before and after treatment to assess the safety of ganciclovir
The data collected will be statistically analyzed to examine the clinical efficacy and safety of ganciclovir capsules in the treatment of refractory moderate-to-severe allergic rhinitis
The research involves three phases screening phaseDay-1420baseline Day1treatment phase Day114follow-up phase Day1428
In the screening phase anterior rhinoscopy serum specific IgE test skin prick test total nasal symptom scores TNSS visual analogue scale VAS scores Allergic Rhinitis Control Test ARCT score will be performed for participants Participants who meet the inclusion and exclusion criteria will enter the treatment phase and receive the medication for two weeks At the end of the treatment researchers will follow participants for two weeks to track efficacy and safety
Researchers will collect participants symptom scores nasal secretions and blood The biological specimens will be used to test for indicators that support the determination of therapeutic efficacy Vital signs blood routine examination urine routines liver function test kidney function test and electrocardiograms will be measured for participants before and after treatment to assess the safety of ganciclovir
The data collected will be statistically analyzed to examine the clinical efficacy and safety of ganciclovir capsules in the treatment of refractory moderate-to-severe allergic rhinitis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None