An interventional study of Ganciclovir Oral Capsule and Ganciclovir Simulant Oral Capsule in Rhinitis, Allergic, sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-07-13.
Sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Not applicable, Interventional, and Treatment
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:
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.
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 phase(Day-14±2\~0)；baseline (Day1)；treatment phase (Day1\~14)；follow-up phase (Day14\~28).
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.
717 studies on the registry are indexed under Rhinitis, Allergic; 94 are open to participants now.
This study's planned enrollment of 50 is below the median of 68 across 552 interventional studies indexed under Rhinitis, Allergic.
Browse Rhinitis, Allergic studies →Union Hospital, Tongji Medical College, Huazhong University of Science and Technology is the lead sponsor of 181 studies on the registry; 144 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Screening phase(Day -14±2\~0):Mometasone furoate nasal spray(50μg/spray), take 1 spray once a day. Treatment phase(Day 1\~14±2): Ganciclovir capsules(250mg), take 2 capsules twice a day + Mometasone furoate nasal spray(50μg/spray), take 1 spray once a day. Follw-up phase(Day 14\~28±2):Mometasone furoate nasal spray(50μg/spray), take 1 spray once a day.
Drug: Ganciclovir Oral Capsule · Drug: Mometasone Nasal
Screening phase(Day -14±2\~0):Mometasone furoate nasal spray(50μg/spray), take 1 spray once a day. Treatment phase(Day 1\~14±2): Ganciclovir simulant capsules(0mg), take 2 capsules twice a day + Mometasone furoate nasal spray(50μg/spray), take 1 spray once a day. Follw-up phase(Day 14\~28±2):Mometasone furoate nasal spray(50μg/spray), take 1 spray once a day.
Drug: Ganciclovir Simulant Oral Capsule · Drug: Mometasone Nasal
2-week treatment phase：Ganciclovir capsules(250mg), take 2 capsules twice a day
Also known as: Ganciclovir
2-week treatment phase：Ganciclovir simulant capsules(0mg), take 2 capsules twice a day
Also known as: Ganciclovir
From screening phase to follow-up phase：Mometasone furoate aqueous nasal spray(50μg/spray), take 1 spray once a day
Also known as: Mometasone furoate aqueous nasal spray, NASONEX, Mometasone furoate nasal spray
Rate of improvement in TNSS scores
After 2 weeks of treatment phase, the investigator assess the rate of change in the difference in TNSS from baseline. Calculated as (total post-treatment symptom score - total pre-treatment symptom score)/total pre-treatment symptom score × 100%.
Time frame: From baseline to the end of treatment phase(2 weeks)
Total effective rate
Participants with a \>30% decrease in total nasal symptom scores (TNSS) after 2 weeks of treatment are considered effective. The percentage of participants effective on treatment will be assessed as total effective rate.
Time frame: From baseline to the end of treatment phase(2 weeks)
Rate and absolute value of change in TNSS and four subdomains.
TNSS assesses symptom severity in four subdomains consisting of sneezing, rhinorrhea, nasal itching, and nasal obstruction. Each subdomain is rated on a scale of 0 (no symptoms) to 3 (severe symptoms that are difficult to tolerate and interfere with daily activity). The overall TNSS score is the sum of all four symptoms resulting in a maximum score of 12. After the treatment phase, evaluate the rate and absolute value of change in TNSS and four subdomains from baseline.
Time frame: From baseline to the end of treatment phase(2 weeks)
Rate and absolute value of change in visual analogue scale (VAS) scores.
The VAS ranges from 0 to 100. A score of 0 corresponds to no symptoms and 100 corresponds to the worst symptoms. After the treatment phase, evaluate the rate and absolute value of change in VAS scores from baseline.
Time frame: From baseline to the end of treatment (2 weeks)
Rate and absolute value of change in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
RQLQ is a validated QOL instrument consisting of 28 questions in seven domains (limited activity, sleep, practical problems, nasal symptoms, eye symptoms, emotional function, and non-nose/eye or other symptoms). Each domain is graded from zero (not impaired at all) to six (severely impaired), and the overall RQLQ is the mean score of all 28 responses. After the treatment phase, evaluate the rate and absolute value of change in RQLQ scores from baseline.
Time frame: From baseline to the end of treatment (2 weeks)
Change in mean TNSS during a 2-week administration period
Participants assess the TNSS score on a daily basis. TNSS assesses symptom severity in four subdomains consisting of sneezing, rhinorrhea, nasal itching, and nasal obstruction. Each subdomain is rated on a scale of 0 (no symptoms) to 3 (severe symptoms that are difficult to tolerate and interfere with daily activity). The overall TNSS score is the sum of all four symptoms resulting in a maximum score of 12. After the treatment phase, evaluate the change in mean TNSS during a 2-week administration period from baseline.
Time frame: During the 2-week administration period
Rate and absolute value of change in TNSSand four subdomains, VAS, RQLQ scores in follow-up phase
After the follow-up phase, evaluate the rate and absolute value of change in TNSS, VAS, RQLQ scores from baseline.
Time frame: From baseline to the end of follow-up phase (4 weeks)
Plan to share: No
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Studies of the drug tested here: Ganciclovir
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