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RecruitingNCT06462417Updated May 7, 2025

Efficacy and Safety of Arbidol in the Treatment of Allergic Rhinitis

An interventional study of Arbidol in Allergic Rhinitis, sponsored by Zheng Liu. Recruiting at 2 sites in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-05-07.

Sponsored by Zheng Liu · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 4 months ago, but the record still lists the study as recruiting.
  • Started Jul 2024; still recruiting 2 years 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The most important treatment for AR is topical nasal medications (including nasal corticosteroids, nasal antihistamines, nasal decongestants, and nasal saline irrigation etc.), which are still limited. Arbidol may inhibit molecular targets involved in the pathogenesis of AR. This study intends to explore the effect of Arbidol in the treatment of allergic rhinitis and evaluate its efficacy and safety.

Read the detailed description

Allergic rhinitis (AR) is a non-infectious inflammatory disease of the nasal mucosa mediated by Immunoglobulin E after exposure to allergens. AR has become a major chronic inflammatory disease of the respiratory tract, which has a serious impact on the quality of life of patients and social economy. The most important treatment for AR is topical nasal medications (including nasal corticosteroids, nasal antihistamines, nasal decongestants, and nasal saline irrigation etc.). However, even if patients are treated completely according to the standard diagnosis and treatment strategy, a considerable number of patients still do not achieve satisfactory treatment results. Arbidol is a medicine for the prevention and treatment of influenza. Based on our previous laboratory data, Arbidol may inhibit molecular targets involved in the pathogenesis of AR. In order to make the treatment of AR more effective, timely and convenient, this study intends to explore the effect of Arbidol in the treatment of allergic rhinitis and evaluate its efficacy and safety.

02

Conditions studied

  • Allergic Rhinitis

Browse trials for

03

In context

Rhinitis, Allergic

717 studies on the registry are indexed under Rhinitis, Allergic; 94 are open to participants now.

This study's planned enrollment of 15 is below the median of 68 across 552 interventional studies indexed under Rhinitis, Allergic.

Browse Rhinitis, Allergic studies →

Lead sponsor

Zheng Liu is the lead sponsor of 7 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

    1. Patients with allergic rhinitis (in line with the diagnostic criteria of the "Guidelines for the Diagnosis and Treatment of Allergic Rhinitis (2015, Tianjin)" formulated by the Rhinology Group of the Otolaryngology-Head and Neck Surgery Branch of the Chinese Medical Association).
    1. At least 2 nasal symptoms are moderate or above (referring to sneezing, runny nose, nasal itching, nasal congestion with at least 2 symptoms ≥2 points).
    1. Female subjects are not pregnant or lactating and have no pregnancy and lactation plans during the trial medication period.
    1. The subject has not participated in other clinical trials in the previous three months and agrees not to participate in other clinical trials before reaching the endpoint of this trial.
    1. The subject/legally authorized representative understands the purpose and procedures of the trial and voluntarily signs the form, voluntarily participates in the study and complies with the study regulations, understands and complies with the medication dosage and follow-up plan, and correctly records the scale score, the number of medications, concomitant medication and adverse event records.

Exclusion criteria

Exclusion Criteria:

    1. Who are allergic to Arbidol.
    1. Patients with abnormal liver and kidney function ( and AST exceed the maximum limit of normal value by 1.5 times, and Cr exceeds the value).
    1. Patients with abnormal parameters and (PR>220ms, QRS>120ms, >450ms) and bradycardia.
    1. Patients with severe asthma or acute asthma exacerbations.
    1. Patients with structural heart disease, severe hypertension (blood pressure greater than 180/110mmHg), diabetes, hyperthyroidism, malignant tumors, immunocompromise, and mental illness. Patients with structural heart disease, severe hypertension (blood pressure greater than 180/110mmHg), diabetes, hyperthyroidism, malignant tumors, immunocompromise, and mental illness.
    1. Patients with nasal polyps, severe deviated nasal septum, sinusitis, and hypertrophic rhinitis.
    1. Who have participated in other clinical studies within 3 months.
    1. Women are pregnant or lactating, in childbearing age with positive blood pregnancy test, or have pregnancy and lactation plans during the trial medication.
    1. Drug abuse and alcoholism.
    1. Who have received allergen-specific immunotherapy within 3 years.
    1. Positive infectious disease screening ( surface antigen, antibody, AIDS antibody and treponema pallidum antibody).
    1. Who should not be included if there are other reasons in the opinion of the investigator.
Terms in these criteria, in plain language(8)

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.

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.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

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.

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.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (estimated)

Study arms

  • Experimental
    Arbidol

    Arbidol Hydrochloride Tablets

    Drug: Arbidol

Interventions

  • Arbidol Hydrochloride Tablets 0.2g/d for 2 weeks

    Also known as: Arbidol Hydrochloride

06

What researchers measure

Primary outcomes

  1. The protein level of molecular biomarkers in nasal epithelial cells

    The level of molecular biomarkers in nasal epithelial cells at baseline (day 0, prior to treatment), day 14 will be measured by western blotting.

    Time frame: 14 days

  2. The mRNA level of inflammation molecular biomarkers in nasal epithelial cells

    The relative mRNA level of inflammatory cytokines (including IL-4, IL-13, CCL11, CCL24, CCL26 etc.) in nasal epithelial cells at baseline (day 0, prior to treatment), day 14 will be measured by Real-time PCR.

    Time frame: 14 days

  3. The level of inflammation molecular biomarkers in nasal lavage fluid

    Investigate the change of inflammation molecular biomarkers using sample of nasal lavage fluid. Biomarkers including IL-4, IL-13, CCL11, CCL24, CCL26 and IgE etc. in nasal lavage fluid at day 7 day 14 were detected to compare the changes of molecular indices relative to baseline at day 0.

    Time frame: 14 days

Secondary outcomes

  1. Changes from baseline in daily total nasal symptom score (TNSS) during 2 weeks of treatment.

    The TNSS for allergic rhinitis was used to evaluate the rhinitis-related symptoms and quantity of life scores. Changes from baseline in daily total nasal symptom score (TNSS) during 2 weeks of treatment. The Total Nasal Symptom Score (TNSS) is the sum of four symptom scores, rhinorrhea, nasal congestion, nasal itching, and sneezing, where each symptom is scored on a scale of 0 to 3.

    Time frame: 14 days

07

Study locations

2 of 2 sites recruiting
  • Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
    Wuhan, Hubei 430000, China
    Recruiting
    • Zeng Ming, chief physician · Contactzmsx77@163.com · 86-027-83663807
  • Department of ENT, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
    Wuhan, Hubei 430030, China
    Recruiting
    • Zheng Liu, doctor · Contactzhengliuent@hotmail.com · 86 027 83663807
    • Wang, Doctor · Contact
    • Zheng Liu, doctor · Principal investigator
    • Heng Wang, doctor · Principal investigator
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2024 (actual). Primary completion is estimated for Jun 2025, 11 months after the start.

Of 66 non-industry interventional studies with no phase under Rhinitis, Allergic, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 28. This study's planned 11 months is below that.

Counting every sponsor, half of 87 studies reached it within 11 months; a quarter within 4 and three quarters within 27.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 12, 2024
First posted
Jun 17, 2024
StartActual
Jul 11, 2024
Primary completionEst.
Jun 30, 2025
CompletionEst.
Jun 30, 2025
Last update
May 7, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 7, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06462417
Lead sponsor
Zheng Liu
Collaborators
National Natural Science Foundation of China
Responsible party
Zheng Liu (Professor of Otolaryngology-Head & Neck Surgery Vice Director Department of ENT Tongji Hospital Tongji Medical College Huazhong University of Science and Technology, Huazhong University of Science and Technology) — Sponsor-investigator
First posted
Jun 17, 2024
Start date
Jul 11, 2024
Primary completion
Jun 30, 2025 (estimated)
Completion
Jun 30, 2025 (estimated)
Last update
May 7, 2025

Study contacts

Zheng Liu, Doctor
Contact
zhengliuent@hotmail.com
86 027 83663807
Ming Zeng, Doctor
Contact
zmsx77@163.com
86 027 83663807
Zheng Liu, Doctor
study chair · Tongji Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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