Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID06462417

Study on the Efficacy and Safety of Oral Administration of Arbidol in the Treatment of Allergic Rhinitis Patients

Led by Zheng Liu · Updated on 2025-05-07

15

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

Sponsors

Z

Zheng Liu

Lead Sponsor

N

National Natural Science Foundation of China

Collaborating Sponsor

AI-Summary

What this Trial Is About

Allergic rhinitis (AR) is a non-infectious inflammatory condition of the nasal lining triggered by allergens and mediated by Immunoglobulin E. It is a common chronic respiratory disease that affects patients' quality of life and has economic impacts. Current treatments mainly involve nasal medications like corticosteroids and antihistamines, but many patients do not achieve satisfactory results. Arbidol, a medicine used for influenza, is being studied for its potential to inhibit molecular targets involved in AR's development to improve treatment effectiveness and convenience. Participants will receive oral Arbidol Hydrochloride Tablets at a dose of 0.2g per day for two weeks. This study includes one treatment group and does not involve placebo or masking. The treatment period lasts 14 days, during which researchers will analyze the effect of Arbidol on molecular and inflammation biomarkers related to AR. During the study, participants will undergo evaluations measuring protein and mRNA levels of molecular biomarkers in nasal cells and inflammation markers in nasal fluid at 14 days. Daily nasal symptom scores will also be recorded over the treatment period. Participants will follow the medication and visit schedule, record symptom scales, medication use, and any adverse events. The study runs until June 2025, with ongoing monitoring of efficacy and safety outcomes.

CONDITIONS

Brief Title

Efficacy and Safety of Arbidol in the Treatment of Allergic Rhinitis

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with allergic rhinitis according to the 2015 Tianjin diagnostic guidelines
  • At least two nasal symptoms (sneezing, runny nose, nasal itching, nasal congestion) rated moderate or above
  • Female participants not pregnant, breastfeeding, or planning pregnancy during the trial
  • No participation in other clinical trials within the past 3 months and agreement to avoid other trials during this study
  • Informed consent given and compliance with study procedures and medication
Not Eligible

You will not qualify if you...

  • Allergy to Arbidol
  • Abnormal liver or kidney function (ALT/AST >1.5 times normal, elevated creatinine)
  • Abnormal ECG parameters or bradycardia
  • Severe asthma or acute asthma attacks
  • Structural heart disease, severe hypertension, diabetes, hyperthyroidism, cancer, immunocompromise, or mental illness
  • Nasal polyps, severe deviated septum, sinusitis, or hypertrophic rhinitis
  • Participation in other clinical trials within the past 3 months
  • Pregnant, breastfeeding, or positive pregnancy test during trial
  • Drug abuse or alcoholism
  • Allergen-specific immunotherapy within 3 years
  • Positive infectious disease tests (hepatitis B, hepatitis C, AIDS, syphilis)
  • Other reasons per investigator's judgment

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 2 weeks

Participants receive Arbidol Hydrochloride Tablets for 2 weeks to evaluate its efficacy and safety in treating allergic rhinitis.

1 baseline visit and 1 follow-up visit

Trial Site Locations

Total: 2 locations

1

Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology

Wuhan, Hubei, China, 430000

Actively Recruiting

2

Department of ENT, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China, 430030

Actively Recruiting

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Research Team

Z

Zheng Liu, Doctor

M

Ming Zeng, Doctor

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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