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A randomized controlled study on the safety and efficacy of a ribavirin spray for the treatment of allergic rhinitis

A randomized controlled study on the safety and efficacy of a ribavirin spray for the treatment of allergic rhinitis

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400082642
Enrollment
Unknown
Registered
2024-04-02
Start date
2024-04-11
Completion date
Unknown
Last updated
2025-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Rhinitis

Interventions

Experimental group:Using ribavirin spray, administer 1 spray per nostril, twice daily, for a total of 4 weeks.
Control group:Using placebo nasal spray, administer 1 spray per nostril, twice daily, for a total of 4 weeks.

Sponsors

The Second Affiliated Hospital of Naval Medical University (Changzheng Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 65 years old. 2. Meet the diagnostic criteria for allergic rhinitis as outlined in the "Chinese Guidelines for the Diagnosis and Treatment of Allergic Rhinitis" : (1) Presenting with typical symptoms of allergic rhinitis, including paroxysmal sneezing, clear rhinorrhea, nasal congestion, and nasal itching, often accompanied by ocular itching, tearing, redness, and a burning sensation. (2) Exhibiting typical signs of allergic rhinitis attacks, including pale and swollen nasal mucosa, swelling of the inferior turbinates, and abundant watery nasal secretions. (3) Positive skin prick test (SPT) results (15-20 minutes, with average wheal diameter greater than 3mm compared to the negative control group). Alternatively, serum evidence demonstrating sensitivity to at least one allergen, with specific IgE levels =0.35 kU/L used as the detection index. 3. Complete medical history available and ability to comprehend and sign a written informed consent form.

Exclusion criteria

Exclusion criteria: 1. Subjects who are pregnant or lactating. 2. Diagnosed with chronic sinusitis or other allergic diseases (such as allergic skin diseases or allergic asthma) or respiratory tract infections within 6 months. 3. Underwent any nasal cavity-related surgery within the past 6 months, such as septoplasty, nasal implantation, or nasal sinus stent insertion. 4. Used antibiotics or antiviral drugs within 1 month prior to enrollment, or used corticosteroid drugs within the past month. 5. Currently undergoing, or received chemotherapy, radiotherapy, biologics, immunosuppressive therapy, allergen immunotherapy, or investigational drug therapy within 3 months prior to the initial intervention. 6. Any subjects considered unlikely to survive during the study period, such as those with severe primary diseases affecting the cardiovascular, liver, kidney, and hematopoietic systems, or subjects with any rapidly progressing or life-threatening diseases (such as cancer). 7. Subjects with other diseases that may affect respiratory function (such as neurological diseases). 8. Subjects with a known history of HIV infection or existing parasitic infections. 9. Investigators, co-investigators, study coordinators, participants, or immediate family members of the above personnel involved in the study or at the study site participating in this research.

Design outcomes

Primary

MeasureTime frame
Total Nasal Symptom Score(TNSS);Occurrence and frequency of Adverse Events (AEs);

Secondary

MeasureTime frame
Visual Analog Scale(VAS);Total Ocular Symptom Score(TOSS);Rhinitis Control Assessment Test(RCAT);Nasal resistance;Cytokine levels of nasal lavage fluid;Blood routine examination;Blood biochemical test;Serum IgE;Nasal microbiota abundance;

Countries

China

Contacts

Public ContactHuanhai Liu/Jin Hou

The Second Affiliated Hospital of Naval Medical University (Changzheng Hospital)

liuhuanhaiok@smmu.edu.cn+86 134 8281 6777

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 27, 2026