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Treatment of allergic rhinitis with Zhiyuanning Baizhi bacteriostatic: Prospective, multicenter, randomized, double-blind placebo parallel controlled clinical trial study

Treatment of allergic rhinitis with Zhiyuanning Baizhi bacteriostatic: Prospective, multicenter, randomized, double-blind placebo parallel controlled clinical trial study

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400091120
Enrollment
Unknown
Registered
2024-10-21
Start date
2024-08-20
Completion date
Unknown
Last updated
2024-10-28

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

Conditions

allergic rhinitis

Interventions

Test group:Zhiyuanning Baizhi bacteriostatic

Sponsors

the First Affiliated Hospital of Xi 'an Jiaotong University Yulin Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1) Age 18-65 years old (including boundary value); 2) No gender limitation; 3) Meet the diagnostic criteria of allergic rhinitis in the Chinese Guidelines for the Diagnosis and Treatment of Allergic rhinitis (Revised Edition 2022) : (1) Symptoms: two or more symptoms, such as paroxysmal sneezing, watery nose, nasal itching and nasal congestion, persist or accumulated for more than 1 hour per day, may be accompanied by eye symptoms such as tearing, eye itching and eye redness; ? Physical examination: bilateral nasal mucosa pale, swollen, lower turbinate edema, nasal cavity with watery secretions; Allergen testing: At least one allergen is positive for SPT and/or clear specific IgE, or positive for nasal stimulation test. 4) Nasal symptom score (TNSS)=8 points during screening; 5) Voluntarily sign informed consent, and agree to participate in all visits, examinations and treatments as required by the experimental protocol.

Exclusion criteria

Exclusion criteria: 1) Allergic to any component of the test drug; 2) Nasal polyps or severe deviated septum; Infectious paranasal sinusitis, otitis media; 3) Those with bronchiectasis, tuberculosis, COPD or other respiratory diseases and those with respiratory infections within 14 days; 4) Patients with serious cardiovascular and hematological diseases, and ALT=2ULN or AST=2ULN or Cr= 1.5ULN; 5) Patients with malignant tumors; 6) Pregnant or lactating women; Or if the subject or his or her partner is unable to use the prescribed contraceptive method within 3 months from the date of signing the informed consent to the last dose. 7) Patients with the following combined drug use before screening: a. Immunotherapy within 180 days; b. Oral or nasal inhalation or intraocular use of corticosteroids within 14 days; c. Eye drops or oral chromones within 14 days; d. Oral antihistamine within 14 days, nasal antihistamine within 10 days, eye drops of antihistamine within 3 days; e. Use anti-leukotriene drugs within 7 days; f. Use vasoconstrictors and anticholinergics within 7 days; 8) Participants in any other clinical trial within 2 months prior to screening; 9) According to the judgment of the investigator, those who are not suitable to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
total nasal symptom scores (TNSS);

Secondary

MeasureTime frame
total ocular symptom scores (TOSS);hinoconjunctivitis quality of life questionnaire (RQLQ);

Countries

China

Contacts

Public ContactWendong Hao

the First Affiliated Hospital of Xi 'an Jiaotong University Yulin Hospital

hwdxjtu2024@126.com+86 187 0011 3089

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026