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A multi-centers, randomized, double blinding, controlled trial for rupatadine fumarate tablet in the treatment of allergic rhinitis

A multi-centers, randomized, double blinding, controlled trial for rupatadine fumarate tablet in the treatment of allergic rhinitis

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-17013841
Enrollment
Unknown
Registered
2017-12-11
Start date
2008-01-01
Completion date
Unknown
Last updated
2017-12-18

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

Conditions

allergic rhinitis

Interventions

experiment group:Rupatadine Fumarate

Sponsors

EYE and ENT Hospital of Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Male and female patients aged 18-65 years old; 2. patients with definite diagnosis of allergic rhinitis (the diagnostic criteria are detailed in the appendix); 3. nasal symptoms and signs of the total score more than 8 points; 4. agree to participate in this study and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. non allergic rhinitis (including vasomotor rhinitis, allergic eosinophilic rhinitis, acute rhinitis, chronic rhinitis, atrophic rhinitis, rhinitis etc.), allergic rhinitis and asthma, allergic rhinitis and headache, anatomy and other factors caused by nasal congestion (including severe nasal septum, nasal polyps and nasal inflammation); 2. complicated with ENT diseases and respiratory system (including bronchial asthma, secretory otitis media, etc.), upper respiratory tract infection, and the author with asthma; 3. with postural hypotension and organic heart disease; electrocardiogram found a clinical significance change; 4. patients with thyroid disease, diabetes, hypoglycemia, cardiovascular disease, prostatic hypertrophy, glaucoma and hypertension, scar history, liver function (ALT, AST), renal function (BUN, Cr) 1.5 times higher than the normal value, hematopoietic dysfunction, intestinal diseases, gastric malignant tumor and other serious effects may affect the correct assessment a variety of useful disease history; 5. patients had a history of mental and neuropathy; 6. before the trial, the patients received the following treatment: Immunotherapy within 12 months; Long effect glucocorticoid injection within 3 months; Asimazole in 6 weeks; Systemic or local (inhalation or nasal spray) with glucocorticoid within 1 months; Sodium glycolate or naolometholomethene sodium in 1 months; Long-lasting antihistamine within 1 months; Short effective antihistamine drugs within 1 weeks; 2 weeks of ketotefene, tricyclic antidepressants, macrolide antibiotics and antifungal agents; Systemic or local nasal hyperemia in 24h; Antihistamine active drugs; anticholinergic drugs and antiarrhythmic drugs; Barbiturate, antispasmodic, phentolamine and digitalis; 7. those who are allergic to histamine are known or suspected to be allergic to the research drugs (or similar compounds) or their components; 8. patients who participated in other clinical trials in the last three months; 9. pregnant or lactating women and persons or drivers engaged in dangerous operations; 10. patients with a recent birth plan; 11. poor compliance; 12. researchers think there are any unsuitable candidates.

Design outcomes

Primary

MeasureTime frame
Effecacy and safety;

Countries

China

Contacts

Public ContactDehui Wang

EYE and ENT Hospital of Fudan University

wangdehuient@sina.com+86 021-64377134-2202

Outcome results

None listed

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