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A randomized controlled trial for the efficacy of fudosteine in chronic sinusitis

A randomized controlled trial for the efficacy of fudosteine in chronic sinusitis

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900022466
Enrollment
Unknown
Registered
2019-04-12
Start date
2019-04-26
Completion date
Unknown
Last updated
2019-04-15

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

Conditions

Chronic sinusitis

Interventions

Observation group:Fudosteine 400mg, tid, continuous treatment for 14 days
Control group:Placebo 400mg, tid, 14d

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Comply with CRS diagnostic criteria; (2) Aged 18 to 70 years, and the VAS score and/or the post-nasal drip VAS score of the chronic sinusitis is greater than 5 points; (3) The main clinical manifestations are nasal congestion, olfactory loss, rhinorrhea, head suffocation or pressure. Nasal endoscopy mainly manifests as hypertrophy of the inferior turbinate and/or middle turbinate, purulent secretion in the posterior nostril, nasopharynx or in the lower nasal passage, middle nasal passage, and no atrophic rhinitis.

Exclusion criteria

Exclusion criteria: (1) Patients with obvious anatomical abnormalities in the sinus and nasal passage complex; (2) An acute upper respiratory tract infection or an acute CRS author before treatment; (3) Patients with serious systemic diseases such as cancer; (4) Those who are allergic to this product; (5) Liver and kidney dysfunction and heart disease, blood disease patients; (6) Those who are unable to cooperate with mental illness or other reasons; (7) Women during pregnancy and lactation.

Design outcomes

Primary

MeasureTime frame
Nasal secretion traits before and after treatment;VAS score;SNOT-20;LK endoscopy score;Clinical efficacy;

Secondary

MeasureTime frame
IL-1?IL-4?IL-8?IFN-??TNF;MUC5AC?MUC5B;

Countries

China

Contacts

Public ContactLiu Feng
alexliufeng@vip.163.com+86 18628979607

Outcome results

None listed

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