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A randomized, double-blind, placebo-controlled, multicenter clinical trial of Hemocoagulase Atrox for Injection for endoscopic sinus surgery in the treatment of chronic sinusitis and nasal polyps

A randomized, double-blind, placebo-controlled, multicenter clinical trial of Hemocoagulase Atrox for Injection for endoscopic sinus surgery in the treatment of chronic sinusitis and nasal polyps

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IIR-17013833
Enrollment
Unknown
Registered
2017-12-11
Start date
2009-07-01
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

Chronic sinusitis

Interventions

experimental group:Lizhixue
Control :placebo

Sponsors

EENT Hospital of Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with chronic rhinosinusitis and polyps with multiple Lund-Mackay scores based on CT examination need endoscopic sinus surgery; 2. aged 18-65 years; 3. The researchers have decided that there is no surgical contraindication and no coagulant system disease; 4. Pre operation platelets were normal, PT and APTT were within the normal range of the hospital; 5. The informed consent and the signing of the informed consent.

Exclusion criteria

Exclusion criteria: 1. unilateral (simple left or right) chronic rhinosinusitis and nasal polyps; 2. Those who are known to be allergic to any of the ingredients in this product; 3. A drug (such as EDTA) is being used in the use of a substance containing a calcium binding component; 4. Patients who have used blood clotting drugs 2 weeks before operation; 5. Clinical trials of other research drugs in the near four weeks; 6. Patients with a history of thrombus history or hypercoagulable state; 7. Patients with bleeding tendency or severe blood system disease; 8. systemic diseases such as severe hypertension, tuberculosis, diabetes and liver disease are not controlled, and the researchers believe that they may interfere with diseases such as research or evaluation; 9. abnormal liver function AST, ALT multiple hospital normal range upper limit 1.5 times kidney function abnormal blood creatinine multiple normal upper limit 1.2 times; 10. pregnancy or planned half a year of pregnancy planners and lactation women; 11. Other researchers think it is not suitable for the entry of the group.

Design outcomes

Primary

MeasureTime frame
Intraoperative bleeding;Operation time;

Countries

China

Contacts

Public ContactWang Dehui

EENT 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