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Randomized, open-label, parallel controlled clinical trials of Spleen Aminopeptides Oral Solutions in combination with conventional therapy for the treatment of chronic sinusitis with nasal polyps

Randomized, open-label, parallel controlled clinical trials of Spleen Aminopeptides Oral Solutions in combination with conventional therapy for the treatment of chronic sinusitis with nasal polyps

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200059420
Enrollment
Unknown
Registered
2022-04-29
Start date
2022-04-21
Completion date
Unknown
Last updated
2024-03-04

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

Conditions

Allergic rhinitis with chronic sinusitis and nasal polyps

Interventions

Control group:Anti-infection therapy was given for 3 days after CRS. Mometasone furoate nasal spray for 3 months
at the same time, the nasal cavity was irrigated with sea salt water, and mucous stimulating agent was taken orally for 4 weeks.
Experimental group:After CRS, in addition to the above drug therapy, combined with oral splenic aminopeptide solution, medication was given for 3 months.

Sponsors

Beijing Tongren Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. CRSwNP meets the diagnostic criteria of the Chinese guidelines for the diagnosis and treatment of chronic sinusitis (2018); 2. Patients with allergic rhinitis, the diagnosis of allergic rhinitis meets the diagnostic criteria of "Guidelines for the Diagnosis and Treatment of Allergic Rhinitis" (2015); 3. Age 18-65 years old, male or female; 4. Patients undergoing nasal endoscopic surgery; 5. Sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with benign and malignant tumors of the nasal cavity and sinuses; 2. Patients with a history of nasal endoscopic surgery; 3. Patients have been treated with oral/nasal glucocorticoids and oral/nasal antihistamines within 4 weeks before enrollment; 4. Those with obvious liver, heart, kidney, respiratory system, blood system, nervous system, and metabolic diseases in the past or at present; 5. Patients with psychological barriers and mental illnesses that the researchers judged could not be included in the group.

Design outcomes

Primary

MeasureTime frame
Total clinical response rate;

Secondary

MeasureTime frame
Nasal sinus outcome test -22 score;Sinus CT scan with Lund-Mackay score;Nasal endoscopy Lund-Kennedy score;Peripheral blood/nasal secretions EOS;Cytokines in peripheral blood/nasal secretions;Recurrence rate;Symptom score;

Countries

China

Contacts

Public ContactWang Xiangdong

Beijing First Biochemical Pharmaceutical Co., Ltd.

entwxd@vip.sina.com+86 13911189954

Outcome results

None listed

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