Clinical Efficacy of Xiaoqinglong Decoction in Treatment of Eosinophilic Nasal Polyp and Mechanism of Reducing Th2 Inflammatory Factors

Phase 2

Recruiting

• Conditions: Chronic sinusitis with nasal polyps

• Registration Number: ITMCTR2100005008
• Lead Sponsor: The First Affiliated Hospital of Guangzhou University of Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Subjects must voluntarily participate in this study and abide by the study regulations, understand and abide by the medication dosage, follow up plan, correctly record adverse event records, and voluntarily sign the written informed consent;
2. Aged 18 to 70 years old male and female;
3. Diagnostic criteria are based on the CRS diagnostic criteria for nasal polyps associated with European Guidelines for the Diagnosis and Treatment of Rhinosinusitis and Nasal Polyps 2020. This included subjective evaluation, endoscopy and imaging examination of patients;
4. Patients with VAS score 3 to 7 and polyps >=1 in Lund-Kennedy score of nasal endoscopy;
5. The mucosal tissues of nasal polyps were stained with HE. At high magnification, eosinophils >=10% of total inflammatory cells.

Exclusion Criteria

1. Pregnant or lactating women;
2. Subjects had cystic fibrosis, congenital ciliary dyspraxia, non-invasive fungal balls and invasive mycosis, systemic vasculitis and granulomatous disease, tumor patients, immunodeficiency, and allergic fungal sinusitis;
3. The subject is allergic to hormones;
4. Subjects with other autoimmune diseases are receiving long-term immunosuppressive drug therapy;
5. Subjects are suffering from respiratory tract infection;
6. Clinically serious metabolic, cardiovascular, immune, neurological, hematological, digestive, cerebrovascular, or respiratory diseases, or any disease considered by the Investigator to interfere with the evaluation of study results or affect the safety of subjects;
7. Currently participating in other clinical studies or participating in other clinical investigators within 30 days, or directly participating in the study staff;
8. Having a history of mental illness, antagonistic personality, bad motivation, paranoia or other emotional or intellectual problems may affect the informed effectiveness of study participants;
9. Other CRS drugs or other treatments, such as nasal irrigation, were administered topically and systemically during the first 4 weeks of the trial.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
IL-13;IL-5;IL-4;