NCT05890573

Efficacy of Bailing Capsule on Pulmonary Fibrosis After COVID-19

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 242 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Pulmonary fibrosis is a sequela of severe infection COVID-19.The prevalence of PCFP ranged from 2% to 45%,and the pathogenesis of PCFP has not been clearly elucidated.The ingredient of Bailing capsule is Cs-C-Q80,it has obvious protective effect on lung. Studies have shown that Bailing capsule may improve the clinical symptoms of PCPF patients through anti-fibrosis, oxidation and anti-inflammatory effects in multiple pathways. The purpose of this study was to evaluate the efficacy and safety of bailing capsule in treating PCFP after COVID-19 infection.

Detailed description

This is a multicenter, prospective, open, randomized controlled clinical study. Bailing capsule was used for 12 weeks of convalescent treatment in patients with COVID-19 infection to evaluate the efficacy and safety of Bailing capsule on pulmonary fibrosis changes after COVID-19 infection. The study consisted of a 1-week screening period and a 12-week randomized treatment period. Screening period (V0) : All subjects who have signed informed consent will enter a screening period (up to 7 days) to assess eligibility. Subjects with confirmed pulmonary fibrosis changes after COVID-19 infection were required to complete relevant procedures, examinations and assessments according to the study procedure table during the screening period. Randomized treatment period (V1\~V3) : The randomized treatment period included V1 to V3 visits. At baseline visit (V1), eligible subjects will be randomly assigned to 6 capsules of Bailing Capsule, tid group, or blank control group in a 1:1 ratio, and receive appropriate treatment during the treatment period: 1. Experimental group: 6 capsules of Bailing capsule, tid group (n=121), a total of 12 weeks. 2. Control group: blank control (n=121). During randomized treatment, subjects will be required to complete procedures, examinations, and evaluations according to the study protocol.

Conditions

• Pulmonary Fibrosis
• COVID-19 Pneumonia

Interventions

Type	Name	Description
DRUG	Bailing capsule	6 Bailing capsules,po,tid,12 weeks

Timeline

• Start date: 2024-04-16
• Primary completion: 2024-05-31
• Completion: 2024-12-31
• First posted: 2023-06-06
• Last updated: 2024-04-17

Locations

1 site across 1 country: China