NCT06674148

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of the Efficacy and Safety of Qifangfeixian Granules in the Treatment of Connective Tissue Disease-Associated Interstitial Lung Disease (CTD-ILD)

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 124 (estimated)
• Sponsor: Huilan Zhang · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Interstitial lung disease (ILD) is a heterogeneous group of diseases characterized by inflammation and/or fibrinization of the alveolar unit due to a variety of known or unknown causes. CTD-ILD is one of its common categories and includes any ILD with a definite diagnosis of connective tissue disease or with a set of symptoms, signs, and abnormalities suggested by laboratory examination. The incidence of CTD-ILD varies from home to abroad. Foreign studies indicate that the number of CTD-ILD in this study accounted for 34.8% of the total number of ILD in this study, while domestic studies indicate that the number of CTD-ILD in this study accounted for 67% of the total number of ILD. At present, the treatment of CTD-ILD includes hormone, immunosuppressant cyclophosphamide, mortemycophenate, tacrolimus, etc. The above treatment has great side effects, which may increase the risk of infection and the incidence of malignant tumor. Traditional Chinese medicine has unique advantages in alleviating the clinical symptoms of the disease, reducing the use of hormones and hormone complications, and preventing infection. Qifangfeixian granule is derived from "Fangji Huangqi Decoction" in the Summary of Golden Chamber. Modern pharmacology shows that Huangqi has the functions of regulating immunity, protecting liver, antibacterial and antiviral, etc. In order to further evaluate the effectiveness and safety of using Qifangfeixian granule (Huangqi, Fangji, dogwood, dodder, ginkgo, salvia miltiorrhizae, Taoren, etc.) in the treatment of CTD-ILD patients, Determined to explore a path of CTD-ILD treatment with Chinese characteristics, we hereby apply for a multicenter controlled clinical study.

Detailed description

ILD is a common complication of CTD, with high disability rate and fatality rate, poor prognosis and high fatality rate. Ild is one of the main causes threatening the life of patients. The objective of this study was to evaluate the efficacy and safety of Qifangfeixian granules in the treatment of CTD-ILD patients, and to provide a new treatment plan for CTD-ILD patients. This is a randomized, placebo-controlled, multicenter study to evaluate the efficacy and safety of Qifangfeixian granules in the treatment of patients with fibrotic interstitial lung disease. The study drugs included Qifangfeixian Granule and placebo, which was identical in appearance, taste and weight with Qifangfeixian Granule, and were given 1 bag twice a day. This study planned to enroll 124 subjects, who were randomly assigned at a ratio of 1:1, with 62 subjects in each group. Subjects who met all the inclusion criteria and did not meet the exclusion criteria at baseline were randomly assigned to either of the following two groups: (1) Qifangfeixian Granule treatment group: orally administered with 1 bag of Qifangfeixian granule twice a day; (2) Placebo (PRO) control group: orally administered with 1 bag of placebo twice a day. If participants withdraw from the study early, they will be followed up for 4 weeks. Participants were allowed to make dose adjustments during treatment and were withdrawn from the study when a serious adverse event occurred or medication was discontinued due to an adverse event. Throughout the course of the study, safety checks and assessments will be conducted according to the time points specified in the protocol, including adverse events, HRCT, clinical laboratory tests (blood routine, blood biochemistry, urine routine, coagulation function, myocardial enzymes, etc.), 12-lead electrocardiogram, vital signs, and physical examination. Patient data were recorded on the case report form based on the visit.

Conditions

• Interstitial Lung Disease
• Qifangfeixian Granules

Interventions

Type	Name	Description
DRUG	Qifangfeixian granules	The experimental group was treated with Qifangfixian granules
OTHER	Placebo	The control group was treated with placebo

Timeline

• Start date: 2024-10-25
• Primary completion: 2027-05-20
• Completion: 2027-06-01
• First posted: 2024-11-05
• Last updated: 2024-11-05

Locations

1 site across 1 country: China