Actively Recruiting
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)
Led by Huilan Zhang · Updated on 2024-11-05
124
Participants Needed
1
Research Sites
135 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 80 years
- Diagnosis of connective tissue disease (CTD) such as SLE, SS, SSc, RA, PM/DM according to international criteria
- Diagnosis of interstitial lung disease (ILD) with symptoms, lung function tests, and chest high-resolution CT showing typical changes
- ILD confirmed by chest CT or lung biopsy without other known causes, with specific clinical, serological, or morphological features supporting CTD
You will not qualify if you...
- AST or ALT levels greater than 1.5 times the upper limit of normal
- Bilirubin levels greater than 1.5 times the upper limit of normal
- Creatinine clearance less than 30 mL/min
- Chronic liver disease (Child Pugh A, B, or C)
- Use of other investigational drugs within 1 month or 6 half-lives before screening
- Significant pulmonary arterial hypertension or right heart failure
- Other significant lung abnormalities or major chest physical limitations
- Cardiovascular diseases such as severe hypertension, recent heart attack, or unstable angina within 6 months
- History of severe central nervous system events
- Known allergy to the study drug
- Other medical conditions interfering with study participation
- Women who are pregnant, breastfeeding, or planning pregnancy
- Inability to understand or follow study procedures or complete questionnaires without help
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Tongji hospital affiliated to huazhong university of science and technology
Wuhan, Hubei, China, 430030
Actively Recruiting
Research Team
Z
Zhang Huilan, PD
CONTACT
Y
Yang Luqin, Master
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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