Tanshinone IIA Activates Nuclear Factor-Erythroid 2-Related Factor 2 to Restrain Pulmonary Fibrosis via Regulation of Redox Homeostasis and Glutaminolysis.
Lin An, Li-Ying Peng, Ning-Yuan Sun...
https://pubmed.ncbi.nlm.nih.gov/30105924Actively Recruiting
Phase 2
Phase 3
Age: 18Years - 80Years
All Genders
ID06674148
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
Led by Huilan Zhang · Updated on 2024-11-05
124
Participants Needed
1
Research Sites
1 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Interstitial lung disease (ILD) is a group of diseases involving inflammation or scarring in the lungs, with connective tissue disease-associated ILD (CTD-ILD) being a common form. CTD-ILD can occur with a known diagnosis of connective tissue disease or with related symptoms and lab findings. Treatments currently include hormones and immunosuppressants, which may cause serious side effects like infection and increased cancer risk. This research aims to evaluate the effectiveness and safety of Qifangfeixian granules, a traditional Chinese medicine, as a potential treatment for CTD-ILD. This randomized, placebo-controlled, multicenter study will compare Qifangfeixian granules to a placebo in patients with fibrotic CTD-ILD. Participants will be randomly assigned to receive either 1 bag of Qifangfeixian granules or a placebo twice daily. The study plans to enroll 124 subjects divided equally between the treatment and placebo groups. Dose adjustments may be made during treatment, and participants will be followed for 4 weeks if they withdraw early. The study will monitor for adverse events and medication safety throughout. Participants will attend visits for safety assessments including imaging with high-resolution CT scans, blood and urine tests, electrocardiograms, vital signs, and physical exams. Clinical data and patient questionnaires will be collected at specific time points. The primary outcome is lung function measured by forced vital capacity over 12 weeks. Secondary outcomes include hormone dosage changes and symptom scores related to pulmonary fibrosis. The study duration and follow-up details are planned according to the protocol to assess both effectiveness and safety.
CONDITIONS
Brief 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
Age: 18Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 80 years
- Diagnosis of connective tissue disease according to international classification standards (e.g., SLE, SS, SSc, RA, PM/DM)
- Diagnosis of interstitial lung disease confirmed by symptoms, pulmonary signs, lung function tests, and high-resolution chest CT
- Alternatively, confirmed ILD by chest CT or lung biopsy without other known causes and at least 2 clinical, serological, or morphological features related to CTD
You will not qualify if you...
- Liver enzyme levels (AST, ALT) greater than 1.5 times the upper normal limit at screening
- Bilirubin levels greater than 1.5 times the upper normal limit at screening
- Creatinine clearance less than 30 mL/min at screening
- Underlying chronic liver disease (Child Pugh A, B, or C)
- Use of other investigational drugs within 1 month or 6 half-lives prior to screening
- Significant pulmonary arterial hypertension or right heart failure
- Other clinically significant lung abnormalities
- Major physical limitations affecting lungs (e.g., chest wall malformations, massive pleural effusion)
- Severe cardiovascular diseases including uncontrolled hypertension, recent myocardial infarction, or unstable angina within 6 months
- History of severe central nervous system events
- Known allergy to the study drug
- Medical conditions interfering with trial participation or putting patient at risk
- Pregnant, breastfeeding, or planning pregnancy
- Unable to understand or follow trial procedures independently
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 12 weeks
Participants receive either Qifangfeixian granules or placebo orally twice a day. Safety checks and assessments including HRCT, clinical laboratory tests, electrocardiogram, vital signs, and physical examination are conducted throughout treatment.
Multiple visits during treatment as per protocol for safety and assessments
Follow-up
Duration - 4 weeks
Participants who withdraw early from the study are followed up for safety and assessments for 4 weeks.
1 to 2 visits during follow-up
Trial Site Locations
Total: 1 location
1
Tongji hospital affiliated to huazhong university of science and technology
Wuhan, Hubei, China, 430030
Actively Recruiting
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Research Team
Z
Zhang Huilan, PD
Y
Yang Luqin, Master
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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