Actively Recruiting
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tetrandrine Tablets in Treating Connective Tissue Disease-Related Interstitial Lung Disease
Led by Peking University Third Hospital · Updated on 2026-01-06
100
Participants Needed
1
Research Sites
11 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of tetrandrine tablets in adults with interstitial lung disease related to connective tissue disease. This phase 4, multicenter, randomized, double-blind, placebo-controlled study involves 100 participants to compare tetrandrine tablets with placebo alongside standard treatments such as glucocorticoids and immunosuppressants. The goal is to understand how tetrandrine affects lung function and inflammation over 24 weeks. Participants are randomly assigned to receive either tetrandrine tablets (60 mg, three times daily) or placebo tablets that mimic tetrandrine, both taken orally for 24 weeks. All participants continue their standard treatment during the study. The treatment period includes visits at weeks 4, 8, 12, and 24 to monitor progress and safety. The study measures several lung function parameters, inflammatory markers, lung imaging scores, quality of life, and records any adverse events. During the trial, participants undergo lung function tests, blood tests to measure inflammatory markers, and high-resolution CT scans of the lungs. Quality of life is assessed using a respiratory questionnaire. Safety is monitored through adverse event reporting and electrocardiogram evaluations. The primary outcome is the change in forced vital capacity after 24 weeks. Participants are involved for at least 24 weeks, with regular visits for assessments and safety monitoring throughout the study.
CONDITIONS
Brief Title
A Study to Test Tetrandrine Tablets for Connective Tissue Disease-Related Lung Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who voluntarily participate and sign the informed consent form
- Male or female patients aged 18-80 years (inclusive)
- Patients meeting the diagnostic criteria for connective tissue disease-related interstitial lung disease per the 2018 Chinese Expert Consensus at screening
- Forced vital capacity (FVC) 6% of predicted value at screening
- Fertile male or female patients must agree to use effective contraception from signing informed consent until 3 months after the last study drug dose (Exemptions: postmenopausal women >50 years with amenorrhea for >1 year, or surgically sterilized women)
- Patients on stable doses of prednisone (620 mg/day or equivalent) or immunosuppressants for at least 4 weeks prior to study entry, with dose adjustments not exceeding this during the double-blind period
You will not qualify if you...
- Treatment with tetrandrine or other antifibrotic drugs within 1 month before screening
- Diabetes with fasting blood glucose greater than 11.1 mmol per L
- Resting arterial oxygen partial pressure less than 50 mmHg
- Active peptic ulcers or bleeding disorders
- Tumors with expected survival less than 1 year
- Active pulmonary tuberculosis
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 5 times the upper limit of normal (ULN) or higher, or ALT or AST 3 times ULN or higher with total bilirubin 2 times ULN or higher
- Creatinine clearance less than 30 mL per min (per Cockcroft-Gault formula) or patients receiving dialysis
- Known allergy to tetrandrine or its excipients
- Severe psychological, mental, cognitive, or intellectual impairments that may affect compliance
- Pregnant or breastfeeding women, or those planning pregnancy within 3 months after the last study drug dose
- Participation in another clinical trial within 3 months before screening
- Patients deemed unsuitable for the study by the investigator
- Clinically significant environmental exposure history that may cause pulmonary fibrosis (e.g., amiodarone, asbestos, beryllium, radiation)
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks
Participants are randomized to receive either tetrandrine tablets or placebo tablets, taken three times daily for 24 weeks alongside standard treatment with glucocorticoids and immunosuppressants.
Visits at weeks 4, 8, 12, and 24 for efficacy and safety assessments
Trial Site Locations
Total: 1 location
1
Peking University Third Hospital
Beijing, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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