Study of Tetrandrine Tablets for Adults With Connective Tissue Disease-Related Interstitial Lung Disease Randomized, Double-Blind, Placebo-Controlled Trial Assessing Lung Function and Safety Over 24 Weeks

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.

A Study to Test Tetrandrine Tablets for Connective Tissue Disease-Related Lung Disease