Songjiao Dihuang Tang Clinical Trial Protocol for Immune Checkpoint Inhibitor Myocarditis

200 patients with mild immune checkpoint inhibitor-associated myocarditis (ICIAM) will be enrolled in a randomized controlled trial. The study protocol and statistical analysis plan, authored by Jingyi Long and published on figshare under CC-BY-4.0 on 2026-05-12, details a 'stop&go' adaptive design to evaluate the efficacy and safety of Songjiao Dihuang Tang decoction combined with conventional corticosteroid treatment. The primary outcomes are cardiac troponin (cTn) recovery time and treatment efficacy rate.

Use Cases

• Analyzing adaptive trial design methodologies based on the described 'stop&go' protocol with weekly biomarker monitoring.
• Studying cardiac biomarker (cTn, myocardial enzymes) trajectories in immunotherapy patients based on the described longitudinal assessments.
• Evaluating composite clinical endpoints (MACE, progression rate, quality of life) for immune-related myocarditis based on the listed secondary outcomes.
• Benchmarking statistical analysis plans for Traditional Chinese Medicine clinical trials based on the described imputation and outcome evaluation methods.

Strengths

• The protocol is detailed, specifying a sample size of 200 patients and a 6-month follow-up period with assessments at multiple time points.
• It follows a predefined statistical analysis plan and is registered with a clinical trial registry (ITMCTR2025001424).
• The study design is explicitly described as a prospective, multicentre, randomized, parallel-controlled, double-blind superiority trial.

Limitations

• The dataset is a 610.5 KB PDF protocol document; the underlying patient-level clinical trial data is not included.
• Column-level documentation for the eventual trial results is absent; field semantics must be inferred from the protocol.
• The data reflects the specific patient population and treatment regimen defined by the trial, which may limit generalizability.

Provenance

Source

figshare

Collection Method

Clinical trial study protocol and statistical analysis plan.

Freshness

Last updated 2026-05-12 05:26:49.

Geography

Multicentre trial, likely conducted in China based on referenced Chinese Expert Consensus criteria.