SJDHT Clinical Trial Protocol for Immune Checkpoint Inhibitor-Associated Myocarditis

200 patients with mild immune checkpoint inhibitor-associated myocarditis (ICIAM) will be recruited for a randomized controlled trial. The study protocol details a 28-day treatment period with Songjiao Dihuang Tang decoction versus placebo, with follow-ups extending to 6 months. Author Jingyi Long published the protocol on figshare under a CC-BY-4.0 license in May 2026.

Use Cases

• Analyzing treatment efficacy based on cardiac troponin recovery time and treatment efficacy rate.
• Studying disease progression rates based on the 'stop&go' adaptive design and multi-disciplinary team-guided steroid tapering.
• Evaluating safety outcomes based on recorded adverse events and cardiac function indices.
• Comparing Traditional Chinese Medicine efficacy metrics against standard corticosteroid therapy.

Strengths

• Protocol specifies a sample size of 200 patients for the randomized controlled trial.
• Describes a detailed 28-day treatment and 6-month follow-up schedule with specific assessment timepoints.
• Includes a predefined statistical analysis plan covering missing data imputation and primary/secondary/safety outcomes.

Limitations

• The dataset is a 151.2 KB PDF protocol document; the underlying clinical trial data is not included.
• Column-level documentation for the eventual trial results is absent; field semantics must be inferred after download.
• Freshness should be verified; the protocol was last updated in 2026, but the trial data collection period is not specified.

Provenance

Source

figshare

Collection Method

Clinical trial study protocol and statistical analysis plan.

Freshness

Last updated 2026-05-12 05:26:51

Geography

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