Supplementary file 5_Efficacy and safety of Songjiao Dihuang Tang decoction for the dynami

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, detail a 28-day treatment period with follow-ups extending to 6 months. The document was last updated on 12 May 2026.

Use Cases

• Analyzing treatment efficacy based on cardiac troponin (cTn) recovery time and treatment efficacy rate.
• Modeling disease progression risk based on weekly cTn monitoring and Major Adverse Cardiac Events (MACE).
• Evaluating steroid tapering protocols in conjunction with Traditional Chinese Medicine decoction.
• Assessing patient quality of life and cancer-related symptom changes over a 6-month follow-up period.

Strengths

• The protocol is detailed, specifying a sample size of 200 patients and a 6-month follow-up schedule.
• It employs a 'stop&go' adaptive design with specific assessment timepoints (24-72h, day 14, day 28).
• Primary and secondary outcomes are clearly defined, including cardiac function indices and TCM efficacy.

Limitations

• The dataset is a 173.0 KB PDF protocol document; the underlying clinical trial data is not provided.
• Column-level documentation for the actual trial results is absent; field semantics must be inferred from the protocol.
• Row count for the eventual clinical data is unknown, which may limit suitability assessment.

Provenance

Source

figshare

Collection Method

Prospective, multicentre, randomized, parallel-controlled, double-blind clinical trial protocol.

Time Range

The trial includes a 28-day treatment period and a total follow-up of 6 months.

Freshness

Last updated 2026-05-12 05:26:50; freshness should be verified.

Geography

Multicentre trial; specific geographic locations are not stated.