Supplementary file 4_Efficacy and safety of Songjiao Dihuang Tang decoction for the dynami

A Chinese multicentre clinical trial protocol for a randomized, double-blind study investigating a Traditional Chinese Medicine decoction. The study, authored by Jingyi Long and published on figshare in 2026, aims to enroll 200 patients with mild immune checkpoint inhibitor-associated myocarditis. It details a 'stop&go' adaptive design with assessments over a 6-month follow-up period.

Use Cases

• Analyzing adaptive clinical trial designs based on the described 'stop&go' methodology with biomarker-triggered decisions.
• Studying composite clinical endpoints in cardiology based on the listed primary (cTn recovery time, treatment efficacy rate) and secondary outcomes (ICIAM progression rate, MACE).
• Investigating integrative oncology treatment protocols based on the combination of Songjiao Dihuang Tang with conventional corticosteroid therapy.

Strengths

• The protocol is detailed, specifying a sample size of 200 patients and a 6-month follow-up schedule.
• It follows a structured, predefined statistical analysis plan including methods for missing data imputation.

Limitations

• The dataset is a 202.9 KB PDF protocol document, not a structured data file containing trial results or patient records.
• Column-level documentation for any resulting data is absent; field semantics must be inferred from the protocol text.

Provenance

Source

figshare, author Jingyi Long.

Collection Method

Described as a prospective, multicentre randomized controlled trial.

Freshness

Last updated 2026-05-12 05:26:50.

Geography

Implies a Chinese clinical context, based on the referenced 2020 Chinese Expert Consensus criteria.