Supplementary file 2_Efficacy and safety of Songjiao Dihuang Tang decoction for the dynami

A 28-day treatment protocol for a prospective, multicentre, randomized controlled trial involving 200 patients with mild immune checkpoint inhibitor-associated myocarditis. The study, authored by Jingyi Long and registered in July 2025, aims to assess the efficacy and safety of Songjiao Dihuang Tang decoction combined with conventional corticosteroid therapy. The protocol includes a 'stop&go' adaptive design with assessments at 24–72 hours, day 14, and day 28, followed by follow-ups at months 1, 3, and 5.

Use Cases

• Analyzing adaptive trial design strategies based on the 'stop&go' protocol described for managing rapid disease progression.
• Modeling cardiac biomarker (cTn) recovery time as a primary outcome measure for treatment efficacy.
• Studying the integration of Traditional Chinese Medicine (TCM) with conventional steroid therapy for managing immunotherapy side effects.

Strengths

• The protocol is detailed, specifying a sample size of 200 patients and a 1:1 randomization ratio.
• It follows a predefined statistical analysis plan, including methods for handling missing data and evaluating primary, secondary, and safety outcomes.
• The study design is multicentre and double-blind, which likely reduces centre-specific bias.

Limitations

• The dataset is a 146.6 KB PDF protocol document; the actual clinical trial results data are not included.
• Column-level documentation for any resulting data is absent; field semantics must be inferred from the protocol after download.
• Row count for any eventual clinical data is unknown, which may limit suitability assessment.

Provenance

Source

figshare

Collection Method

Published clinical trial study protocol and statistical analysis plan.

Time Range

The trial protocol was registered retrospectively on 16 July 2025.

Freshness

Last updated 2026-05-12 05:26:49; freshness should be verified.

Geography

Likely China, based on the reference to 2020 Chinese Expert Consensus criteria and the Chinese clinical trial registry.