Yiqi-Yangyin-Huoxue Granules Trial Protocol for Type 2 Diabetes and Vascular Aging

A randomized, double-blind, placebo-controlled trial protocol for a 12-week intervention evaluating a natural herbal formulation in 120 participants with type 2 diabetes and early vascular aging. The protocol, authored by Jinyi Fu, describes primary and secondary clinical outcomes, safety evaluations, and planned multi-omics analyses of serum and fecal samples. Recruitment began in March 2025 and is expected to conclude in December 2026.

Use Cases

• Analyzing the effect of herbal formulations on vascular stiffness based on brachial-ankle pulse wave velocity (baPWV) as a primary outcome.
• Evaluating changes in metabolic profiles based on blood glucose levels and lipid profiles mentioned as secondary outcomes.
• Investigating gut microbiome changes in diabetic patients based on metagenomic sequencing of fecal samples.
• Assessing safety profiles of complementary therapies based on liver transaminases and serum creatinine monitoring.

Strengths

• The protocol describes a randomized, double-blind, placebo-controlled design, which is a gold standard for clinical trials.
• It plans to collect multi-omics data, including metabolomic, proteomic, and metagenomic sequencing from serum and fecal samples.
• The trial is registered with an international clinical trial registry (ITMCTR2024000388), providing a public record.

Limitations

• The dataset is a 20.5 KB DOCX file containing only the trial protocol, not the resulting clinical or omics data.
• Column-level documentation for any potential data exports is absent; field semantics must be inferred from the protocol.
• The data described is from a single-center trial, which may limit generalizability.

Provenance

Source

figshare

Collection Method

Clinical trial protocol document.

Time Range

Trial recruitment from March 2025 to December 2026.

Freshness

Last updated 2026-06-03 12:08:48