This paper presents a protocol for a pilot, prospective, randomized, open-label, blinded-endpoint trial designed to evaluate the efficacy and safety of Yinaokang Capsules (YNKC) on functional recovery after acute ischemic stroke, with a primary outcome of favorable functional outcome (mRS 0-1) at day 90.
The trial is designed to enroll 80 patients with acute ischemic stroke at Guangdong Provincial Hospital of Chinese Medicine.
The YNKC treatment regimen consists of four capsules taken orally three times daily for 14 days, administered alongside standard guideline-based medical treatment.
The primary efficacy outcome is the proportion of patients achieving a favorable functional outcome defined as a modified Rankin Scale (mRS) score of 0 to 1 at day 90 following randomization.
Secondary outcomes include multiple validated clinical scales assessing neurological function, cognition, traditional Chinese medicine syndromes, functional independence, and quality of life.
Safety outcomes include the incidence of adverse events (AEs) and serious adverse events (SAEs).
The trial incorporates targeted blood metabolomics to explore the underlying metabolic mechanisms of YNKC.
Prior preclinical and preliminary evidence suggests YNKC may offer therapeutic benefits for acute ischemic stroke through multiple mechanisms.
This paper describes the design and protocol for a clinical trial testing whether a traditional Chinese medicine product called Yinaokang Capsules (YNKC) can help patients recover better after an acute ischemic stroke (a stroke caused by a blood clot). The trial will enroll 80 stroke patients at a hospital in China, randomly assigning them to receive either YNKC plus standard stroke care, or standard stroke care alone. Patients take four YNKC capsules three times a day for two weeks, and their recovery is tracked over 90 days using several validated measures of disability, neurological function, thinking ability, and quality of life. The main question is whether more YNKC-treated patients achieve near-complete recovery (minimal or no disability) by 90 days. This research suggests that while laboratory and early studies have indicated YNKC might reduce brain-damaging inflammation and protect blood vessels in the brain, solid clinical evidence for its effectiveness and safety in human stroke patients is still lacking. The trial is designed as a pilot study, meaning it is intended to gather preliminary data and assess feasibility before a larger, more definitive trial could be conducted. Alongside clinical outcomes, the researchers will analyze blood samples using metabolomics — a technique that measures many chemical compounds at once — to try to understand how YNKC might be affecting the body's metabolism in ways that protect the brain. This study matters because stroke is a leading cause of disability worldwide, and current treatment options are limited, particularly for patients who cannot receive clot-busting drugs or surgery. If YNKC proves to be safe and effective, it could represent an additional treatment option, especially in settings where traditional Chinese medicine is part of routine care. The metabolomics component could also help scientists understand the biological pathways involved, which might point toward new therapeutic targets for stroke recovery more broadly.
Li Y, Qiu Y, Wang H, Zheng M, Liu L, Zhang S, et al.. (2026). Efficacy and safety of Yinaokang capsules on functional recovery after acute ischemic stroke: protocol for a pilot, prospective, randomized, open-label, blinded-endpoint trial.. Frontiers in neurology. https://doi.org/10.3389/fneur.2026.1888277