Efficacy and safety of Yinaokang capsules on functional recovery after acute ischemic stroke: protocol for a pilot, prospective, randomized, open-label, blinded-endpoint trial.

BACKGROUND: Previous studies suggest that Yinaokang Capsules (YNKC) may offer therapeutic benefits for acute ischemic stroke (AIS) by reducing atherosclerosis, inhibiting inflammatory mediators, and exhibiting neuroprotective properties. Nonetheless, there is currently a lack of substantial clinical data that validates the overall efficacy and safety of YNKC. Furthermore, the systemic metabolic changes that underpin its neurovascular protective effects have not been thoroughly investigated in clinical contexts. METHODS: This study is a prospective, randomized, open-label, blinded-endpoint trial designed to enroll 80 patients diagnosed with AIS aged between 18 and 80 years at the Guangdong Provincial Hospital of Chinese Medicine. Eligible participants must present within 72 h of symptom onset and have a baseline National Institutes of Health Stroke Scale (NIHSS) score ranging from 4 to 22. Participants will be randomly assigned in a 1:1 ratio to either the YNKC group or the control group. Those in the YNKC group will receive four YNKC orally three times daily for a duration of 14 days. All participants will concurrently receive standard guideline-based medical treatment. The primary efficacy outcome will be 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 included the overall distribution of mRS scores, NIHSS score, Montreal Cognitive Assessment (MoCA) scores, Traditional Chinese Medicine (TCM) Syndrome Scores, Barthel Index (BI) score, the Stroke-Specific Quality of Life (SS-QoL) scores. The main safety outcome will be the incidence of adverse events (AEs) and serious adverse events (SAEs). Additionally, targeted blood metabolomics will be conducted to explore the underlying metabolic mechanisms of YNKC. CONCLUSION: Aims to evaluate the impact of YNKC on day 90 functional prognosis of patients with AIS, and to explore its underlying metabolic mechanisms. CLINICAL TRIAL REGISTRATION: itmctr.ccebtcm.org.cn, ITMCTR2025001037.