Qizhi Jieyu Pill for the Treatment of Cerebral Infarction During the Recovery Phase: Protocol for a Randomized Controlled Clinical Trial (Preprint)

BACKGROUND Cerebral infarction, a life-threatening neurodegenerative disease, is one of the leading causes of disability and death. The recovery phase is a critical period for patients to regain cognitive ability, memory, and motor functions and to improve their ability to perform daily activities. Over the past 10 years, we have applied Qizhi Jieyu pill in the treatment of patients in the recovery phase of cerebral infarction. We retrospectively analyzed clinical data from 152 patients and found preliminary results suggesting that Qizhi Jieyu pill may help alleviate clinical symptoms, improve quality of life, and reduce the recurrence of cerebral infarction. However, the lack of high-quality clinical evidence supporting its efficacy and safety has limited its widespread clinical application. OBJECTIVE This protocol describes a randomized controlled trial aiming to evaluate the efficacy and safety of Qizhi Jieyu pill in patients during the recovery phase of cerebral infarction. METHODS This study adopts a multicenter, randomized controlled clinical trial design. A total of 126 patients aged 30-70 years in the recovery phase of cerebral infarction will be recruited and randomly assigned in a 1:1 ratio to either the study group (n=63, receiving conventional treatment plus Qizhi Jieyu pill) or the control group (n=63, receiving conventional treatment alone). The intervention period will last 12 weeks, and the total follow-up period will be 48 weeks. The primary outcome is the change in the National Institutes of Health Stroke Scale score at week 48. Secondary outcomes include changes in traditional Chinese medicine syndrome scores, the recurrence rate of cerebral infarction, and modified Rankin Scale scores. Adverse events will be recorded and used to assess the safety profile. All data analyses will be performed according to a prespecified statistical analysis plan. RESULTS The study received ethics approval on March 3, 2025, from the Ethics Committee of Guang’anmen Hospital, China Academy of Chinese Medical Sciences (2025-025-KY-01) and was registered on April 6, 2025. Participant recruitment began on April 10, 2025, and is expected to be completed by December 31, 2025. Final results will be published by December 31, 2026. CONCLUSIONS This study is the first randomized controlled clinical trial to evaluate the efficacy and safety of Qizhi Jieyu pill in the treatment of patients during the recovery phase of cerebral infarction. It will contribute to the development of integrated treatment strategies, potentially leading to broader clinical adoption, by providing a high-quality, evidence-based treatment option for clinical practice. CLINICALTRIAL International Traditional Medicine Clinical Trial Registry ITMCTR2025000653; https://itmctr.ccebtcm.org.cn/mgt/project/view/2028021950497347405/false INTERNATIONAL REGISTERED REPORT PRR1-10.2196/75982