JMIR Publications

ABSTRACT

Background:

Cerebral infarction, as 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, 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. Therefore, we have designed a randomized controlled clinical trial to evaluate the efficacy and safety of Qizhi Jieyu Pill in patients during the recovery phase of cerebral infarction.

Objective:

Therefore, we have designed a randomized controlled clinical trial 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 + 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 NIHSS (National Institutes of Health Stroke Scale) score at week 48. Secondary outcomes include changes in traditional Chinese medicine (TCM) syndrome scores, recurrence rate of cerebral infarction, and changes in the modified Rankin Scale (mRS). Adverse events will be recorded and used to assess the safety profile. All data analyses will be performed according to a pre-specified statistical analysis plan.

Results:

Recruitment for the study has not yet started. Ethical approval has been obtained from the Ethics Committee of Guang’anmen Hospital, China Academy of Chinese Medical Sciences (2025-025-KY-01), and the study has been registered on the International Traditional Medicine Clinical Trial Registry platform (ITMCTR2025000653). Results are expected to be published by December 31, 2026. This study aims to evaluate the efficacy and safety of Qizhi Jieyu Pill in patients during the recovery phase of cerebral infarction, providing a high-quality evidence-based treatment option for clinical practice.

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 developing integrated treatment strategies, potentially leading to broader clinical adoption. Clinical Trial: trial has been registered on the ITMCTR website (ITMCTR2025000653).