Qizhi Jieyu Pill for the Treatment of Cerebral Infarction During the Recovery Phase: Protocol for a Randomized Controlled Clinical Trial
Bibliographic record
Abstract
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. TRIAL REGISTRATION: International Traditional Medicine Clinical Trial Registry ITMCTR2025000653; https://itmctr.ccebtcm.org.cn/mgt/project/view/2028021950497347405/false. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/75982.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.040 | 0.031 |
| Meta-epidemiology (narrow) | 0.007 | 0.003 |
| Meta-epidemiology (broad) | 0.011 | 0.006 |
| Bibliometrics | 0.003 | 0.004 |
| Science and technology studies | 0.004 | 0.004 |
| Scholarly communication | 0.004 | 0.003 |
| Open science | 0.004 | 0.002 |
| Research integrity | 0.008 | 0.008 |
| Insufficient payload (model declined to judge) | 0.040 | 0.008 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".