Qizhi Jieyu Pill for the Treatment of Cerebral Infarction During the Recovery Phase: Protocol for a Randomized Controlled Clinical Trial
BackgroundCerebral 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 per...
Saved in:
| Main Authors: | , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
JMIR Publications
2025-08-01
|
| Series: | JMIR Research Protocols |
| Online Access: | https://www.researchprotocols.org/2025/1/e75982 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1849770969653051392 |
|---|---|
| author | Xuedong An Liangqing Yu Yuqin Ma Junwei Zhang Shiping Guo Jilong Xu Ping Zhao Hongyan Xu Feng Gao Xueqin Wu Yanlan Gao Yao Jiang Yali Liu |
| author_facet | Xuedong An Liangqing Yu Yuqin Ma Junwei Zhang Shiping Guo Jilong Xu Ping Zhao Hongyan Xu Feng Gao Xueqin Wu Yanlan Gao Yao Jiang Yali Liu |
| author_sort | Xuedong An |
| collection | DOAJ |
| description |
BackgroundCerebral 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.
ObjectiveThis 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.
MethodsThis 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.
ResultsThe 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.
ConclusionsThis 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 RegistrationInternational 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 |
| format | Article |
| id | doaj-art-cafe5619c573468fbfec0cc4bad9ec6c |
| institution | DOAJ |
| issn | 1929-0748 |
| language | English |
| publishDate | 2025-08-01 |
| publisher | JMIR Publications |
| record_format | Article |
| series | JMIR Research Protocols |
| spelling | doaj-art-cafe5619c573468fbfec0cc4bad9ec6c2025-08-20T03:02:47ZengJMIR PublicationsJMIR Research Protocols1929-07482025-08-0114e7598210.2196/75982Qizhi Jieyu Pill for the Treatment of Cerebral Infarction During the Recovery Phase: Protocol for a Randomized Controlled Clinical TrialXuedong Anhttps://orcid.org/0000-0002-2787-1645Liangqing Yuhttps://orcid.org/0009-0008-0122-1469Yuqin Mahttps://orcid.org/0009-0006-6512-4225Junwei Zhanghttps://orcid.org/0009-0005-8123-307XShiping Guohttps://orcid.org/0009-0004-2933-7931Jilong Xuhttps://orcid.org/0009-0001-0078-6969Ping Zhaohttps://orcid.org/0009-0009-3392-5468Hongyan Xuhttps://orcid.org/0009-0004-0185-6289Feng Gaohttps://orcid.org/0009-0007-1155-0904Xueqin Wuhttps://orcid.org/0009-0009-9553-4091Yanlan Gaohttps://orcid.org/0009-0002-6448-6110Yao Jianghttps://orcid.org/0009-0009-2794-737XYali Liuhttps://orcid.org/0009-0003-7616-7683 BackgroundCerebral 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. ObjectiveThis 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. MethodsThis 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. ResultsThe 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. ConclusionsThis 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 RegistrationInternational Traditional Medicine Clinical Trial Registry ITMCTR2025000653; https://itmctr.ccebtcm.org.cn/mgt/project/view/2028021950497347405/false International Registered Report Identifier (IRRID)PRR1-10.2196/75982https://www.researchprotocols.org/2025/1/e75982 |
| spellingShingle | Xuedong An Liangqing Yu Yuqin Ma Junwei Zhang Shiping Guo Jilong Xu Ping Zhao Hongyan Xu Feng Gao Xueqin Wu Yanlan Gao Yao Jiang Yali Liu Qizhi Jieyu Pill for the Treatment of Cerebral Infarction During the Recovery Phase: Protocol for a Randomized Controlled Clinical Trial JMIR Research Protocols |
| title | Qizhi Jieyu Pill for the Treatment of Cerebral Infarction During the Recovery Phase: Protocol for a Randomized Controlled Clinical Trial |
| title_full | Qizhi Jieyu Pill for the Treatment of Cerebral Infarction During the Recovery Phase: Protocol for a Randomized Controlled Clinical Trial |
| title_fullStr | Qizhi Jieyu Pill for the Treatment of Cerebral Infarction During the Recovery Phase: Protocol for a Randomized Controlled Clinical Trial |
| title_full_unstemmed | Qizhi Jieyu Pill for the Treatment of Cerebral Infarction During the Recovery Phase: Protocol for a Randomized Controlled Clinical Trial |
| title_short | Qizhi Jieyu Pill for the Treatment of Cerebral Infarction During the Recovery Phase: Protocol for a Randomized Controlled Clinical Trial |
| title_sort | qizhi jieyu pill for the treatment of cerebral infarction during the recovery phase protocol for a randomized controlled clinical trial |
| url | https://www.researchprotocols.org/2025/1/e75982 |
| work_keys_str_mv | AT xuedongan qizhijieyupillforthetreatmentofcerebralinfarctionduringtherecoveryphaseprotocolforarandomizedcontrolledclinicaltrial AT liangqingyu qizhijieyupillforthetreatmentofcerebralinfarctionduringtherecoveryphaseprotocolforarandomizedcontrolledclinicaltrial AT yuqinma qizhijieyupillforthetreatmentofcerebralinfarctionduringtherecoveryphaseprotocolforarandomizedcontrolledclinicaltrial AT junweizhang qizhijieyupillforthetreatmentofcerebralinfarctionduringtherecoveryphaseprotocolforarandomizedcontrolledclinicaltrial AT shipingguo qizhijieyupillforthetreatmentofcerebralinfarctionduringtherecoveryphaseprotocolforarandomizedcontrolledclinicaltrial AT jilongxu qizhijieyupillforthetreatmentofcerebralinfarctionduringtherecoveryphaseprotocolforarandomizedcontrolledclinicaltrial AT pingzhao qizhijieyupillforthetreatmentofcerebralinfarctionduringtherecoveryphaseprotocolforarandomizedcontrolledclinicaltrial AT hongyanxu qizhijieyupillforthetreatmentofcerebralinfarctionduringtherecoveryphaseprotocolforarandomizedcontrolledclinicaltrial AT fenggao qizhijieyupillforthetreatmentofcerebralinfarctionduringtherecoveryphaseprotocolforarandomizedcontrolledclinicaltrial AT xueqinwu qizhijieyupillforthetreatmentofcerebralinfarctionduringtherecoveryphaseprotocolforarandomizedcontrolledclinicaltrial AT yanlangao qizhijieyupillforthetreatmentofcerebralinfarctionduringtherecoveryphaseprotocolforarandomizedcontrolledclinicaltrial AT yaojiang qizhijieyupillforthetreatmentofcerebralinfarctionduringtherecoveryphaseprotocolforarandomizedcontrolledclinicaltrial AT yaliliu qizhijieyupillforthetreatmentofcerebralinfarctionduringtherecoveryphaseprotocolforarandomizedcontrolledclinicaltrial |