ChiCTR2600122495 版本V1.0 版本创建时间2026/04/14 14:50:59 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2600122495 

最近更新日期：

Date of Last Refreshed on：

 2026-04-14 14:50:51 

注册时间：

Date of Registration：

 2026-04-14 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

舒肝解郁胶囊治疗卒中后抑郁的神经生物学机制探索研究

Public title：

Exploration study on the neurobiological mechanism of Shugan Jieyu Capsules in the treatment of post-stroke depression

注册题目简写：

English Acronym：

研究课题的正式科学名称：

舒肝解郁胶囊治疗卒中后抑郁的神经生物学机制探索：一项前瞻性、多模态、自身前后对照研究

Scientific title：

Exploration of the neurobiological mechanism of Shugan Jieyu Capsules in the treatment of post-stroke depression: A prospective, multimodal, self-controlled before-after study

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

周子懿 

研究负责人：

周子懿 

Applicant：

Ziyi Zhou 

Study leader：

Ziyi Zhou 

申请注册联系人电话：

Applicant telephone：

 +86 13751829183

研究负责人电话：

Study leader's
telephone：

+86 20 8188 7233

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

 zizi_33@126.com

研究负责人电子邮件：

Study leader's E-mail：

 zizi_33@126.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

广东省广州市越秀区大德路111号

研究负责人通讯地址：

广东省广州市越秀区大德路111号

Applicant address：

No. 111, Dade Road, Yuexiu District, Guangzhou City, Guangdong Province

Study leader's address：

No. 111, Dade Road, Yuexiu District, Guangzhou City, Guangdong Province

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

广东省广州市越秀区大德路111号

Applicant's institution：

No. 111, Dade Road, Yuexiu District, Guangzhou City, Guangdong Province

研究负责人所在单位：

广东省中医院

Affiliation of the Leader：

Guangdong Provincial Hospital of Chinese Medicine

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 广东省中医院伦理委员会BF2026-031-01

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

广东省中医院伦理委员会

Name of the ethic committee：

Ethics Committee of Guangdong Provincial Hospital of Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

 2026-01-30 00:00:00

伦理委员会联系人：

李晓彦

Contact Name of the ethic committee：

Li XiaoYan

伦理委员会联系地址：

广东省广州市越秀区大德路111号

Contact Address of the ethic committee：

No. 111, Dade Road, Yuexiu District, Guangzhou City, Guangdong Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 20 81887233

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 15913123537@163.com

研究实施负责（组长）单位：

广东省中医院

Primary sponsor：

Guangdong Provincial Hospital of Chinese Medicine

研究实施负责（组长）单位地址：

广东省广州市越秀区大德路111号

Primary sponsor's address：

No. 111, Dade Road, Yuexiu District, Guangzhou City, Guangdong Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

广东省

市(区县)：

Country：

China

Province：

Guangdong

City：

单位(医院)：

广东省中医院

具体地址：

广东省广州市越秀区大德路111号

Institution
hospital：

Guangdong Provincial Hospital of Chinese Medicine

Address：

No. 111, Dade Road, Yuexiu District, Guangzhou City, Guangdong Province

经费或物资来源：

四川济生堂药业有限公司

Source(s) of funding：

Sichuan Jishengtang Pharmaceutical Co., Ltd.

研究疾病：

卒中后抑郁  

Target disease：

Post-stroke depression

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 上市后药物 

Study phase：

4

研究设计：

单臂 

Study design：

Single arm 

研究目的：

主要目的：评估舒肝解郁胶囊对PSD患者抑郁症状的改善效果。 次要目的：评估其对神经功能、认知功能及生活质量的改善。 探索性目的：通过磁共振及外周血生物标志物，探索药物对大脑网络功能、神经损伤修复及炎症状态的影响，并分析这些生物学改变与临床症状改善的相关性。  

Objectives of Study：

Primary objective: To evaluate the improvement effect of Shugan Jieyu Capsules on depressive symptoms in patients with PSD. Secondary objective: To evaluate its improvement on neurological function, cognitive function and quality of life. Exploratory objective: To explore the effects of the drug on brain network function, nerve injury repair and inflammatory status through magnetic resonance imaging and peripheral blood biomarkers, and to analyze the correlation between these biological changes and the improvement of clinical symptoms.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

PSD 给药组： 1.18≤年龄≤80岁； 2. 既往1年内确诊缺血性卒中，且有颅脑MRI或CT证实； 3. 符合DSM-Ⅴ“由于其他躯体疾病（卒中）所致的抑郁障碍”诊断标准，症状持续≥2周； 4.7<汉密尔顿抑郁量表17项(HAMD-17)得分<24； 5. 能配合随访； 6. 签署知情同意书。 健康志愿者组： 1. 18≤年龄≤80 岁； 2. HAMD-17 得分<7； 3. 体重指数（BMI）在 19.0 - 26.0kg/m2 范围内； 4. 体格检查、生命体征、实验室检查、心电图等结果未见异常； 5. 能配合随访； 6. 签署知情同意书。

Inclusion criteria

PSD administration group: 1.18 ≤ age ≤ 80 years old; 2. Diagnosed with ischemic stroke within the past 1 year, confirmed by brain MRI or CT; 3.Meeting DSM-5 diagnostic criteria for depressive disorder due to another medical condition (stroke), with symptoms lasting ≥ 2 weeks; 4.7 < Hamilton Depression Rating Scale (HAMD-17) score < 24; 5.Able to cooperate with follow-up; 6.Signed the informed consent form. Healthy Volunteer Group: 1. Age between 18 and 80 years; 2. HAMD-17 score < 7; 3. Body Mass Index (BMI) between 19.0 - 26.0 kg/m2; 4. No abnormalities found in physical examination, vital signs, laboratory tests, ECG, etc.; 5. Able to cooperate with follow-up; 6. Signed informed consent form.

排除标准：

PSD 给药组： 1.有明确诊断的原发性精神障碍病史，如：精神分裂症谱系及其他精神病性障碍（如：精神分裂症、分裂情感性障碍、短暂精神病性障碍），双相及相关障碍（如：双相Ⅰ型障碍、双相Ⅱ型障碍），强迫症，创伤后应激障碍（与本次卒中无关的既往发作）； 2.非血管性原因引起的脑功能障碍：如原发性脑肿瘤、脑转移瘤、硬膜下血肿、癫痫发作后意识障碍、脑外伤等造成的脑功能障碍； 3.卒中前抑郁史； 4.有严重自杀意念或行为； 5.既往癫痫病史或家族性癫痫病史； 6.入组前2周内使用过抗抑郁药物、接受过电休克疗法或重复经颅磁刺激治疗的患者； 7.智力低下、患有严重痴呆（MMSE<=9分）、失语、意识障碍等无法配合完成随访； 8.存在中重度至重度残疾，经mRS（改良Rankin量表）评估，在筛选期得分 ≥ 4分者； 9.严重肝肾功能不全：丙氨酸转氨酶（ALT）或天冬氨酸转氨酶（AST）＞2.0倍正常值上限，和/或其它已知肝脏疾病如急慢性肝炎、肝硬化等；血清肌酐>2.0×ULN，和/或已知的严重肾功不全疾病； 10.其他威胁生命的严重疾病：如恶性肿瘤、血液、消化或其他系统严重疾病等，预期生存时间不超过 3 个月者； 11.妊娠、计划妊娠或哺乳期妇女； 12.已知舒肝解郁胶囊及其成分（刺五加、贯叶金丝桃/圣约翰草）过敏者，或有严重过敏史者； 13.存在或疑似有酒精或药物滥用史； 14.入组前3个月内参加过其他临床试验，或正在参加其他临床试验； 15.研究者判断不适合参加本研究的其他情况。 健康志愿者组： 1. 有明确诊断的原发性精神障碍病史，如：精神分裂症谱系及其他精神病性障碍（如：精神分裂症、分裂情感性障碍、短暂精神病性障碍），双相及相关障碍（如：双相Ⅰ型障碍、双相Ⅱ型障碍），强迫症，创伤后应激障碍（与本次卒中无关的既往发作）； 2. 非血管性原因引起的脑功能障碍：如原发性脑肿瘤、脑转移瘤、硬膜下血肿、癫痫发作后意识障碍、脑外伤等造成的脑功能障碍； 3. 卒中前抑郁史； 4. 有严重自杀意念或行为； 5. 既往癫痫病史或家族性癫痫病史； 6. 入组前 2 周内使用过抗抑郁药物、接受过电休克疗法或重复经颅磁刺激治疗的患者； 7. 智力低下、患有严重痴呆（MMSE<=9 分）、失语、意识障碍等无法配合完成随访； 8. 存在中重度至重度残疾，经 mRS（改良 Rankin 量表）评估，在筛选期得分 ≥ 4 分 者； 9. 严重肝肾功能不全：丙氨酸转氨酶（ALT）或天冬氨酸转氨酶（AST）＞2.0 倍正常值上限，和/或其它已知肝脏疾病如急慢性肝炎、肝硬化等；血清肌酐>2.0×ULN，和/或已知的严重肾功不全疾病； 10. 其他威胁生命的严重疾病：如恶性肿瘤、血液、消化或其他系统严重疾病等，预期生存时间不超过 3 个月者； 11. 妊娠、计划妊娠或哺乳期妇女； 12. 存在或疑似有酒精或药物滥用史； 13. 入组前 3 个月内参加过其他临床试验，或正在参加其他临床试验； 14. 研究者判断不适合参加本研究的其他情况。

Exclusion criteria：

PSD administration group: 1.History of clearly diagnosed primary psychiatric disorders, such as schizophrenia spectrum and other psychotic disorders (e.g., schizophrenia, schizoaffective disorder, brief psychotic disorder), bipolar and related disorders (e.g., bipolar I disorder, bipolar II disorder), obsessive-compulsive disorder, or post-traumatic stress disorder (previous episodes unrelated to the current stroke); 2.Brain dysfunction caused by non-vascular reasons, such as brain dysfunction caused by primary brain tumors, brain metastases, subdural hematomas, impaired consciousness following epileptic seizures, or brain trauma; 3.A history of depression prior to the stroke; 4.Severe suicidal ideation or behavior; 5.A personal or family history of epilepsy; 6.Patients who have used antidepressants, received electroconvulsive therapy or repetitive transcranial magnetic stimulation therapy within 2 weeks before enrollment; 7.Unable to cooperate with follow-up due to intellectual disability, severe dementia (MMSE score ≤ 9), aphasia, impaired consciousness, etc.; 8.Those with moderate-to-severe disability, scoring ≥ 4 on the modified Rankin Scale (mRS) during the screening period; 9.Severe hepatic or renal insufficiency: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.0 times the upper limit of normal, and/or other known liver diseases such as acute or chronic hepatitis, cirrhosis; serum creatinine > 2.0 × ULN, and/or known severe renal insufficiency; 10.Other life-threatening severe diseases, such as malignant tumors, severe diseases of the blood, digestive system, or other systems, with an expected survival time of less than 3 months; 11.Pregnant, planning to become pregnant or lactating women; 12.Known allergy to Shugan Jieyu Capsules or their ingredients (Eleutherococcus senticosus, Hypericum perforatum L./St. John’s wort), or a history of severe allergies; 13.Those with a history of or suspected history of alcohol or drug abuse; 14.Those who have participated in other clinical trials within 3 months before enrollment, or are currently participating in other clinical trials; 15.Other conditions judged by the investigator as unsuitable for participation in this study. Healthy Volunteer Group: 1. History of clearly diagnosed primary psychiatric disorders, such as: schizophrenia spectrum and other psychotic disorders (e.g., schizophrenia, schizoaffective disorder, brief psychotic disorder), bipolar and related disorders (e.g., bipolar I disorder, bipolar II disorder), obsessive-compulsive disorder, post-traumatic stress disorder (previous episodes unrelated to the current stroke); 2. Brain dysfunction caused by non-vascular reasons: such as primary brain tumors, brain metastases, subdural hematomas, post-seizure consciousness disorders, brain injury, etc.; 3. History of depression before stroke; 4. Severe suicidal ideation or behavior; 5. History of epilepsy or family history of epilepsy; 6. Use of antidepressant medication, or received electroconvulsive therapy or repeated transcranial magnetic stimulation within 2 weeks before enrollment; 7. Intellectual disability, severe dementia (MMSE <=9), aphasia, consciousness disorders, or other conditions preventing cooperation with follow-up; 8. Moderate to severe disability, assessed by mRS (modified Rankin Scale) with a score of ≥ 4 during the screening period; 9. Severe liver or kidney dysfunction: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.0 times the upper limit of normal, and/or other known liver diseases such as acute or chronic hepatitis, cirrhosis; serum creatinine > 2.0 × ULN, and/or other known severe renal dysfunction; 10. Other life-threatening serious diseases: such as malignant tumors, severe hematologic, digestive, or other systemic diseases, with an expected survival time of no more than 3 months; 11. Pregnant women, women planning pregnancy, or breastfeeding women; 12. History or suspicion of alcohol or substance abuse; 13. Participation in other clinical trials within 3 months prior to enrollment, or currently participating in other clinical trials; 14. Other situations deemed by the investigator to be unsuitable for participating in this study.

研究实施时间：

Study execute time：

从 From 2026-03-20 00:00:00至 To 2028-12-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-04-30 00:00:00 至 To 2026-12-31 00:00:00

干预措施：

Interventions：

组别：

PSD患者组（干预组）

样本量：

 32

Group：

PSD group(Intervention group)

Sample size：

干预措施：

患者口服舒肝解郁胶囊（一次 2 粒，一日 2 次），疗程为 12 周。同时，所有患者接受标准卒中二级预防及康复治疗。

干预措施代码：

Intervention：

Patients took Shugan Jieyu Capsules orally (2 capsules per dose, twice a day) for a duration of 12 weeks. At the same time, all patients received standard secondary stroke prevention and rehabilitation treatment.

Intervention code：

组别：

健康志愿者

样本量：

 16

Group：

Healthy Volunteer Group

Sample size：

干预措施：

无

干预措施代码：

Intervention：

No

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 广东省 

市(区县)：

  

Country：

China

Province：

Guangdong

City：

单位(医院)：

 广东省中医院 

单位级别：

 三级甲等 

Institution
hospital：

Guangdong Provincial Hospital of Chinese Medicine

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

治疗12周后汉密尔顿抑郁量表（HAMD-17）评分较基线的变化值。

指标类型：

主要指标

Outcome：

Change from baseline in the Hamilton Depression Rating Scale (HAMD-17) score after 12 weeks of treatment.

Type：

Primary indicator

测量时间点：

12周

测量方法：

Measure time point of outcome：

12 weeks

Measure method：

指标中文名：

mRS、HAMA、PSQI、MoCA、MMSE、SSS、FSS、 ESS、MAES 评分变化

指标类型：

主要指标

Outcome：

Changes in mRS, HAMA, PSQI, MoCA, MMSE, SSS, FSS, ESS, and MAES scores

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血

组织：

Sample Name：

Blood

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 80 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

无

Randomization Procedure (please state who generates the random number sequence and by what method)：

None

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

无

Blinding：

None

是否共享原始数据：

IPD sharing

否No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

不共享

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

Not shared

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

采用EDC系统采集数据，实施源数据核查与逻辑核查，不良事件及合并用药采用国际通用字典编码，数据库锁定后统计分析。资料保存10年。如因资源或技术原因无法使用EDC系统，可采用纸质病例报告表（CRF）作为备选方案，具体实施时须遵循以下要求：采用统一纸质CRF，由研究者规范填写；数据由双人独立录入Excel数据库并进行交叉核对；对存疑数据查阅源文件确认；所有原始资料归档保存，保存期限10年。

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Data will be collected using an Electronic Data Capture (EDC) system. Source data verification (SDV) and logic checks will be performed. Adverse events and concomitant medications will be coded using internationally recognized dictionaries. Statistical analysis will be conducted after database lock. All study documents will be retained for 10 years.If the EDC system cannot be implemented due to resource or technical limitations, a paper-based Case Report Form (CRF) may be used as an alternative. In such cases, the following requirements must be adhered to: a standardized paper CRF shall be used and completed by the investigator in accordance with the guidelines; data shall be entered independently by two individuals into an Excel database and cross-validated; any questionable data shall be verified against source documents; all original records shall be archived and retained for a period of 10 years.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2026-04-14 14:50:51