Efficacy and safety of Hehuan Anshen Granules for Chronic Insomnia with Daytime Fatigue: A randomized, Double-Blind, Controlled Trial

注册号:

Registration number:

ITMCTR2025000197

最近更新日期:

Date of Last Refreshed on:

2025-01-27

注册时间:

Date of Registration:

2025-01-27

注册号状态:

Registration Status:

补注册

Retrospective registration

注册题目:

合欢安神颗粒治疗慢性失眠伴日间疲劳患者的 随机、双盲、对照研究

Public title:

Efficacy and safety of Hehuan Anshen Granules for Chronic Insomnia with Daytime Fatigue: A randomized, Double-Blind, Controlled Trial

注册题目简写:

English Acronym:

研究课题的正式科学名称:

合欢安神颗粒治疗慢性失眠伴日间疲劳患者的随机、双盲、对照研究

Scientific title:

Efficacy and safety of Hehuan Anshen Granules for Chronic Insomnia with Daytime Fatigue: A randomized, Double-Blind, Controlled Trial

研究课题的正式科学名称简写:

Scientific title acronym:

研究课题代号(代码):

Study subject ID:

shslczdzk04901

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:

沙中玮

研究负责人:

徐建

Applicant:

Sha Zhongwei

Study leader:

Xu Jian

申请注册联系人电话:

Applicant telephone:

+86 180 4996 2707

研究负责人电话:

Study leader's telephone:

+86 139 0178 1509

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:

shazhongwei1989@163.com

研究负责人电子邮件:

Study leader's E-mail:

xujian0296@163.com

申请单位网址(自愿提供):

Study leader's 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:

上海静安区芷江中路274号

研究负责人通讯地址:

上海静安区芷江中路274号

Applicant address:

274 Middle Zhijiang Road, Jingan District, Shanghai, China

Study leader's address:

274 Middle Zhijiang Road, Jingan District, Shanghai, China

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:

上海市中医医院

Applicant's institution:

Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of TCM

是否获伦理委员会批准:

Approved by ethic committee:

伦理委员会批件文号:

Approved No. of ethic committee:

2023SHL-KY-28-01

伦理委员会批件附件:

Approved file of Ethical Committee:

View

批准本研究的伦理委员会名称:

上海市中医医院伦理委员会

Name of the ethic committee:

Ethic committee of Shanghai Municipal Hospital of Traditional Chinese Medicine

伦理委员会批准日期:

Date of approved by ethic committee:

2023/3/1 0:00:00

伦理委员会联系人:

凌丽

Contact Name of the ethic committee:

Ling Li

伦理委员会联系地址:

上海静安区芷江中路274号

Contact Address of the ethic committee:

274 Middle Zhijiang Road, Jingan District, Shanghai, China

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 21 5662 8310

伦理委员会联系人邮箱:

Contact email of the ethic committee:

szyjxc2022@163.com

研究实施负责(组长)单位:

上海市中医医院

Primary sponsor:

Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of TCM

研究实施负责(组长)单位地址:

上海静安区芷江中路274号

Primary sponsor's address:

274 Middle Zhijiang Road, Jingan District, Shanghai, China

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海市中医医院

具体地址:

上海静安区芷江中路274号

Institution
hospital:

Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of TCM

Address:

274 Middle Zhijiang Road, Jingan District, Shanghai, China

经费或物资来源:

上海市临床重点专科建设项目

Source(s) of funding:

Shanghai Municipal Key Clinical Specialty

研究疾病:

慢性失眠

研究疾病代码:

Target disease:

chronic insomnia

Target disease code:

研究类型:

Study type:

干预性研究

Interventional study

研究设计:

Study design:

随机平行对照

randomized controlled trial(parallel group design)

研究所处阶段:

Study phase:

其它

Others

研究目的:

通过随机、双盲、对照研究评价合欢安神颗粒治疗慢性失眠伴日间疲劳患者的临床疗效及安全性,进一步发掘失眠障碍的有效治疗方法具有重要的临床应用价值。

Objectives of Study:

Through a randomized, double-blind, controlled clinical trial, the clinical efficacy and safety of Hehuan Anshen Granules for chronic insomnia with daytime fatigue is evaluated, and it is of great significance to find an effective intervention for chronic insomnia.

药物成份或治疗方案详述:

治疗组:合欢安神颗粒,温开水冲服200ml,一次1袋,一日2次。 对照组:极低剂量(10%)合欢安神颗粒,主要成分为10%浓度合欢安神颗粒,每袋温开水冲服200ml,一次1袋,一日2次。

Description for medicine or protocol of treatment in detail:

纳入标准:

(1) 受试者,男女均可,年龄18岁以上; (2) 意识清晰,听觉正常,能够理解并参与相关量表的评估; (3) 符合睡眠障碍国际分类(第3版)ICSD-3慢性失眠障碍的诊断标准且伴有日间疲劳; (4) 参照《中医内科学》符合“不寐病”的中医诊断标准,符合肝火扰心证、痰热扰心证、心脾两虚证、心肾不交证、心胆气虚证等证型。 (5) 匹兹堡睡眠指数量表(PSQI)总分8分以上; (6) 弗林德斯疲劳量表(FFS)总分≥15分; (7) 自愿参加,签署知情同意书。

Inclusion criteria

1. Male and female participants aged >= 18 years; 2. Clear consciousness normal hearing and visual abilities are maintained and have the ability to participate in the neuropsychological activity test; 3. Participants meet diagnostic criteria for Chronic insomnia in ICSD-3 and with daytime fatigue at the same time. 4. According to the "internal medicine of traditional Chinese medicine" it meets the diagnostic criteria of "insomnia disease" and conforms to the syndrome types of liver fire disturbing the heart phlegm heat disturbing the heart deficiency of both heart and spleen heart kidney disharmony deficiency of heart and gallbladder Qi etc. 5.The total score of PSQI is above 8; 6. The total score of FFS is above 14; 7. Participants agree to sign the informed consent form and volunteer for this study

排除标准:

(1) 其他睡眠障碍,如发作性睡病、睡眠呼吸暂停综合征或睡眠相关运动障碍等; (2) 任何重度精神疾病史; (3) 有明显的抑郁症状,贝克抑郁症量表-II(BDI)抑郁量表评分>29分; (4) 有药物、酒精依赖、成瘾或对本研究药物过敏者; (5) 正在服用抗精神病药物的患者; (6) 正服用其他临床试验药物的参与者,或停止试验后的清洗期<2周; (7) 有严重的胃肠道疾病(如消化不良、胃肠道梗阻、胃和十二指肠溃疡)以及其他影响药物吸收的胃肠道疾病; (8) 合并有肝肾功能不全,糖尿病,严重的神经系统疾病,心血管系统疾病,自身免疫性疾病以及其他禁忌症者; (9) 怀孕、哺乳或在研究中可能怀孕不能采取有效避孕措施的妇女。

Exclusion criteria:

(1) Participants with other sleep disorders such as narcolepsy sleep apnea syndrome or sleep related motor disorders; (2) Participants with Any history of severe mental illness; (3) Participants with obvious depressive symptoms with a score of>29 on the Beck Depression Inventory II (BDI) Depression Scale; (4) Participants with medication alcohol dependence addiction or allergies to the drugs in this study; (5)Participants were taking antipsychotic medication that impact the assessment of efficacy; (6) Any participant on treatment were withdrawn from other clinical drug trials before the first study-drug administration were less than 2 weeks. (7) Participants with serious gastrointestinal diseases (such as indigestion gastrointestinal obstruction gastroduodenal ulceration) and serious secondary diseases that affect drug absorption; (8) Participants comprised hepatic and renal dysfunction severe neurological diseases cardiovascular and cerebrovascular diseases' complication as well as a history of other autoimmune diseases and any other contraindication; (9) Female participants who are pregnant breastfeeding or may not be able to take effective contraceptive measures during research

研究实施时间:

Study execute time:

From 2023-05-11

To      2024-10-23

征募观察对象时间:

Recruiting time:

From 2024-05-11

To      2024-10-23

干预措施:

Interventions:

组别:

对照组

样本量:

97

Group:

Controlled group

Sample size:

干预措施:

10%合欢安神颗粒

干预措施代码:

Intervention:

Hehuan Anshen granules with a 10% drug concentration

Intervention code:

组别:

治疗组

样本量:

97

Group:

Experimental group

Sample size:

干预措施:

合欢安神颗粒

干预措施代码:

Intervention:

Hehuan Anshen granules

Intervention code:

样本总量 Total sample size : 194

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海市中医医院

单位级别:

三甲

Institution/hospital:

Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of TCM

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

细胞因子

指标类型:

附加指标

Outcome:

Cytokine

Type:

Additional indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血常规、肝、肾功能、尿常规、心电图

指标类型:

副作用指标

Outcome:

routine blood, liver function (alanine aminotransferase (ALT) and aspartate aminotransferase (AST)), renal function (blood urea nitrogen (BUN) and creatinine (Cr)), urine and electrocardiograms

Type:

Adverse events

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

疲劳严重程度量表

指标类型:

次要指标

Outcome:

Fatigue Severity Scale

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

近红外脑功能成像

指标类型:

附加指标

Outcome:

Functional near-infrared spectroscopy,fNIRS

Type:

Additional indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

中医症状量表

指标类型:

次要指标

Outcome:

Traditional Chinese Medicine Symptom Scale

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

匹兹堡睡眠指数(PSQI)量表

指标类型:

主要指标

Outcome:

Pittsburgh Sleep Index Scale

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

弗林德斯疲劳量表

指标类型:

次要指标

Outcome:

Flinders Fatigue Scale

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

失眠严重程度(ISI)量表

指标类型:

次要指标

Outcome:

Insomnia Severity Scale

Type:

Secondary 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:

血液

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:

标本中文名:

尿液

组织:

Sample Name:

Urine

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:

结束

Completed

年龄范围:

最小 18
Min age years
最大 81
Max age years

Recruiting status:

Participant age:

性别:

Gender:

男女均可

Both

随机方法(请说明由何人用什么方法产生随机序列):

指将由计算机软件SPSS产生的随机数字与序号(1,2,3,……)对应所组成的随机数字序列的所有随机数字指定为A组或B组,A组或B组再指定为试验组或对照组并记录在案;确定随机数字的分组必须由专人执行;确定并记录有分组信息的表称为“随机分配表”。

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

The random allocation table was performed with SPSS computer software. All random numbers corresponding to the composed random number sequence are designated as Group A or Group B, and Group A or Group B are then designated as the experimental or control group and recorded; The grouping of random numbers must be carried out by dedicated personnel; A table that identifies and records grouping information is called a "random allocation table".

盲法:

由专人对药品进行分装编盲。为每个受试者分配一个药袋,药袋中包含治疗期内所有的用药。药袋的标签上写上编号,袋内所有药品的标签上也写上相同编号。试验组与对照组按照1:1设计时,一般采用两次揭盲法,数据文件经过盲态审核并认定可靠无误后将被锁定,进行第一次揭盲,此次揭盲只列出每个病例所属的组别(A组或B组);统计分析结束后进行第二次揭盲,以明确哪一个为试验组或对照组;全部盲底一旦泄露或应急信件拆阅率超过20%时,意味着该双盲试验失效。课题组为每个受试者准备一个应急信件,信封标有受试者的药物编号,内密封的信纸注明了该受试者的所属组别,供紧急揭盲时用。各个应急信件随相应编号的药物由专人管理。研究者需按分配的药品编号,按受试者入组次序先后依次使用。盲底保存:盲底密封后交由申办者上海市中医医院设专人管理保存。

Blinding:

According to the above-mentioned blind method, the special personnel will divide the drugs into two groups. Each subject will be assigned a medicine bag, which has contained all medication during the treatment period. The label of the medicine bag should be numbered, and the label of all drugs in the bag should also be written with the same number. Once the blind bottoms are leaked or the opening rate of emergency letters exceeds 20%, it means that the double-blind test is invalid. The researcher should distribute the drugs according to the drug number and the order of the subjects. After sealing, the blind bottom will be delivered to the sponsor Shanghai Municipal Hospital of Traditional Chinese Medicine and managed by a specially assigned person.

是否共享原始数据:

IPD sharing:

Yes

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):

http://www.medresman.org.cn/login.aspx。公开日期:论文发表后

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

Publication date: after the publication of the paper;http://www.medresman.org.cn/login.aspx

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:

采用病例记录表(CRF)对数据进行采集,后导入excel进行数据分析

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

The data were collected by case record form (CRF) and imported into Excel for data analysis

数据管理委员会:

Data Managemen Committee:

暂未确定

Not yet

研究计划书或研究结果报告发表信息
(杂志名称、期、卷、页,时间;或网址):

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

ITMCTR BJ-ICP:07032215-5 Tip: IE8 is recommended Use the system with widescreen display resolution above