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Study on New Scheme and Mechanism of Chronic Insomnia Diagnosis and Treatment: The clinical effect of SD-265 method on adults with insomnia that have difficulty in falling asleep (heart and gallbladder qi deficiency)

注册号：

Registration number：

ITMCTR2000003423

最近更新日期：

Date of Last Refreshed on：

2020-06-20

注册时间：

Date of Registration：

2020-06-20

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

慢性失眠中医诊疗新方案及机制研究方法对成人失眠入睡困难（心胆气虚型）的临床疗效研究

Public title：

Study on New Scheme and Mechanism of Chronic Insomnia Diagnosis and Treatment: The clinical effect of SD-265 method on adults with insomnia that have difficulty in falling asleep (heart and gallbladder qi deficiency)

注册题目简写：

English Acronym：

研究课题的正式科学名称：

慢性失眠中医诊疗新方案及机制研究——SD-265方法对成人失眠入睡困难（心胆气虚型）的临床疗效研究

Scientific title：

Study on New Scheme and Mechanism of Chronic Insomnia Diagnosis and Treatment: the clinical effect of SD-265 method on adults with insomnia that have difficulty in falling asleep (heart and gallbladder qi deficiency)

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：

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：

ChiCTR2000034002 ; ChiMCTR2000003423

申请注册联系人：

陈其凤

研究负责人：

叶永铭

Applicant：

Chen Qifeng

Study leader：

Ye Yongming

申请注册联系人电话：

Applicant telephone：

+86 18310296096

研究负责人电话：

Study leader's telephone：

+86 10-60283731

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：

18310296096@163.com

研究负责人电子邮件：

Study leader's E-mail：

huanyym@126.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：

北京市西城区北线阁街5号

研究负责人通讯地址：

北京市西城区北线阁街5号

Applicant address：

5 North Xiange Street, Xicheng District, Beijing, China

Study leader's address：

5 North Xiange Street, Xicheng District, Beijing, 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：

中国中医科学院广安门医院

Applicant's institution：

Guang'anmen Hospital, China Academy of Chinese Medical Sciences

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：

2019-147-KY-01

伦理委员会批件附件：

Approved file of Ethical Committee：

批准本研究的伦理委员会名称：

中国中医科学院广安门医院伦理委员会

Name of the ethic committee：

Ethics Committee of Guanganmen Hospital, China Academy of Chinese Medical Sciences

伦理委员会批准日期：

Date of approved by ethic committee：

2013/8/26 0:00:00

伦理委员会联系人：

乔洁

Contact Name of the ethic committee：

Qiao Jie

伦理委员会联系地址：

北京市西城区北线阁街5号

Contact Address of the ethic committee：

5 North Xiange Street, Xicheng District, Beijing, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

中国中医科学院广安门医院

Primary sponsor：

Guang'anmen Hospital, China Academy of Chinese Medical Sciences

研究实施负责（组长）单位地址：

北京市西城区北线阁街5号

Primary sponsor's address：

5 North Xiange Street, Xicheng District, Beijing, 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)：

北京

市(区县)：

北京

Country：

China

Province：

Beijing

City：

Beijing

单位(医院)：

中国中医科学院广安门医院

具体地址：

北京市西城区北线阁街5号

Institution
hospital：

Guang'anmen Hospital, China Academy of Chinese Medical Sciences

Address：

5 North Xiange Street, Xicheng District, Beijing, China

经费或物资来源：

国家重点研发计划

Source(s) of funding：

National key R&D plan

研究疾病：

失眠

研究疾病代码：

Target disease：

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：

探索性研究/预试验

Pilot clinical trial

研究目的：

运用独创的SD-256方法治疗成人失眠入睡困难证属心胆气虚型患者，评价其临床效果同时推广该方法

Objectives of Study：

To use the original SD-256 method treat adult patients with insomnia that have difficulty in sleeping due to cardiobiliary qi deficiency. Evaluate the clinical effect and promote the method.

药物成份或治疗方案详述：

对于门诊主诉入睡困难的20-60岁患者于第0-3天，进行72h体动仪监测，对于监测结果提示确实存在入睡困难并符合纳入标准的失眠患者通过随机分组的方式分为两组，一组作为观察组，另一组患者作为对照组。治疗开始前完善匹兹堡睡眠质量指数量表（PSQI）、失眠严重程度指数量表（Insomnia Severity Index，ISI）测试及SD-265患者自评表；第4-10天，观察组进行以温胆汤加减为主方的SD-265方法治疗，对照组单纯接受“温胆汤”随证加减口服中药汤剂治疗，治疗期间持续收集体动仪数据，并填写睡眠数字日志；疗程结束后复测PSQI及ISI量表及SD-265患者自评表。通过治疗前后体动仪监测数据、PSQI及ISI量表及 SD-265患者自评表经过统计分析比较观察组和对照组在疗效上的差异。 SD-265是中西医结合综合干预方法。以认知行为治疗纠正患者对睡眠的错误认知观念，结合患者昼夜节律时辰特点进行光照治疗和运动干预，并在SST思想指导下的将辨证所得一剂汤药依次完成熏、足浴和中药汤剂口服的中医序贯治疗方法。 1.光照方法：光照选取起床后1-2h接受室外自然光照射30min，光照期间禁止佩戴墨镜。 2.运动应于上午至傍晚期间完成，以有氧运动为主，累积运动时间至少30min，晚间禁止进行剧烈运动。 3.浴足方法：将中药煎煮后剩余药液与饮片（或浴足药包）加水煎煮，待水温适宜时浴足（水温40℃），可以轻柔搓洗足底。浴足过程要求水位没过穴位三阴交（内踝尖上方４指）；浴足时间以身体微微发汗为宜，大约15-20分钟左右即可，浴足过程中有任何不适都应立即停止。 4.挥发油导眠方法：煎药过程中，大火煮开后转为小火煎煮后计时，于第5-10分钟开始持续收集药锅锅盖上的挥发油水饱和溶液，大约15-20ml，将其置于香熏容器中，置于床头柜上，选择舒适姿势卧于床上，放松心情，自然呼吸，以达到导眠助眠之目的。 具体操作流程和方法以手册形式发放患者，并嘱患者记录治疗日志。 治疗用药选用温胆汤加减。清半夏9g、陈皮9g、茯苓9g、茯神9g、竹茹9g、枳实9g、菖蒲9g、远志9g、酸枣仁30g、知母9g、生龙骨30g、川芎9g、合欢花9g、黄连3g、甘草6g。中药饮片来源于广安门医院、广安门医院南区中药房，生产单位康美药业。

Description for medicine or protocol of treatment in detail：

The 20-60 year-old patients who complained of falling asleep in the outpatient clinic are monitored on the 0th to 3rd day by 72-hour body motion monitor. The insomnia patients who are found to have difficulty falling asleep and meet the inclusion criteria are randomly divided into two groups by monitoring results. One group serves as the observation group, and the other group serves as the control group. Improve the Pittsburgh Sleep Quality Index Scale (PSQI), Insomnia Severity Index (ISI) test and the SD-265 patient self-assessment table before the start of treatment; on the 4th-10th day, the observation group performed Wendan Tongjia Reduced to the main SD-265 method of treatment, the control group is simply treated with "Wendan Decoction" plus or reduced oral Chinese herbal medicine decoction. During the treatment period, the data of the body movement instrument is continuously collected, and the sleep digital log is filled in; PSQI and ISI scale and SD-265 patient self-assessment scale. Statistical analysis is performed to compare the difference in therapeutic effect between the observation group and the control group through statistical analysis of body motion monitoring data before and after treatment, PSQI and ISI scale, and SD-265 patient self-assessment table. Sd-265 is a comprehensive intervention method of integrated traditional Chinese and Western medicine. To correct the patients' wrong cognition of sleep by cognitive behavior therapy, combined with the characteristics of patients' circadian rhythms and time, to carry out light therapy and exercise intervention, and under the guidance of SST thought, to complete the sequential treatment of traditional Chinese medicine of fumigating, foot bath and oral administration of traditional Chinese Medicine decoction. 1. Lighting method: choose 1-2 hours after getting up to receive outdoor natural light for 30 minutes. It is forbidden to wear sunglasses during the lighting period. 2. Exercise should be completed from morning to evening, mainly aerobic exercise, with accumulated exercise time of at least 30min. Vigorous exercise is prohibited in the evening. 3. Foot bath method: add water to decoct the remaining liquid and decoction pieces (or foot bath medicine package) after decocting the traditional Chinese medicine. When the water temperature is appropriate, bathe the foot (water temperature 40 ℃), and gently scrub the foot. During the foot bath, the water level should not exceed the point Sanyinjiao (4 fingers above the tip of the medial malleolus); the foot bath time should be suitable for the body to sweat slightly, about 15-20 minutes, and any discomfort during the foot bath should be stopped immediately. 4. Method of guiding sleep by volatile oil: in the process of decocting medicine, turn to small fire after boiling, count the time, and continuously collect the saturated solution of volatile oil on the lid of medicine pot from the 5th to 10th minute, about 15-20ml, put it in the fumigant container, put it on the bedside table, choose a comfortable position to lie on the bed, relax the mood, breathe naturally, so as to achieve the purpose of guiding sleep and helping sleep. The specific operation process and method are distributed to patients in the form of manual, and patients are asked to record the treatment log. Wendan Decoction is used for treatment. Qingbanxia 9g, Chenpi 9g, Fuling 9g, Fushen 9g, Zhuru 9g, Zhishi 9g, Changpu 9g, Yuanzhi 9g, Suanzaoren 30g, Anemarrhena 9g, shenglong30g, Chuanxiong 9g, Huanhua 9g, Coptis 3G, liquorice 6G. Chinese herbal pieces come from the traditional Chinese medicine room of Guang'anmen Hospital and South District of Guang'anmen Hospital, and the manufacturer is Kangmei pharmaceutical.

纳入标准：

（1）以入睡困难为主诉，符合原发性失眠症诊断标准； （2）性别不限，年龄在20-60岁； （3）意识清醒、能理解量表内容并配合治疗； （4）自愿接受本临床观察,并签署知情同意书。 中医证型选择参照中华中医药学会中医诊断学分会制定的《中医常见证诊断标准》中的心胆气虚证的诊断，制定以下标准：以失眠、入睡困难为主症，兼见心悸胆怯，不易入睡，寐后易惊。遇事善惊，气短倦怠。舌质淡苔白，脉弦细。

Inclusion criteria

1. Patients with difficulty in falling asleep as the main complaint and meeting the diagnostic criteria of primary insomnia; 2. Patients with unlimited gender, aged 20-60 years; 3. Patients who are conscious, can understand the contents of the scale and cooperate with the treatment; 4. Patients willing to accept the clinical observation and sign the informed consent; The selection of TCM syndrome type refers to the diagnosis of heart and gall deficiency syndrome in the diagnostic standard of common witness of traditional Chinese medicine formulated by the diagnostic branch of Chinese Medicine Society of Chinese medicine, and the following standards are formulated: insomnia and difficulty in falling asleep are the main symptoms, palpitation and timidity are also found, it is not easy to fall asleep, and it is easy to be frightened after falling asleep. When things happen, they are scared and tired. The tongue is light and white with fine veins.

排除标准：

（1）尚未得到有效控制或者严重的疾病如各种原因引起的持续疼痛、恶性肿瘤、心脑血管疾病、神经内分泌疾病等导致的继发性失眠者； （2）严重焦虑和抑郁的患者，精神病患者； （3）怀孕及哺乳期患者； （4）参与其他临床观察者； （5）交流障碍（适用于拟用认知疗法的患者）； （6）存在光敏史 （7）足部皮肤病变 （8）其他原因研究者认为不适宜参加临床试验者 符合上述任意1项者，即予排除。

Exclusion criteria：

1. Patients who have not been effectively controlled or have serious diseases, such as persistent pain caused by various reasons, malignant tumors, cardiovascular and cerebrovascular diseases, neuroendocrine diseases and other secondary insomnia; 2. Patients with severe anxiety and depression, psychosis; 3. Pregnant and lactating patients; 4. Patients participating in other clinical observation; 5. Patients with communication disorders (for patients who plan to use cognitive therapy); 6. Patients with photosensitive history; 7. Patients with foot skin lesions; 8. Patients who are not suitable for clinical trials for other reasons.

研究实施时间：

Study execute time：

从From 2018-12-01

至To      2021-12-31

征募观察对象时间：

Recruiting time：

从From 2021-01-01

至To      2021-07-01

干预措施：

Interventions：

组别：

对照组

样本量：

36

Group：

Control group

Sample size：

干预措施：

温胆汤口服

干预措施代码：

Intervention：

take wendantang orally

Intervention code：

组别：

观察组

样本量：

36

Group：

Experimental group

Sample size：

干预措施：

温胆汤口服+温胆汤水饱和液香薰+泡脚+睡眠认知指导+运动+光照

干预措施代码：

Intervention：

take Wendantang orally+smell the water-saturated Liquid Aroma of wendantang+Foot Soak + Sleep Cognition Guidance + Exercise + Light

Intervention code：

样本总量 Total sample size ： 72

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

北京

市(区县)：

北京

Country：

China

Province：

Beijing

City：

Beijing

单位(医院)：

中国中医科学院广安门医院

单位级别：

三级甲等

Institution/hospital：

Guang'anmen Hospital, China Academy of Chinese Medical Sciences

Level of the institution：

Tertiary A Hospital

国家：

中国

省(直辖市)：

北京

市(区县)：

北京

Country：

China

Province：

Beijing

City：

Beijing

单位(医院)：

中国中医科学院广安门医院南区

单位级别：

三级甲等

Institution/hospital：

South District of Guang'anmen Hospital, China Academy of Chinese Medical Sciences

Level of the institution：

Tertiary A Hospital

测量指标：

Outcomes：

指标中文名：

ISI量表得分

指标类型：

次要指标

Outcome：

ISI scale score

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

PSQI量表得分

指标类型：

次要指标

Outcome：

PSQI scale score

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

体动仪数据

指标类型：

主要指标

Outcome：

Data of Instrument body motion

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

SD-265患者自评表

指标类型：

主要指标

Outcome：

SD-265 patient self-assessment form

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：

无

组织：

Sample Name：

None

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：

尚未开始

Not yet recruiting

年龄范围：

最小 20 岁
Min age years
最大 60 岁
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）：

由医院的国家临床药物试验机构办公室编制随机程序。制作不透光的随机分组信封，顺序号贴在信封外面，随机号及组别则密封于信封内。

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

The randomized procedure is prepared by the hospital's office of the national clinical drug trial institution. Make light-tight random group envelopes, the sequence number is attached to the outside of the envelope, and the random number and group are sealed in the envelope.

盲法：

未说明

Blinding：

Not stated

是否共享原始数据：

IPD sharing：

是

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）：

项目组根据研究进程择期选择具体方式公开原始数据

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

According to the progress of the research,raw research data should be made freely available to all researchers in specific ways

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：

研究者根据受试者的原始观察记录，将数据及时、完整、正确、清晰地载入病例报告表，录入采用相应的数据库系统双人双机录入，之后对数据库进行两遍比对。电子数据文件分类保存，并有多个备份保存于不同磁盘或记录介质上，妥善保存，防止损坏。

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

Based on the original observation records, researchers will completely write accurate data inti case report forms in time. Input the data into corresponding database system by two special researchers with two computers respectively. After that, researchers compare two database twice and electronic data will be conserved and backup.

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):

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