ChiCTR2400082110 版本V1.0 版本创建时间2024/03/21 08:33:54 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：

ChiCTR2400082110 

最近更新日期：

Date of Last Refreshed on：

2024-03-21 08:33:48 

注册时间：

Date of Registration：

2024-03-21 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

“俞募配穴”针刺治疗乳腺癌术后失眠的临床疗效评价及其机制探讨

Public title：

Clinical evaluation and mechanism of "Shu Mu point combination" acupuncture in the treatment of insomnia after breast cancer surgery

注册题目简写：

针刺治疗乳腺癌术后失眠的疗效评价及机制探讨

English Acronym：

Evaluation of the therapeutic effect of acupuncture on insomnia after breast cancer surgery and its mechanism

研究课题的正式科学名称：

“俞募配穴”为主针刺治疗乳腺癌患者术后失眠的临床疗效评价及其机制探讨

Scientific title：

Clinical evaluation and mechanism of acupuncture based on "Shu Mu point combination" in the treatment of postoperative insomnia in patients with breast cancer

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：

李洁 

研究负责人：

陈云飞 

Applicant：

LiJie 

Study leader：

ChenYunfei 

申请注册联系人电话：

Applicant telephone：

+86 138 2011 3039

研究负责人电话：

Study leader's telephone：

+86 139 1792 2206

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：

3493511425@qq.com

研究负责人电子邮件：

Study leader's E-mail：

icyf1968@163.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：

上海市虹口区甘河路110号

研究负责人通讯地址：

上海市虹口区甘河路110号

Applicant address：

110 Ganhe Road, Hongkou District, Shanghai

Study leader's address：

110 Ganhe Road, Hongkou District, Shanghai

申请注册联系人邮政编码：

Applicant postcode：

200080

研究负责人邮政编码：

Study leader's postcode：

200080

申请人所在单位：

上海中医药大学附属岳阳中西医结合医院

Applicant's institution：

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine

研究负责人所在单位：

上海中医药大学附属岳阳中西医结合医院

Affiliation of the Leader：

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

2023-048

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：

上海中医药大学附属岳阳中西医结合医院伦理委员会

Name of the ethic committee：

Ethics Committee of Yueyang Integrated Traditional Chinese and Western Medicine Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

2023-07-20 00:00:00

伦理委员会联系人：

殷从全

Contact Name of the ethic committee：

YinCongquan

伦理委员会联系地址：

上海市虹口区甘河路110号

Contact Address of the ethic committee：

110 Ganhe Road, Hongkou District, Shanghai

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 21 6516 1782

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：

上海中医药大学附属岳阳中西医结合医院

Primary sponsor：

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine

研究实施负责（组长）单位地址：

上海市虹口区甘河路110号

Primary sponsor's address：

110 Ganhe Road, Hongkou District, Shanghai

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)：

上海中医药大学附属岳阳中西医结合医院

具体地址：

上海市虹口区甘河路110号

Institution
hospital：

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine

Address：

110 Ganhe Road, Hongkou District, Shanghai

经费或物资来源：

国家自然科学基金项目（81904300） 上海市科学委员会项目（21ZR1464300）

Source(s) of funding：

National Natural Science Foundation Project (81904300) Shanghai Municipal Committee of Science Project (21ZR1464300)

Target disease：

Breast cancer, insomnia

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 I期临床试验 

Study phase：

1

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

1.临床研究：通过单中心、单盲、随机、对照的临床研究，以“俞募配穴”为配穴方法，观察针刺对阴虚火旺型乳腺癌术后患者失眠临床疗效，并以量表作为主观评价指标，睡眠监测（polysomnography ,PSG）作为客观评价指标（符合标准的部分受试者），观察俞募配穴法针刺对乳腺癌术后患者失眠患者的睡眠质量和疲劳、生活质量等癌症相关症状的改善情况，并分析与失眠改善情况的相关性并评价其安全性，由此进一步深化“俞募配穴”理论的古代内涵，阐释其与当今针灸临床的密切关系，形成针灸治疗失眠更加简便、优化的方案。 2.机制探讨：以阴虚火旺型乳腺癌术后患者失眠患者为研究对象，通过与相匹配的健康受试者对比，运用多功能磁共振的分析方法，探讨阴虚火旺型乳腺癌术后患者失眠患者的脑区异常区域、脑区异常连接状态。 以阴虚火旺型乳腺癌术后患者失眠患者研究对象，通过“俞募配穴”针刺组内治疗前后比较以及与安慰针组治疗后比较，运用多功能磁共振的分析方法，筛选组内和组间差异性脑区及脑功能连接状态，探讨“俞募配穴”针刺治疗乳腺癌术后患者失眠的脑效应机制。 通过进一步统计分析该类失眠患者差异脑区及连接状态与失眠严重程度、焦虑状态、抑郁状态及中医证候状态的关系，进一步深化中枢机制与临床的联系性。  

Objectives of Study：

1. Clinical research: through a single center, single blind, randomized and controlled clinical study, the clinical efficacy of acupuncture on insomnia in postoperative patients with breast cancer of yin deficiency and fire hyperactivity type was observed with the method of "shu mu point matching", and the scale was used as the subjective evaluation index, and the polysomnography (PSG) was used as the objective evaluation index (some subjects meeting the standard), To observe the improvement of sleep quality, fatigue, quality of life and other cancer related symptoms of patients with insomnia after breast cancer surgery by acupuncture at the combination of Shu and Mu points, analyze the correlation with the improvement of insomnia and evaluate its safety, so as to further deepen the ancient connotation of the theory of "combination of Shu and Mu points", explain its close relationship with today's acupuncture and moxibustion clinic, and form a more simple and optimized scheme of acupuncture and moxibustion for insomnia treatment. 2. Mechanism discussion: Taking the patients with insomnia after breast cancer surgery of yin deficiency and fire excess type as the research object, by comparing with the matched healthy subjects, and using the analysis method of multi-functional magnetic resonance, to explore the abnormal regions and abnormal connectivity of brain regions in patients with insomnia after breast cancer surgery of yin deficiency and fire excess type. With the research object of insomnia patients in breast cancer patients after operation of yin deficiency and fire hyperactivity type, through the comparison before and after treatment in the acupuncture group of "Shu Mu point combination" and the comparison after treatment with the comfort acupuncture group, the analysis method of multi-functional magnetic resonance was used to screen the different brain regions and brain functional connectivity within and between groups, and explore the brain effect mechanism of "Shu Mu point combination" acupuncture in the treatment of insomnia in breast cancer patients after operation. By further statistical analysis of the relationship between the different brain regions and connectivity status of this type of insomnia patient and the severity of insomnia, anxiety state, depression state, and traditional Chinese medicine syndrome state, we will further deepen the connection between central mechanism and clinical practice.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1.阴虚火旺型乳腺癌术后患者失眠的纳入标准 （1）年龄≥18岁且≤75岁的女性； （2）诊断为原发性乳腺恶性肿瘤的患者，临床分期为I-III期； （3）入组前已完成相应的放疗、化疗或手术治疗至少3个月，内分泌靶向治疗除外。 （4）符合ICSD-3中慢性失眠的诊断标准； （5）术后1周内始出现失眠症状； （6）中医辨证分型为阴虚火旺型； （7）ISI＞7分（有临床意义的失眠）； （8）允许服用安眠相关药物（巴比妥类、水合氯醛、三溴合剂和羟嗪、苯二氮卓类镇静催眠药、唑吡坦、扎来普隆、佐匹克隆），未经同意参与者在研究期间不可擅自增加剂量或更换药物，在整个研究过程中，对需对药物和助眠剂进行调整，需要告知研究者做详细记录； （9）自愿参加本次课题，并签署知情同意书。 2.多功能磁共振（fMRI）扫描受试者纳入标准 （1）符合4.1中所有标准，即符合阴虚火旺型乳腺癌术后失眠患者纳入标准； （2）右利手； （3）无脑部器质性病变； （4）不具有磁共振检查禁忌症（如金属植入物、幽闭恐怖症者等）。 （5）进入本研究前3个月内未服用镇静催眠类药物，且在治疗和随访期间不能自行服用类似药物及保健品； （6）自愿进行共计2次多功能磁共振扫描，并签署知情同意书。 3.健康受试者的纳入标准 （1）年龄在≥18岁且≤75岁的女性； （2）经诊断排除患有肿瘤以及肿瘤相关并发症； （3）右利手； （4）无各系统功能障碍； （5）无脑部器质性病变； （6）无基础疾病； （7）无吸烟饮酒、特殊睡眠及饮食等不良习惯； （8）不具有磁共振检查禁忌症（如金属植入物、幽闭恐怖症者等）； （9）ISI≤7分（没有临床意义的失眠）； （10）自愿进行共计1次多功能磁共振扫描，并签署知情同意书。

Inclusion criteria

1. Inclusion criteria for insomnia in breast cancer patients with yin deficiency and fire hyperactivity (1) Women aged ≥ 18 years and ≤ 75 years; (2) Patients diagnosed with primary breast malignant tumors have a clinical stage of I-III; (3) Prior to enrollment, corresponding radiotherapy, chemotherapy, or surgical treatment has been completed for at least 3 months, except for endocrine targeted therapy. (4) Meets the diagnostic criteria for chronic insomnia in ICSD-3; (5) Insomnia symptoms begin to appear within one week after surgery; (6) The traditional Chinese medicine syndrome differentiation is divided into yin deficiency and excessive fire type; (7) ISI>7 points (clinically significant insomnia); (8) It is allowed to take sleeping related drugs (barbiturates, chloral hydrate, tribromine mixture and hydroxyzine, benzodiazepine sedative and hypnotic drugs, zolpidem, zaleplon, zopiclone), and participants are not allowed to increase or change medication without consent during the study period. Throughout the entire study process, adjustments to medication and sleeping aids need to be notified to the researchers for detailed records; (9) Volunteer to participate in this project and sign an informed consent form. 2. Inclusion criteria for subjects undergoing multifunctional magnetic resonance imaging (fMRI) scanning (1) Meet all the criteria in 4.1, that is, meet the inclusion criteria for insomnia patients after breast cancer surgery with yin deficiency and fire hyperactivity; (2) Right-handed; (3) No organic brain lesions; (4) No contraindications for magnetic resonance imaging (such as metal implants, claustrophobia, etc.). (5) Within the first 3 months of entering this study, no sedative or hypnotic drugs were taken, and similar drugs and health products cannot be taken on their own during treatment and follow-up; (6) Volunteer to conduct a total of 2 multi-functional magnetic resonance scans and sign an informed consent form. 3. Inclusion criteria for healthy subjects (1) Women aged ≥ 18 and ≤ 75 years old; (2) Diagnosed and ruled out having tumors and tumor related complications; (3) Right-handed; (4) No system dysfunction; (5) No organic brain lesions; (6) No underlying diseases; (7) No bad habits such as smoking, drinking, special sleep, and eating; (8) No contraindications for magnetic resonance imaging (such as metal implants, claustrophobia, etc.); (9) ISI ≤ 7 points (insomnia without clinical significance); (10) Voluntarily conduct a total of 1 multi-functional magnetic resonance imaging scan and sign an informed consent form.

排除标准：

1.乳腺癌术后失眠患者排除标准 （1）合并其他肿瘤； （2）严重的心、肝、肾以及血液、呼吸系统等疾病； （3）根据《精神障碍诊断与统计手册》诊断为精神疾病患者； （4）其他类型的睡眠障碍，如睡眠呼吸暂停、不宁腿综合征 （PSG显示睡眠呼吸暂停低通气≥10/h或PSG显示睡眠周期性肢体运动＞15次/h）；倒班工作者睡眠障碍等； （5）妊娠期或哺乳期妇女； （6）传染性疾病； （7）乳房皮肤破溃至无法接受针灸治疗者； （8）畏针、晕针者； （9）在最近3个月内参与过其他课题； （10）严重的视觉、听觉或语言缺陷；酗酒或滥用药物者等不良生活习惯者； 2.健康受试者排除标准 （1）根据《精神障碍诊断与统计手册》诊断为精神疾病患者； （2）妊娠期或哺乳期妇女； （3）传染性疾病患者； （4）严重的视觉、听觉或语言缺陷；酗酒或滥用药物者等不良生活习惯者； （5）其他类型的睡眠障碍，如睡眠呼吸暂停、不宁腿综合征、倒班工作者睡眠障碍等； （6）情绪不良、不配合者。 (7) 在最近3个月内参与过其他课题。

Exclusion criteria：

1. Exclusion criteria for insomnia patients after breast cancer surgery (1) Merge with other tumors; (2) Severe heart, liver, kidney, blood, respiratory system and other diseases; (3) Diagnosed as a mental illness patient according to the "Manual for Diagnosis and Statistics of Mental Disorders"; (4) Other types of sleep disorders, such as sleep apnea and restless legs syndrome (PSG shows sleep apnea hypopnea ≥ 10/h or PSG shows periodic limb movements>15 times/h); Sleep disorders among shift workers; (5) Pregnant or lactating women; (6) Infectious diseases; (7) Those whose breast skin is broken to the point that they cannot accept acupuncture and moxibustion treatment; (8) Those who are afraid of needles or feel dizzy; (9) Participated in other projects within the past 3 months; (10) Severe visual, auditory, or language impairments; Individuals with unhealthy lifestyle habits such as alcohol or drug abuse; 2. Exclusion criteria for healthy subjects (1) Diagnosed as a mental illness patient according to the "Manual for Diagnosis and Statistics of Mental Disorders"; (2) Pregnant or lactating women; (3) Patients with infectious diseases; (4) Severe visual, auditory, or language impairments; Individuals with unhealthy lifestyle habits such as alcohol or drug abuse; (5) Other types of sleep disorders, such as sleep apnea, restless leg syndrome, and sleep disorders in shift workers; (6) Emotional disorders and lack of cooperation. (7) I have participated in other projects in the past 3 months.

研究实施时间：

Study execute time：

从 From 2023-07-20 00:00:00至 To 2024-07-19 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2023-07-20 00:00:00 至 To 2024-06-01 00:00:00  

干预措施：

Interventions：

组别：

针刺组

样本量：

41

Group：

Acupuncture group

Sample size：

干预措施：

针刺操作：患者采取仰卧位，75%医用酒精常规消毒后，用0.25×25mm 0.25×40mm（安迪，中国贵州）毫针进针。百会、印堂平刺0.5-0.8寸；安眠直刺1-1.5寸。以上穴位进针得气后平补平泻。心俞、肾俞、肝俞斜刺0.5-0.8寸。巨阙向上斜刺0.5-1寸，不可深刺，京门直刺0.5-1寸。期门斜刺0.5-0.8寸，心俞、肝俞、巨阙、期门进针后采用行针法，使患者得气，至局部酸麻重胀为度，而后采用捻转补泻手法中的泻法，即捻转角度大，用力重，频率快，操作时间长，结合拇指向后用力重、向前用力轻的操作手法；同时采用轻插重提的操作手法。肾俞、京门采用捻转补泻手法中的补法，即捻转角度小，用力轻，频率慢，操作时间短，结合拇指向前用力重、向后用力轻的操作手法；同时采用重插轻提的操作手法。所有穴位均留针20分钟。 5名有3-10年经验的针灸师提供了干预措施，研究开始前接受了相关的治疗方案的培训。 疗程：每周治疗2次（每周一、五各治疗一次），连续治疗10次。

干预措施代码：

Intervention：

Acupuncture operation: The patient is placed in a supine position, and after routine disinfection with 75% medical alcohol, 0.25 is used × 25mm 0.25 × 40mm (Andy, Guizhou, China) millineedle injection. Baihui and Yintang flat thorns, 0.5 to 0.8 inches; Sleeping Stab 1-1.5 inches. After receiving acupuncture at the above acupoints, the qi is replenished and reduced. Heart Shu, Kidney Shu, and Liver Shu oblique needling 0.5 to 0.8 inches. The Tu Xing is tilted upwards by 0.5 to 1 inch, and cannot be pierced deeply. The Jingmen is stabbed directly by 0.5 to 1 inch. The oblique needling of the Qi Gate is 0.5 to 0.8 inches. After inserting the needles into the Heart Shu, Liver Shu, Tu Que, and Qi Gate, the acupuncture method is used to make the patient gain qi until the local soreness and numbness become severe. Then, the reduction method in the Twisting and Replenishing Reduction Technique is used, which is a large angle, heavy force, fast frequency, and long operation time, combined with the thumb's backward force, light force forward operation technique; At the same time, the operation technique of light insertion and heavy lifting is adopted. Shenshu and Jingmen adopt the tonifying method of the twisting and tonifying reduction technique, which is characterized by small twisting angle, light force, slow frequency, short operation time, and a combination of thumb forward force with heavy force and backward force with light force; At the same time, the operation technique of heavy insertion and light lifting is adopted. All acupuncture points are left with needles for 20 minutes. Five acupuncture and moxibustion with 3-10 years of experience provided intervention measures and received training on relevant treatment schemes before the study began. Course of treatment: Treat twice a week (once a week on Mondays and Fridays), and continuously treat 10 times.

Intervention code：

组别：

对照组

样本量：

41

Group：

control group

Sample size：

干预措施：

对照组采用假针刺法。 使用Streitberger安慰剂针，一种钝针尖的非侵入性安慰剂对照。该设备是目前被广泛报道且认可的假针刺手段。 针刺操作：患者采取仰卧位，“假穴”选穴为治疗组所选穴位旁开0.5寸，避开真穴所属经脉，75%医用酒精常规消毒后，用假针装置进针。通过覆盖着塑料片的塑料环将针与针刺部位固定,针的尖端圆钝,针柄与针体接触部位不固定,当针头接触皮肤时会产生疼痛,而针身会退回针柄内,给人以针刺入人体的错觉但并不会刺入皮肤内,以达到安慰针刺的效果。针头也将保留20分钟，然后再取出。 疗程：每周治疗次（每周一、五各治疗一次），连续治疗10次。

干预措施代码：

Intervention：

The control group was treated with sham acupuncture. Using Streitberger placebo needles, a non-invasive placebo control with blunt needle tips. This device is currently widely reported and recognized as a pseudo acupuncture method. Acupuncture operation: The patient is placed in a supine position, and the "fake acupoint" is selected by opening 0.5 inches next to the selected acupoint in the treatment group, avoiding the meridians to which the real acupoint belongs. After routine disinfection with 75% medical alcohol, the needle is inserted using a fake needle device. The needle is fixed to the needle site through a plastic ring covered with plastic sheets. The tip of the needle is blunt, and the contact area between the needle handle and the needle body is not fixed. When the needle head contacts the skin, it will cause pain, and the needle body will retract into the needle handle, giving the illusion of needle penetration into the human body but not into the skin, in order to comfort the needle. The needle will also be retained for 20 minutes before removal. Course of treatment: Treat once a week (once a week on Mondays and Fridays respectively), continuously treating 10 times.

Intervention code：

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)：

上海中医药大学附属岳阳中西医结合医院 

单位级别：

三甲 

Institution
hospital：

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

失眠严重指数

指标类型：

主要指标

Outcome：

ISI

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

匹兹堡睡眠质量指数

指标类型：

次要指标

Outcome：

Pittsburgh Sleep Quality Index,PSQI

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

多导睡眠监测

指标类型：

次要指标

Outcome：

polysomnography,PSG

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

睡眠日记

指标类型：

次要指标

Outcome：

Sleep Diary

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

贝克焦虑量表

指标类型：

次要指标

Outcome：

Beck Anxiety Inventory,BAI

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

贝克抑郁量表

指标类型：

次要指标

Outcome：

Beck Depression Inventory-II,BDI-II

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

简短疲劳量表

指标类型：

次要指标

Outcome：

fatigue score measured by the Chinese version of the Brief Fatigue Inventory,BFI-C

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

乳腺癌治疗功能评估

指标类型：

次要指标

Outcome：

Functional Assessment of Cancer Therapy-Breast ,FACT-B

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

中医证候量表

指标类型：

次要指标

Outcome：

Traditional Chinese Medicine Syndrome 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：

癌胚抗原

指标类型：

次要指标

Outcome：

CEA

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

雌激素

指标类型：

次要指标

Outcome：

estrogen

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：

征募研究对象情况：

Recruiting status：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 75 岁 years

性别：

女性

Gender：

Female

随机方法（请说明由何人用什么方法产生随机序列）：

研究人员依据由SPSS 26.0版统计软件产生的随机数字法，随机分配到针刺组或对照组。

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

Researchers were randomly assigned to the acupuncture group or control group based on the random number method generated by SPSS version 26.0 statistical software.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

试验过程中，随机数字表的产生、受试者的招募、随机方案的分配、睡眠量表的评估和治疗后的随访分别由不同的研究人员独立完成。整个试验中，仅针灸医师和分配随机方案的研究者对分组知情，对结局评估者及数据分析者均设盲。

Blinding：

During the experiment, the generation of a random number table, recruitment of subjects, allocation of random protocols, evaluation of sleep scales, and follow-up after treatment were independently completed by different researchers. In the whole experiment, only acupuncture and moxibustion physicians and researchers assigned with randomized schemes were informed of the grouping, and the outcome evaluators and data analysts were blinded.

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

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）：

临床试验公共管理平台 IPD（http://www.medresman.org.cn）。2024年12月之后联系项目申请者本人

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

ResMan IPD (http://www.medresman.org.cn) . Contact the project applicant after December 2024

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：

采用病历记录表进行数据采集

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

Using medical record forms for data collection

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2024-03-21 08:33:48