我要注册
立即登录
中文/English
平台介绍|试验检索|关于我们|新闻公告
“通督调神”针灸法治疗围绝经期睡眠障碍的临床疗效观察

注册号：

Registration number：

ITMCTR2025001146

最近更新日期：

Date of Last Refreshed on：

2025-06-10

注册时间：

Date of Registration：

2025-06-10

注册号状态：

Registration Status：

补注册

Retrospective registration

注册题目：

“通督调神”针灸法治疗围绝经期睡眠障碍的临床疗效观察

Public title：

Effect of Tongdu Tiaoshen Acupuncture on Perimenopausal Sleep Disorders: A Clinical Study

注册题目简写：

English Acronym：

研究课题的正式科学名称：

“通督调神”针灸法治疗围绝经期睡眠障碍的临床疗效观察

Scientific title：

Effect of Tongdu Tiaoshen Acupuncture on Perimenopausal Sleep Disorders: A Clinical Study

研究课题的正式科学名称简写：

“通督调神”针灸法治疗围绝经期睡眠障碍

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：

申请注册联系人：

许宏

研究负责人：

尹婷

Applicant：

xuhong

Study leader：

yinting

申请注册联系人电话：

Applicant telephone：

18689571907

研究负责人电话：

Study leader's telephone：

18038828900

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：

hongxu1004@qq.com

研究负责人电子邮件：

Study leader's E-mail：

46361702@qq.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：

广东省佛山市广东省中西医结合医院

研究负责人通讯地址：

广东省佛山市广东省中西医结合医院

Applicant address：

Guangdong Provincial Hospital of Integrated Traditional Chinese and Western Medicine Foshan Guangdong PR Chin

Study leader's address：

Guangdong Provincial Hospital of Integrated Traditional Chinese and Western Medicine Foshan Guangdong PR Chin

申请注册联系人邮政编码：

Applicant postcode：

528200

研究负责人邮政编码：

Study leader's postcode：

528200

申请人所在单位：

广东省中西医结合医院

Applicant's institution：

Guangdong Provincial Hospital of Integrated Traditional Chinese and Western Medicine

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：

2023-105

伦理委员会批件附件：

Approved file of Ethical Committee：

查看附件

批准本研究的伦理委员会名称：

广东省中西医结合医院伦理委员会

Name of the ethic committee：

Ethics Committee of Guangdong Provincial Hospital of Integrated Traditional Chinese and Western Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

2023/11/6 0:00:00

伦理委员会联系人：

任晓玲

Contact Name of the ethic committee：

xiaoling ren

伦理委员会联系地址：

广东省佛山市广东省中西医结合医院

Contact Address of the ethic committee：

Guangdong Provincial Hospital of Integrated Traditional Chinese and Western Medicine Foshan Guangdong PR Chin

伦理委员会联系人电话：

Contact phone of the ethic committee：

0757-86207629

伦理委员会联系人邮箱：

Contact email of the ethic committee：

gdzxyscience@163.com

研究实施负责（组长）单位：

广东省中西医结合医院

Primary sponsor：

Guangdong Provincial Hospital of Integrated Traditional Chinese and Western Medicine

研究实施负责（组长）单位地址：

广东省佛山市广东省中西医结合医院

Primary sponsor's address：

Guangdong Provincial Hospital of Integrated Traditional Chinese and Western Medicine Foshan Guangdong PR Chin

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

市(区县)：

佛山

Country：

China

Province：

Guangdong

City：

Foshan

单位(医院)：

广东省中西医结合医院

具体地址：

广东省佛山市南海区桂城街道南五路16号广东省中西医结合医院

Institution
hospital：

Guangdong Provincial Hospital of Integrated Traditional Chinese and Western Medicine

Address：

Guangdong Provincial Hospital of Integrated Traditional Chinese and Western MedicineNo.16 Nanwu Road Guicheng Street Nanhai District Foshan City Guangdong Province

经费或物资来源：

自筹

Source(s) of funding：

raise independently

研究疾病：

围绝经期睡眠障碍

研究疾病代码：

Target disease：

Perimenopausal Sleep Disorders

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：

围绝经期是女性生命中的重要转折时期。有研究表明，现全球每年约有 150 万女性进入围绝经期，且在围绝经期的众多伴随症状中，精神神经系统的症状最为常见,平均发生率为 75.2%,尤以睡眠障碍最多见（67.75%）。随着老龄化社会的到来，将有一大部分女性进入围绝经期，这也意味着围绝经期睡眠障碍的疾患人群数将迎来新高峰。西医药物对围绝经期睡眠障碍的治疗有一定的疗效，但因其存在诱发心血管疾病、诱发癌症等风险，并可产生成瘾性及戒断反应，因此限制了其有效广泛地使用。那么，寻找一种相对安全、可靠的治疗方案急不可待。中医药依靠其毒副作用少、临床疗效显著、多模式治疗等特点正逐渐被运用于临床中。而针灸作为我国的文化瑰宝，一直在中医中扮演着不可或缺的角色。由于针灸的无毒副作用、患者接受度高、操作方便等优势，所以在治疗睡眠障碍上有着巨大的发展前景。本研究基于“通督调神” 的理论，结合本研究团队数十年的临床经验，根据“病变在脑，首取督脉”治疗围绝经期睡眠障碍妇女，可疏通督脉及其相络属各经络系统，同时运转神机，使得气血运行通畅，经络、脏腑得以充养。目前该学术思想已经广泛运用于慢性疾病的治疗。同时，与常规针刺及西药口服相比较，本项目通过观察“通督调神”针灸法治疗围绝经期睡眠障碍患者的临床疗效，评估“通督调神”针灸法临床的可行性、有效性、优势性及科学性，初步阐述“通督调神”针灸法治疗围绝经期睡眠障碍患者的作用机制，从而更好地将该技术在市内外进行推广应用。

Objectives of Study：

Perimenopausal period is an important turning point in women's lives. Studies have shown that approximately 1.5 million women worldwide enter perimenopause each year and among the many accompanying symptoms of perimenopause symptoms of the nervous system are the most common with an average incidence rate of 75.2% particularly sleep disorders (67.75%). With the arrival of an aging society a large proportion of women will enter perimenopause which also means that the number of people with sleep disorders during perimenopause will reach a new peak. Western medicine drugs have certain therapeutic effects on sleep disorders during perimenopause but their effective and widespread use is limited due to the risk of inducing cardiovascular disease cancer addiction and withdrawal reactions. So it is urgent to find a relatively safe and reliable treatment plan. Traditional Chinese medicine is gradually being applied in clinical practice due to its characteristics of minimal toxic side effects significant clinical efficacy and multimodal treatment. As the cultural treasure of China acupuncture and moxibustion has always played an indispensable role in traditional Chinese medicine. Because of the advantages of acupuncture and moxibustion such as non-toxic side effects high patient acceptance and convenient operation it has a huge development prospect in the treatment of sleep disorders. This study is based on the theory of "regulating the meridians and regulating the spirit" combined with decades of clinical experience of our research team. According to the treatment of perimenopausal sleep disorders in women with "lesions in the brain the first to take the Du meridian" the Du meridian and its related meridian systems can be unblocked and at the same time the divine mechanism can be operated making the qi and blood flow unobstructed and the meridians and organs can be nourished. At present this academic idea has been widely applied in the treatment of chronic diseases. At the same time compared with conventional acupuncture and oral administration of western medicine this project assesses the clinical feasibility effectiveness superiority and scientificity of "Tongdu Tiaoshen" acupuncture and moxibustion method by observing the clinical efficacy of "Tongdu Tiaoshen" acupuncture and moxibustion method in the treatment of perimenopausal sleep disorder patients and initially expounds the mechanism of "Tongdu Tiaoshen" acupuncture and moxibustion method in the treatment of perimenopausal sleep disorder patients so as to better promote and apply this technology inside and outside the city.

药物成份或治疗方案详述：

1.“通督调神”针灸组（观察组） （1）取穴：针刺：百会，印堂，大椎，至阳，命门，腰阳关，心俞，胆俞；麦粒灸：内关，三阴交，关元，中脘。 （2）针具及器材：选用苏州针灸用品有限公司生产的“环球”牌针灸针，规格为：0.22×40mm，即长 1.5 寸，直径 0.22 mm。 （3）操作方法：患者取俯卧位，穴位常规消毒。百会、印堂平刺，其余穴位直刺。针刺深度依据患者体型及穴位可刺深度而定，得气后嘱患者闭眼休息，留针30 分钟。出针后，取仰卧位，在内关、三阴交、关元、中脘穴位表面涂少量万花油，放置麦粒大小艾炷，以线香点燃，当患者感到灼痛时去掉艾炷，每穴灸５壮，灸毕涂万花油。 （4）疗程：针刺及麦粒灸每周 5 次，连续治疗 2 周（14 天）。 2.常规针刺组（对照组 1） （1）取穴：百会、四神聪、申脉（双）、照海（双）、神门（双）、三阴交（双）、安眠（双） （2）针具及器材：选用苏州针灸用品有限公司生产的“环球”牌针灸针，规格为：0.22×40mm，即长 1.5 寸，直径 0.22 mm。 （3）操作方法： 患者取仰卧位，穴位常规消毒。百会、四神聪穴平刺，其余穴位直刺，得气后留针 30 分钟。 （4）疗程：每周治疗 5 次，连续治疗 2 周（14 天）。 3.药物治疗组（对照组 2）给予阿普唑仑片（北京市燕京药业有限公司，批准文号：国药准字H11020429）0.4mg 口服，每日 1 次，睡前 30min 服用。结合睡眠情况的改变，适当增减药量，服药 2 周（14 天）后收集相关数据观察疗效。服药期间密切关注患者情况

Description for medicine or protocol of treatment in detail：

1. "Tongdu Tiaoshen" acupuncture and moxibustion group (observation group) (1) Acupoint selection: Acupuncture: Baihui Yintang Dazhui Zhiyang Mingmen Yaoyang Pass Xinyu Danyu; Wheat grain moxibustion: Neiguan Sanyinjiao Guanyuan Zhongwan. (2) Needles and equipment: "Huanqiu" brand acupuncture and moxibustion needles produced by Suzhou acupuncture and moxibustion Supplies Co. Ltd. are selected with the specification of 0.22 × 40mm that is 1.5 inches in length and 0.22mm in diameter. (3) Operation method: The patient is placed in a prone position and the acupoints are disinfected regularly. Baihui and Yintang are pricked flat while other acupoints are directly pricked. The depth of acupuncture depends on the patient's body shape and the depth of the acupoint that can be penetrated. After obtaining qi instruct the patient to close their eyes and rest and leave the needle for 30 minutes. After the needle is inserted take a supine position and apply a small amount of Wan Hua oil on the surface of the Neiguan Sanyinjiao Guanyuan and Zhongwan acupoints. Place a wheat sized moxa stick and light it with incense. When the patient feels burning pain remove the moxa stick and apply 5 strokes of Wan Hua oil to each acupoint. After the moxibustion apply Wan Hua oil. (4) Course of treatment: Acupuncture and moxibustion with wheat grains 5 times a week for 2 consecutive weeks (14 days). 2. Conventional acupuncture group (control group 1) (1) Acupoint selection: Baihui Sishen Cong Shenmai (double) Zhaohai (double) Shenmen (double) Sanyinjiao (double) Anping (double) (2) Needles and equipment: "Huanqiu" brand acupuncture and moxibustion needles produced by Suzhou acupuncture and moxibustion Supplies Co. Ltd. are selected with the specification of 0.22 × 40mm that is 1.5 inches in length and 0.22mm in diameter. (3) Operation method: The patient is placed in a supine position and the acupoints are disinfected routinely. Apply flat needling to Baihui and Sishen Cong acupoints and direct needling to other acupoints. Leave the needle on for 30 minutes after obtaining qi. (4) Course of treatment: Treat 5 times a week for 2 consecutive weeks (14 days). 3. The drug treatment group (control group 2) was given 0.4mg of alprazolam tablets (Beijing Yanjing Pharmaceutical Co. Ltd. approval number: National Medical Products Administration H11020429) orally once a day taken 30 minutes before bedtime. Based on changes in sleep conditions adjust the dosage appropriately and collect relevant data after 2 weeks (14 days) of medication to observe the therapeutic effect. Pay close attention to the patient's condition during medication

纳入标准：

纳入标准 （1）女性患者，45 岁≤年龄≤60 岁； （2）符合围绝经期睡眠障碍中西医诊断标准者； （3）匹兹堡睡眠质量指数（PSQI）评分≥7 分者； （4）入组前 1 个月内未接受其他治疗者； （5）患者本人及家属自愿参加本项研究，并签署知情同意书。

Inclusion criteria

Inclusion Criteria (1) Female patients aged 45 to 60 years old; (2) Those who meet the diagnostic criteria of traditional Chinese and Western medicine for sleep disorders during perimenopause; (3) Pittsburgh Sleep Quality Index (PSQI) score ≥ 7; (4) Individuals who have not received any other treatment within one month prior to enrollment; (5) The patient and their family voluntarily participate in this study and sign an informed consent form.

排除标准：

排除标准 （1）有严重药物过敏或其他原因不适合针刺治疗者； （2）合并有抑郁症、焦虑症、精神分裂症等严重精神疾病患者； （3）有因躯体疾病、精神疾病、滥用药物等其他原因所引起的睡眠障碍患者； （4）合并心脑血管、肝肾功能、造血系统等严重疾病者； （5）双侧卵巢切除、卵巢器质性病变、卵巢功能早衰者。

Exclusion criteria：

exclusion criteria (1) Individuals with severe drug allergies or other reasons who are not suitable for acupuncture treatment; (2) Patients with severe mental illnesses such as depression anxiety and schizophrenia are included; (3) Patients with sleep disorders caused by physical illnesses mental illnesses drug abuse and other reasons; (4) Patients with severe diseases such as cardiovascular and cerebrovascular diseases liver and kidney function and hematopoietic system; (5) Bilateral oophorectomy ovarian organic lesions and premature ovarian failure.

研究实施时间：

Study execute time：

从From 2023-11-07

至To      2024-10-31

征募观察对象时间：

Recruiting time：

从From 2023-11-07

至To      2024-03-31

干预措施：

Interventions：

组别：

药物治疗组

样本量：

30

Group：

The drug treatment group

Sample size：

干预措施：

阿普唑仑片

干预措施代码：

Intervention：

alprazolam tablets

Intervention code：

组别：

“通督调神”针灸组

样本量：

30

Group：

"Tongdu Tiaoshen" acupuncture and moxibustion group

Sample size：

干预措施：

针灸和麦粒灸

干预措施代码：

Intervention：

"Tongdu Tiaoshen" acupuncture and Wheat grain moxibustion

Intervention code：

组别：

常规针刺组

样本量：

30

Group：

Conventional acupuncture group

Sample size：

干预措施：

常规针灸

干预措施代码：

Intervention：

Conventional acupuncture

Intervention code：

样本总量 Total sample size ： 90

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

广东

市(区县)：

佛山

Country：

China

Province：

Guangdong

City：

Foshan

单位(医院)：

广东省中西医结合医院

单位级别：

三级甲等医院

Institution/hospital：

Guangdong Provincial Hospital of Integrated Traditional Chinese and Western Medicine

Level of the institution：

Class A tertiary hospital

测量指标：

Outcomes：

指标中文名：

匹兹堡睡眠质量指数量表

指标类型：

主要指标

Outcome：

pittsburgh sleep quality index

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

改良的 Kupperman 量表评

指标类型：

次要指标

Outcome：

Improved Kuperman Scale Evaluation

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：

无

组织：

Sample Name：

not have

Tissue：

人体标本去向

其它

说明

Fate of sample 

Others

Note：

征募研究对象情况：

结束

Completed

年龄范围：

最小 45 岁
Min age years
最大 60 岁
Max age years

Recruiting status：

Participant age：

性别：

Gender：

女性

Female

随机方法（请说明由何人用什么方法产生随机序列）：

拟收90 例围绝经期睡眠障碍患者，研究人员根据各自入组时间的顺序进行编号，查随机数字表，按随机分配原则分为“通督调神”针灸组（观察组）、常规针刺组（对照组1）和药物组（对照组 2），每组各 30 例。

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

90 patients with perimenopausal sleep disorder are proposed to be enrolled. The researchers numbered them according to the order of their admission time and checked the random number table. According to the principle of random allocation they were divided into "Tongdu Tiaoshen" acupuncture and moxibustion group (observation group) conventional acupuncture group (control group 1) and drug group (control group 2) with 30 cases in each group.

盲法：

Blinding：

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）：

无

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

not have

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：

通过病例报告表进行数据采集，采用excel进行数据管理。

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

Collect data through case report forms and manage data using Excel.

数据管理委员会：

Data Managemen Committee：

有

Yes

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):

返回
平台信息
平台简介
关于我们
试验注册
常见问题
伦理审查
公共服务
试验检索
参与我们
国际传统医学临床试验注册平台 京ICP备07032215号-5 提示：推荐使用IE8.0以上版本 宽屏显示分辨率下使用系统