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Clinical randomized controlled trial of acupuncture for functional constipation based on the theory of “interior-exterior relationship between the lung and the large Intestine”

注册号：

Registration number：

ITMCTR2024000312

最近更新日期：

Date of Last Refreshed on：

2024-08-27

注册时间：

Date of Registration：

2024-08-27

注册号状态：

Registration Status：

补注册

Retrospective registration

注册题目：

基于“肺与大肠相表里”针刺治疗功能性便秘的临床随机对照试验

Public title：

Clinical randomized controlled trial of acupuncture for functional constipation based on the theory of “interior-exterior relationship between the lung and the large Intestine”

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于“肺与大肠相表里”针刺治疗功能性便秘的临床随机对照试验

Scientific title：

Clinical randomized controlled trial of acupuncture for functional constipation based on the theory of “interior-exterior relationship between the lung and the large Intestine”

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：

申请注册联系人：

严雪儿

研究负责人：

谭程

Applicant：

YanXE

Study leader：

TanC

申请注册联系人电话：

Applicant telephone：

18801040063

研究负责人电话：

Study leader's telephone：

13488782477

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：

unnyyan@163.com

研究负责人电子邮件：

Study leader's E-mail：

tancheng206@126.com

申请单位网址(自愿提供)：

Study leader's website(voluntary supply)：

https://www.dzmyy.com.cn/

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：

北京市朝阳区北三环东路11号

研究负责人通讯地址：

北京市东城区海运仓5号

Applicant address：

No. 11, Bei San Huan Dong Lu, Chaoyang District, Beijing100029

Study leader's address：

Dongcheng District, Hai Yun Cang on the 5th Zip

申请注册联系人邮政编码：

Applicant postcode：

100029

研究负责人邮政编码：

Study leader's postcode：

100700

申请人所在单位：

北京中医药大学东直门医院

Applicant's institution：

Dongzhimen Hospital of BeijingUniversity of Chinese 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：

2024DZMEC-187-02

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：

北京中医药大学东直门医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Dongzhimen Hospital of BeijingUniversity of Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

2024/6/18 0:00:00

伦理委员会联系人：

韩雪婷

Contact Name of the ethic committee：

HanXT

伦理委员会联系地址：

北京中医药大学东直门医院伦理办公室 H108房间

Contact Address of the ethic committee：

Ethics Office, Dongzhimen Hospital, Beijing University of Chinese Medicine, Room H108

伦理委员会联系人电话：

Contact phone of the ethic committee：

84012709

伦理委员会联系人邮箱：

Contact email of the ethic committee：

dzmyyec@126.com

研究实施负责（组长）单位：

北京中医药大学东直门医院

Primary sponsor：

Dongzhimen Hospital of BeijingUniversity of Chinese Medicine

研究实施负责（组长）单位地址：

北京市东城区海运仓5号

Primary sponsor's address：

Dongcheng District, Hai Yun Cang on the 5th Zip

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

市(区县)：

东城区

Country：

China

Province：

Beijing

City：

Dongcheng District

单位(医院)：

北京中医药大学东直门医院

具体地址：

北京市东城区海运仓5号

Institution
hospital：

Dongzhimen Hospital of BeijingUniversity of Chinese Medicine

Address：

Dongcheng District, Hai Yun Cang on the 5th Zip

经费或物资来源：

北京中医药大学东直门医院研究生课题经费

Source(s) of funding：

Funding for Postgraduate Projects at Dongzhimen Hospital of Beijing University of Chinese Medicine

研究疾病：

功能性便秘

研究疾病代码：

Target disease：

Functional constipation

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：

采用临床随机对照试验的方法验证“肺与大肠相表里”针刺治疗功能性便秘的疗效，旨在初步探讨通过“以肺治肠”针刺对于慢性功能性便秘患者便秘严重程度和生活质量的改善，以期为针灸治疗慢性功能性便秘提供新思路。

Objectives of Study：

In this study we used a randomised controlled trial to verify the efficacy of acupuncture in treating functional constipation based on the theory of 'interior-exterior relationship between the lung and the large Intestine in order to provide a new idea for the treatment of chronic functional constipation by acupuncture. The aim of this study is to provide new ideas for the treatment of chronic functional constipation with acupuncture.

药物成份或治疗方案详述：

采用随机（随机数字表法）、单盲（对受试对象设盲）、对照的设计将受试者随机分为2组：对照组（常规取穴组，取穴为天枢、上巨虚、支沟、照海）36例，试验组（即肺经穴组，取穴为天枢、上巨虚、支沟、照海、尺泽、列缺）36例。随机分配到两组的概率为各50%。两组均接受为期4周的针刺治疗，每周针刺3次，每次治疗每个穴位得气后留针20分钟。治疗期间允许使用110毫升甘油或40- 60毫升山梨醇肛门灌肠作为救援药物，并记录于便秘Wexner量表中。

Description for medicine or protocol of treatment in detail：

A randomised (random number table method) single-blind (blinding the subjects) controlled design was used to randomly divide the subjects into 2 groups: 36 cases in the control group (acupoints: ST25 ST37 SJ6 and KI6 leave the needle in place for 20 minutes after Deqi) and 36 cases in the experimental group (acupoints: ST25 ST37 SJ6 and KI6 LU5 and LU7 leave the needle in place for 20 minutes after Deqi.). The probability of random assignment to the two groups was 50% each. Both groups received a 4-week acupuncture treatment three times a week. The use of 110ml of glycerol or 40-60ml of sorbitol anal enema as rescue medication was allowed during the treatment period and recorded in the Wexner scale for constipation.

纳入标准：

1: 符合功能性便秘罗马Ⅳ诊断标准的患者； 2: 18岁≤年龄≤75岁，性别不限； 3: 入组前至少2周未服用便秘药物[除急救药物（包括甘油或山梨醇肛门灌肠）外]近2月未接受过便秘针灸治疗，并且在过去3个月内没有参加任何其他试验； 4: 受试者符合《中国慢性便秘专家共识意见（2019）》中重度FC的标准； 5: 受试者本人知情本研究内容，愿意配合并签署知情同意书。

Inclusion criteria

1.Patients meeting the Rome IV diagnostic criteria for functional constipation; 2. 18 years old ≤ age ≤ 75 years old, gender is not limited; 3. Subjects had not taken constipation medication [other than emergency medications (including glycerin or sorbitol anal enemas) for at least 2 weeks prior to group entry] had not been treated with constipation acupuncture in the last 2 months and had not been enrolled in any other trial in the last 3 months; 4. subjects met the criteria for severe FC in the Chinese Expert Consensus Opinion on Chronic Constipation (2019); 5. Subjects are personally informed of the contents of this study and are willing to cooperate and sign the informed consent form

排除标准：

1: 严重的心血管、肝脏或肾脏疾病； 2: 认知功能障碍、失语、精神障碍或可能影响患者合作的疾病; 3: 孕妇或哺乳期妇女; 4: 腹主动脉瘤或肝脾肿大，凝血障碍或常规使用抗凝剂，包括华法林或肝素(使用阿司匹林或氯吡格雷进行抗血小板治疗除外); 5: 心脏起搏器植入等不耐受针刺患者。

Exclusion criteria：

1. Serious cardiovascular, hepatic or renal disease 2. Cognitive dysfunction, aphasia, psychiatric disorders, or conditions that may affect the patient's cooperation; and 3. Pregnant or lactating women. 4. Patients with coagulation disorders such as abdominal aortic aneurysm, hepatosplenomegaly, or routine use of anticoagulants, including warfarin or heparin (except for antiplatelet therapy with aspirin or clopidogrel); 5. Patients who do not tolerate needling such as pacemaker implants.

研究实施时间：

Study execute time：

从From 2024-06-19

至To      2025-06-18

征募观察对象时间：

Recruiting time：

从From 2024-06-19

至To      2025-05-18

干预措施：

Interventions：

组别：

对照组（常规取穴组）

样本量：

36

Group：

Control group (routine acupoint taking group)

Sample size：

干预措施：

取穴双侧天枢、上巨虚、支沟、照海，每个穴位刺入得气后不实施补泻手法，留针20分钟。治疗期间允许使用110毫升甘油或40- 60毫升山梨醇肛门灌肠作为救援药物，并记录于便秘Wexner量表中。

干预措施代码：

Intervention：

Acupuncture points were taken bilaterally from S ST25 ST37 SJ6 and KI6, with no tonic or diarrhoeal manoeuvres implemented after each point was pricked to obtain qi, and the needles were left in place for 20 minutes. The use of 110 ml of glycerol or 40- 60 ml of sorbitol anal enema was allowed as rescue medication during the treatment period and was recorded in the Constipation Wexner Scale.

Intervention code：

组别：

试验组（肺经穴组）

样本量：

36

Group：

Test group (lung meridian point group)

Sample size：

干预措施：

取穴双侧天枢、上巨虚、支沟、照海、尺泽、列缺，每个穴位刺入得气后不实施补泻手法，留针20分钟。治疗期间允许使用110毫升甘油或40- 60毫升山梨醇肛门灌肠作为救援药物，并记录于便秘Wexner量表中。

干预措施代码：

Intervention：

Acupuncture points were taken bilaterally from ST25 ST37 SJ6 and KI6 LU5 and LU7, with no tonic or diarrhoeal manoeuvres implemented after each point was pricked to obtain qi, and the needles were left in place for 20 minutes. The use of 110 ml of glycerol or 40- 60 ml of sorbitol anal enema was allowed as rescue medication during the treatment period and was recorded in the Constipation Wexner Scale.

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)：

东城区

Country：

China

Province：

Beijing

City：

Dongcheng District

单位(医院)：

北京中医药大学东直门医院

单位级别：

三级甲等

Institution/hospital：

Dongzhimen Hospital of Beijing University of Chinese Medicine

Level of the institution：

Level 3A hospital

测量指标：

Outcomes：

指标中文名：

Wexner便秘评分

指标类型：

次要指标

Outcome：

Wexner Continence Grading Scale

Type：

Secondary indicator

测量时间点：

分别于入组前（基线）和治疗第1周后、2周后、3周后、4周后，针刺结束2周后进行评价

测量方法：

受试者填写量表，选择1周以内的情况进行填写。

Measure time point of outcome：

baseline, after the 1st, 2nd, 3rd, 4th week of treatment and 2 weeks after the end of treatment

Measure method：

Subjects completed the scale, selecting situations up to 1 week to complete.

指标中文名：

完全自主排便次数 ：指患者每周不需要通便药或手法, 自发的完全排尽感的大便次数。

指标类型：

主要指标

Outcome：

Complete Spontaneous Bowel Movements, (CSBMs)

Type：

Primary indicator

测量时间点：

分别于入组前（基线）和治疗第1周后、2周后、3周后、4周后，针刺结束2周后进行评价

测量方法：

受试者记录研究期间每周不需要通便药或手法, 自发的完全排尽感的大便次数。

Measure time point of outcome：

baseline, after the 1st, 2nd, 3rd, 4th week of treatment and 2 weeks after the end of treatment

Measure method：

Subjects recorded the number of bowel movements per week during the study period without the need for laxatives or maneuvers, with a spontaneous sense of complete evacuation.

指标中文名：

布里斯托大便性状评分

指标类型：

主要指标

Outcome：

Bristol Stool Scale

Type：

Primary indicator

测量时间点：

分别于入组前（基线）和治疗第1周后、2周后、3周后、4周后，针刺结束2周后进行评价

测量方法：

受试者记录每次排便性状，每次评价时选择出现次数最多的选项。布里斯托大便性状评分将大便分为Ⅰ型—Ⅶ型，每类别按1-7级评分，大便性状评分越高提示患者便秘程度越轻微。

Measure time point of outcome：

baseline, after the 1st, 2nd, 3rd, 4th week of treatment and 2 weeks after the end of treatment

Measure method：

Subjects recorded each bowel movement trait and chose the option with the highest number of occurrences at each evaluation. The Bristol Stool Trait Score categorizes stools into types I-VII, with each category rated on a scale of 1-7, with higher stool trait scores suggesting less constipation in patients.

指标中文名：

便秘患者生存质量自评量表

指标类型：

次要指标

Outcome：

Patient-Assessment of Constipation Quality Of Life （PAC-QOL)

Type：

Secondary indicator

测量时间点：

分别于入组前（基线）和治疗第1周后、2周后、3周后、4周后，针刺结束2周后进行评价

测量方法：

受试者填写量表，选择1周以内的情况进行填写。

Measure time point of outcome：

baseline, after the 1st, 2nd, 3rd, 4th week of treatment and 2 weeks after the end of treatment

Measure method：

Subjects completed the scale, selecting situations up to 1 week to complete.

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

研究不涉及采集人体标本，均为量表填写内容

组织：

Sample Name：

This study did not involve the collection of human specimens.

Tissue：

人体标本去向

其它

说明

Fate of sample 

Others

Note：

征募研究对象情况：

正在进行

Recruiting

年龄范围：

最小 18 岁
Min age years
最大 75 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）：

第三位研究者（非针刺研究者）使用随机数字表法产生随机数列。

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

A third researcher that without operating acupuncture used the random number table method to generate random number columns.

盲法：

对受试者隐藏分组，受试者们无法看到其他受试者的穴位；对评估者隐藏分组。

Blinding：

In this study the subjects were hidden from the group and the subjects were not able to see the acupoints of the other subjects; the assessors were hidden from the group.

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）：

-

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

-

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：

使用病例记录表(Case Record Form, CRF)采集原始信息，使用ResMan电子采集和管理系统(Electronic Data Capture, EDC)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：

Raw information was captured using a Case Record Form (CRF) and data was managed using the ResMan Electronic Data Capture and Management System (EDC).

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）：

预计于2025年8月前以论文形式公开发表研究结果，期刊暂未确定。

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

Public release of findings in the form of a paper is expected by August 2025, journal not yet determined.

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