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Study on the intervention of abdominal Huolong cupping with Nazi method on the patients with Qi-deficiency constipation after stroke

注册号：

Registration number：

ITMCTR2024000223

最近更新日期：

Date of Last Refreshed on：

2024-08-12

注册时间：

Date of Registration：

2024-08-12

注册号状态：

Registration Status：

补注册

Retrospective registration

注册题目：

纳子法腹部火龙罐对中风后气虚型便秘患者的干预研究

Public title：

Study on the intervention of abdominal Huolong cupping with Nazi method on the patients with Qi-deficiency constipation after stroke

注册题目简写：

English Acronym：

研究课题的正式科学名称：

纳子法腹部火龙罐对中风后气虚型便秘患者的干预研究

Scientific title：

Study on the intervention of abdominal Huolong cupping with Nazi method on the patients with Qi-deficiency constipation after stroke

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：

周佳佳

研究负责人：

周佳佳

Applicant：

ZhouJiajia

Study leader：

ZhouJiajia

申请注册联系人电话：

Applicant telephone：

15088084837

研究负责人电话：

Study leader's telephone：

15088084837

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：

905150718@qq.com

研究负责人电子邮件：

Study leader's E-mail：

905150718@qq.com

申请单位网址(自愿提供)：

Study leader's website(voluntary supply)：

广东省中医院

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：

广州市越秀区大德路111号

研究负责人通讯地址：

广州市越秀区大德路111号

Applicant address：

No.111, Dade Road, Yuexiu District, Guangzhou

Study leader's address：

No.111, Dade Road, Yuexiu District, Guangzhou

申请注册联系人邮政编码：

Applicant postcode：

510120

研究负责人邮政编码：

Study leader's postcode：

510120

申请人所在单位：

广东省中医院

Applicant's institution：

Guangdong Provincial Hospital 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：

BF2024-060*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：

广东省中医院伦理委员会

Name of the ethic committee：

Ethics Committee of Guangdong Hospital of Traditional Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

2024/3/28 0:00:00

伦理委员会联系人：

李晓彦

Contact Name of the ethic committee：

LiXiaoyan

伦理委员会联系地址：

广州市越秀区大德路111号

Contact Address of the ethic committee：

No.111, Dade Road, Yuexiu District, Guangzhou

伦理委员会联系人电话：

Contact phone of the ethic committee：

020-81887233转35943

伦理委员会联系人邮箱：

Contact email of the ethic committee：

905150718@qq.com

研究实施负责（组长）单位：

广东省中医院

Primary sponsor：

Guangdong Provincial Hospital of Chinese Medicine

研究实施负责（组长）单位地址：

广州市越秀区大德路111号

Primary sponsor's address：

No.111, Dade Road, Yuexiu District, Guangzhou

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)：

广州市

Country：

China

Province：

Guangdong Province

City：

Guangzhou city

单位(医院)：

广东省中医院

具体地址：

广州市越秀区大德路111号

Institution
hospital：

Guangdong Provincial Hospital of Chinese Medicine

Address：

No.111, Dade Road, Yuexiu District, Guangzhou

经费或物资来源：

广东省护士协会

Source(s) of funding：

Guangdong Nurses Association

研究疾病：

中风后便秘

研究疾病代码：

Target disease：

Poststroke 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：

治疗新技术临床试验

New Treatment Measure Clinical Study

研究目的：

①观察纳子法腹部火龙罐治疗中风后气虚型便秘患者的临床疗效及安全性。 ②观察纳子法腹部火龙罐对中风后气虚型便秘患者生活质量的影响。 ③观察纳子法腹部火龙罐治疗中风后气虚型便秘的1个月后的远期疗效。 ④建立纳子法腹部火龙罐治疗中风后气虚型便秘的临床操作规范。

Objectives of Study：

① To observe the clinical efficacy and safety of abdominal Huolong cupping with Nazi method in the treatment of patients with post-stroke Qi-deficiency constipation. ② To observe the effect of abdominal Huolong cupping with Nazi method on the quality of life of patients with Qi-deficiency constipation after stroke. (3) To observe the long-term effect of abdominal Huolong cupping with Nazi method on Qi-deficiency constipation after stroke after 1 month. ④ To establish the clinical operation standard for the treatment of post-stroke Qi-deficiency constipation with abdominal Huolong cupping with Nazi method.

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）符合中西医关于中风病及便秘的诊断标准，且中医辨证为气虚证者； （2）年龄在 18～80岁之间； （3）病程处于脑卒中恢复期或后遗症期者； （4）各项生命体征平稳，意识清醒，无明显语言障碍及听力障碍，认知功能正常； （5）观察前1周未使用治疗便秘的相关药物，1月内未接受规范、系统的便秘治疗者； （6）患者知情同意，自愿参加本研究且主动配合。

Inclusion criteria

(1) Patients who meet the diagnostic criteria of Chinese and Western medicine on stroke and constipation, and TCM syndrome differentiation is Qi deficiency; (2) Aged between 18 and 80 years old; (3) The course of the disease is in the recovery period or sequelae period of stroke; (4) All vital signs are stable, conscious, no obvious language impairment and hearing impairment, and cognitive function is normal; (5) Patients who did not use constipation related drugs within 1 week before observation, and did not receive standardized and systematic constipation treatment within 1 month; (6) The patient gave informed consent, voluntarily participated in the study and actively cooperated.

排除标准：

（1）BMI≤18.5或极度虚弱者； （2）合并有消化系统相关器质性病变、严重的内脏疾病、脏器衰竭或恶性肿瘤，研究者认为不适合参加研究者； （3）合并有帕金森、痴呆、精神病、内分泌代谢系统疾病可能引起便秘或服用相关药物引起便秘者； （4）做过肠道手术者； （5）酗酒、妊娠、哺乳期、凝血机制异常者； （6）腹部有皮肤损伤、水肿或血管病变者； （7）对艾烟不耐受或有哮喘病史者。

Exclusion criteria：

(1) Patients who meet the diagnostic criteria of Chinese and Western medicine on stroke and constipation, and TCM syndrome differentiation is Qi deficiency; (2) Aged between 18 and 80 years old; (3) The course of the disease is in the recovery period or sequelae period of stroke; (4) All vital signs are stable, conscious, no obvious language impairment and hearing impairment, and cognitive function is normal; (5) Patients who did not use constipation related drugs within 1 week before observation, and did not receive standardized and systematic constipation treatment within 1 month; (6 (1) BMI≤18.5 or extremely weak; (2) Patients with digestive system-related organic diseases, severe visceral diseases, organ failure, or malignant tumors are not considered suitable for study; (3) Patients with Parkinson's disease, dementia, mental illness, endocrine and metabolic system diseases that may cause constipation or those who take related drugs to cause constipation; (4) Patients who have had intestinal surgery; (5) alcoholism, pregnancy, lactation, abnormal coagulation mechanism; (6) abdominal skin damage, edema or vascular lesions; (7) People who are intolerant to moxa or have a history of asthma.

研究实施时间：

Study execute time：

从From 2023-12-13

至To      2025-12-31

征募观察对象时间：

Recruiting time：

从From 2024-05-10

至To      2025-12-31

干预措施：

Interventions：

组别：

试验组

样本量：

30

Group：

Test Group

Sample size：

干预措施：

纳子法腹部火龙罐

干预措施代码：

Intervention：

abdominal Huolong cupping with Nazi method

Intervention code：

组别：

对照组

样本量：

30

Group：

Control group

Sample size：

干预措施：

腹部穴位按摩

干预措施代码：

Intervention：

Abdominal acupoint massage

Intervention code：

样本总量 Total sample size ： 60

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)：

广州市

Country：

China

Province：

Guangdong Province

City：

Guangzhou city

单位(医院)：

广东省中医院

单位级别：

三甲

Institution/hospital：

Guangdong Provincial Hospital of Chinese Medicine

Level of the institution：

Grade 3 A

测量指标：

Outcomes：

指标中文名：

气虚型中风后便秘症状积分量表评分

指标类型：

次要指标

Outcome：

Score of Qi-deficiency apoplectic constipation symptom score scale

Type：

Secondary indicator

测量时间点：

治疗1周后，疗程结束后，治疗后1个月随访

测量方法：

问卷量表收集

Measure time point of outcome：

After 1 week of treatment, after the course of treatment, 1 month after treatment follow-up

Measure method：

Questionnaire scale collection

指标中文名：

便秘患者生活质量自评量表（PAC-QOL评分）

指标类型：

次要指标

Outcome：

PAC-QOL rating

Type：

Secondary indicator

测量时间点：

治疗1周后，疗程结束后，治疗后1个月随访

测量方法：

问卷量表收集

Measure time point of outcome：

After 1 week of treatment, after the course of treatment, 1 month after treatment follow-up

Measure method：

Questionnaire scale collection

指标中文名：

第一次排便时间间隔

指标类型：

次要指标

Outcome：

Time interval for first defecation

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

慢性便秘严重度评分量表（CCS评分）

指标类型：

主要指标

Outcome：

CCS rating

Type：

Primary indicator

测量时间点：

治疗1周后，疗程结束后，治疗后1个月随访

测量方法：

问卷量表收集

Measure time point of outcome：

After 1 week of treatment, after the course of treatment, 1 month after treatment follow-up

Measure method：

Questionnaire scale collection

指标中文名：

排便频率

指标类型：

次要指标

Outcome：

Defecation frequency

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：

no

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 80 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）：

随机数字表法：由研究者和评价者以外的第三方人员通过SPSS 25.0软件得出60个随机数，规定60个数字中前30个数字是试验组1，后30 个数字是对照组2，并做好随机分配卡，按顺序封好于随机不透光信封中，研究开始时则按入组的先后次序拆开相应的随机信封。

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

Random Number Table: 60 random numbers were generated by a third party other than the researcher and the evaluator through SPSS 25.0 software, and the first 30 numbers of the 60 numbers were assigned to trial group 1, the last 30 digits were control group 2, and the random allocation cards were made and sealed in order. At the beginning of the study, the random envelopes were opened according to the order of entry.

盲法：

为了更好地遵循盲法原则，在整个研究过程中严格实行研究者、操作者和统计者三分离，本研究的所有临床疗效评价、主次要观察指标的数据均由第三方进行数据统计分析，统计者不清楚分组情况及其意义。

Blinding：

In order to better follow the principle of blind method, the three separations of researchers, operators and statisticians were strictly implemented in the whole process of the study. All the data of clinical efficacy evaluation and primary and secondary observation indicators in this study were statistically analyzed by a third party, and the statisticians were not clear about the grouping and its significance.

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）：

http://www.medresman.org.cn/uc/index.aspx

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

http://www.medresman.org.cn/uc/index.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：

病理报告表病人自行填写，由专职人员协助。 电子采集和管理系统专人录入保管，第二者核对。

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

The pathological report form shall be filled out by the patient and assisted by the full-time staff. The electronic collection and management system is specially entered and kept, and the second two are checked.

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):

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