痛风方治疗急性痛风性关节炎的疗效评价及其对肠道微生物组的重建和免疫机制研究

注册号:

Registration number:

ITMCTR2023000011

最近更新日期:

Date of Last Refreshed on:

2023-12-13

注册时间:

Date of Registration:

2023-05-24

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

痛风方治疗急性痛风性关节炎的疗效评价及其对肠道微生物组的重建和免疫机制研究

Public title:

Efficacy evaluation of Tongfeng Fang and its influence on reconstruction of gut microbiome and immune function in acute gouty arthritis

注册题目简写:

English Acronym:

研究课题的正式科学名称:

痛风方治疗急性痛风性关节炎的疗效评价及其对肠道微生物组的重建和免疫机制研究

Scientific title:

Efficacy evaluation of Tongfeng Fang and its influence on reconstruction of gut microbiome and immune function in acute gouty arthritis

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:

马芳

研究负责人:

马芳

Applicant:

Ma Fang

Study leader:

Ma Fang

申请注册联系人电话:

Applicant telephone:

13641090968

研究负责人电话:

Study leader's telephone:

13641090968

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:

anjanette49@126.com

研究负责人电子邮件:

Study leader's E-mail:

anjanette49@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:

北京市海淀区西苑操场1号

研究负责人通讯地址:

北京市海淀区西苑操场1号

Applicant address:

1 Xiyuan Playground, Haidian District, Beijing, China

Study leader's address:

1 Xiyuan Playground, Haidian 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:

中国中医科学院西苑医院

Applicant's institution:

Xiyuan Hospital of 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:

2023XLA026-4

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:

中国中医科学院西苑医院医学伦理委员会

Name of the ethic committee:

EC of Xi Yuan Hospital of China Academy of Chinese Medical Sciences

伦理委员会批准日期:

Date of approved by ethic committee:

2023/4/20 0:00:00

伦理委员会联系人:

訾明杰

Contact Name of the ethic committee:

Zi Mingjie

伦理委员会联系地址:

北京市海淀区西苑操场1号

Contact Address of the ethic committee:

1 Xiyuan Playground, Haidian District, Beijing, China

伦理委员会联系人电话:

Contact phone of the ethic committee:

010-62835646

伦理委员会联系人邮箱:

Contact email of the ethic committee:

xiyuanlunli@126.com

研究实施负责(组长)单位:

中国中医科学院西苑医院

Primary sponsor:

Xiyuan Hospital of China Academy of Chinese Medical Sciences

研究实施负责(组长)单位地址:

北京市海淀区西苑操场1号

Primary sponsor's address:

1 Xiyuan Playground, Haidian 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

市(区县):

海淀区

Country:

China

Province:

Beijing

City:

Haidian District

单位(医院):

中国中医科学院西苑医院

具体地址:

北京市海淀区西苑操场1号

Institution
hospital:

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Address:

1 Xiyuan Playground, Haidian District, Beijing, China

经费或物资来源:

中国中医科学院科技创新工程项目

Source(s) of funding:

Scientific and technological innovation project of Chinese Medical Sciences

研究疾病:

急性痛风性关节炎

研究疾病代码:

Target disease:

acute gouty arthritis

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:

评价痛风方治疗痛风性关节炎“湿热蕴结证”的疗效和安全性;明确痛风方对急性痛风关节炎肠道微生物组的结构和功能的作用;阐释痛风方治疗急性痛风关节炎重建肠道微生物对机体免疫调节和尿酸代谢的影响及可能机制。

Objectives of Study:

To evaluate the efficacy and safety of Tongfeng Fang in the treatment of "dampness-heat accumulation syndrome" of gouty arthritis. To clarify the effect of Tongfeng Fang on the structure and function of intestinal microbiome in acute gouty arthritis. To explore the effect and possible mechanism of acute gouty arthritis treatment with Tongfeng Fang on immune regulation and uric acid metabolism by reconstructing intestinal microorganisms.

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符合原发性急性痛风性关节炎诊断标准及中医“湿热蕴结证”辨证标准者。 ②年龄 18-70 岁,性别不限。 ③急性起病,本次发作病程在 48 小时内。 ④本次发病以来未服用相关治疗药物。 ⑤知情同意,志愿受试。

Inclusion criteria

①Those who meet the diagnostic criteria of primary acute gouty arthritis and the syndrome differentiation criteria of TCM "damp-heat syndrome". ② Male and female patients aged 18-70 years. ③Acute onset, the course of the attack within 48 hours. ④No relevant therapeutic drugs have been taken since the onset of the disease. ⑤Informed consent, voluntary subjects.

排除标准:

①继发性痛风如肾功能衰竭肿瘤化疗和/或放疗等; ②对本次研究用药过敏者; ③有严重心肝肺造血系统或影响其生存的严重疾病如肿瘤艾滋病ALT 或 AST〉2N(N 为正常值上限);SCr≥132mmol/L(1.5mg/dl);有临床意义的心律失常; 血白细胞<3.0×10^9/L; ④由类风湿关节炎、化脓性关节炎、创伤性关节炎、银屑病关节炎、假性痛风、红斑狼疮等疾病引起的关节病变; ⑤由利尿剂、含有利尿剂的复方降压药、乙胺丁醇、吡嗪酰胺、阿司匹林等药物所致的高尿酸血症及痛风; ⑥本次发病后已使用其他治疗痛风的中西药物; ⑦妊娠期、哺乳期妇女; ⑧怀疑或确有酒精、药物滥用病史,或者根据研究者的判断,具有降低入组可能性或使入组复杂化的其他病变,如工作环境经常变动等易造成失访的情况。

Exclusion criteria:

①Secondary gout, such as renal failure, tumor chemotherapy and/or radiotherapy; ②Patients who were allergic to the drug in this study; ③Have serious heart, liver, lung, hematopoietic system or affect their survival of serious diseases, such as tumor, AIDS; ALT or AST > 2N (N is the upper limit of normal); SCr≥132mmol/L (1.5 mg/dl); Arrhythmia of clinical significance; white blood cell<3.0 times 10^9/L; ④Joint lesions caused by rheumatoid arthritis, pyogenic arthritis, traumatic arthritis, psoriatic arthritis, pseudogout, lupus erythematosus and other diseases; ⑤Hyperuricemia and gout caused by diuretics, compound antihypertensive drugs containing diuretics, ethambutol, pyrazinamide, aspirin and other drugs; ⑥Hyperuricemia and gout caused by diuretics, compound antihypertensive drugs containing diuretics, ethambutol, pyrazinamide, aspirin and other drugs; ⑦Pregnant and lactating women; ⑧Suspected or indeed a history of alcohol or drug abuse, or according to the judgment of the researchers, with the possibility of reducing or complicating the inclusion of other lesions, such as frequent changes in the working environment and other easy to cause the loss of follow-up.

研究实施时间:

Study execute time:

From 2021-10-01

To      2024-10-01

征募观察对象时间:

Recruiting time:

From 2023-09-01

To      2024-06-01

干预措施:

Interventions:

组别:

对照组

样本量:

30

Group:

Control group

Sample size:

干预措施:

洛索洛芬钠片60mg+痛风方颗粒模拟剂

干预措施代码:

Intervention:

Loxoprofen Sodium Tablets 60mg + Tongfeng Fang granule simulant

Intervention code:

组别:

试验组

样本量:

60

Group:

Test group

Sample size:

干预措施:

痛风方颗粒+洛索洛芬钠模拟片60mg

干预措施代码:

Intervention:

Tongfeng Fang granule + Loxoprofen sodium analogue tablet 60mg

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):

北京市

市(区县):

西城区

Country:

China

Province:

Beijing

City:

Xicheng District

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 of China Academy of Chinese Medical Sciences

Level of the institution:

Tertiary A Hospital

国家:

中国

省(直辖市):

北京市

市(区县):

海淀区

Country:

China

Province:

Beijing

City:

Haidian District

单位(医院):

中国中医科学院西苑医院

单位级别:

三级甲等

Institution/hospital:

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Level of the institution:

Tertiary A Hospital

国家:

中国

省(直辖市):

黑龙江省

市(区县):

哈尔滨市

Country:

China

Province:

Heilongjiang Province

City:

Harbin Municipality

单位(医院):

哈尔滨医科大学基础医学院

单位级别:

三级甲等

Institution/hospital:

School of Basic Medical Sciences, Harbin Medical University

Level of the institution:

Tertiary A Hospital

测量指标:

Outcomes:

指标中文名:

血尿酸

指标类型:

次要指标

Outcome:

blood uric acid

Type:

Secondary indicator

测量时间点:

治疗前后

测量方法:

Measure time point of outcome:

Before and after treatment

Measure method:

指标中文名:

血常规

指标类型:

副作用指标

Outcome:

blood routine examination

Type:

Adverse events

测量时间点:

治疗前后

测量方法:

Measure time point of outcome:

Before and after treatment

Measure method:

指标中文名:

服药后的不适症状

指标类型:

副作用指标

Outcome:

Symptoms of discomfort after taking medication

Type:

Adverse events

测量时间点:

治疗前后

测量方法:

Measure time point of outcome:

Before and after treatment

Measure method:

指标中文名:

大便常规

指标类型:

副作用指标

Outcome:

stool routine

Type:

Adverse events

测量时间点:

治疗前后

测量方法:

Measure time point of outcome:

Before and after treatment

Measure method:

指标中文名:

中医证候积分

指标类型:

次要指标

Outcome:

TCM syndrome score

Type:

Secondary indicator

测量时间点:

治疗前后

测量方法:

Measure time point of outcome:

Before and after treatment

Measure method:

指标中文名:

肾功能

指标类型:

副作用指标

Outcome:

kidney function tests

Type:

Adverse events

测量时间点:

治疗前后

测量方法:

Measure time point of outcome:

Before and after treatment

Measure method:

指标中文名:

心电图

指标类型:

副作用指标

Outcome:

electrocardiogram

Type:

Adverse events

测量时间点:

治疗前后

测量方法:

Measure time point of outcome:

Before and after treatment

Measure method:

指标中文名:

疼痛减轻起效时间

指标类型:

次要指标

Outcome:

Time to onset of pain relief

Type:

Secondary indicator

测量时间点:

治疗前后

测量方法:

Measure time point of outcome:

Before and after treatment

Measure method:

指标中文名:

疼痛评分(VAS 评分)

指标类型:

主要指标

Outcome:

Visual analog scale test

Type:

Primary indicator

测量时间点:

治疗前后

测量方法:

Measure time point of outcome:

Before and after treatment

Measure method:

指标中文名:

肝功能

指标类型:

副作用指标

Outcome:

liver function tests

Type:

Adverse events

测量时间点:

治疗前后

测量方法:

Measure time point of outcome:

Before and after treatment

Measure method:

指标中文名:

C-反应蛋白

指标类型:

次要指标

Outcome:

C-reactive protein

Type:

Secondary indicator

测量时间点:

治疗前后

测量方法:

Measure time point of outcome:

Before and after treatment

Measure method:

指标中文名:

尿常规

指标类型:

副作用指标

Outcome:

routine urinalysis

Type:

Adverse events

测量时间点:

治疗前后

测量方法:

Measure time point of outcome:

Before and after treatment

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

尿液

组织:

Sample Name:

urine

Tissue:

人体标本去向

使用后销毁

说明

Fate of sample 

Destruction after use

Note:

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:

标本中文名:

粪便

组织:

Sample Name:

Faeces

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:

正在进行

Recruiting

年龄范围:

最小 18
Min age years
最大 70
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):

统计学专业人员应用 SAS 统计软件区组随机,应用 PROC PLAN 语句,给定种子数,产生随机数字表,将筛选合格患者按纳入先后顺序随机分配。

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

Statistical professionals applied SAS statistical software to randomize, applied PROC PLAN statement, given the seed number, generated a table of random numbers, and randomly assigned qualified patients according to the order of inclusion.

盲法:

Blinding:

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):

在试验完成后通过文章发表

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

Publish paper after the trial complete

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:

病例记录表

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

Case Record Form, CRF

数据管理委员会:

Data Managemen Committee:

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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