Cohort study on sequential treatment of Gout by stages of Tongfengxiaotong granule and Uricoqing granule

注册号:

Registration number:

ITMCTR2200005758

最近更新日期:

Date of Last Refreshed on:

2022-03-24

注册时间:

Date of Registration:

2022-03-24

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

痛风消痛颗粒、尿酸清颗粒分期序贯治疗痛风的队列研究

Public title:

Cohort study on sequential treatment of Gout by stages of Tongfengxiaotong granule and Uricoqing granule

注册题目简写:

English Acronym:

研究课题的正式科学名称:

痛风消痛颗粒、尿酸清颗粒分期序贯治疗痛风的队列研究

Scientific title:

Cohort study on sequential treatment of Gout by stages of Tongfengxiaotong granule and Uricoqing granule

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:

ChiCTR2200057964 ; ChiMCTR2200005758

申请注册联系人:

凌丽

研究负责人:

彭江云

Applicant:

LingLi

Study leader:

Peng Jiangyun

申请注册联系人电话:

Applicant telephone:

18787471408

研究负责人电话:

Study leader's telephone:

13099963399

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:

1780497320@qq.com

研究负责人电子邮件:

Study leader's E-mail:

pengjiangyun@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:

云南省昆明市五华区120号

研究负责人通讯地址:

云南省昆明市五华区120号

Applicant address:

120 Wuhua District, Kunming City, Yunnan Province

Study leader's address:

120 Wuhua District, Kunming City, Yunnan Province

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:

云南省中医医院

Applicant's institution:

Yunnan Hospital of Traditional 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:

01/2021.11.9,ICF:01/2021.11.9

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:

云南中医药大学第一附属医院伦理审查批件

Name of the ethic committee:

The first Affiliated Hospital of Yunnan University of Chinese Medicine ethics review approval

伦理委员会批准日期:

Date of approved by ethic committee:

2021/11/9 0:00:00

伦理委员会联系人:

马军

Contact Name of the ethic committee:

MaJun

伦理委员会联系地址:

云南省昆明市西山区西园路48号

Contact Address of the ethic committee:

48 Xiyuan Road, Xishan District, Kunming City, Yunnan Province

伦理委员会联系人电话:

Contact phone of the ethic committee:

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:

云南省中医医院

Primary sponsor:

Yunnan Hospital of Traditional Chinese Medicine

研究实施负责(组长)单位地址:

云南省昆明市五华区120号

Primary sponsor's address:

120 Wuhua District, Kunming City, Yunnan Province

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

云南省

市(区县):

Country:

China

Province:

yunnan

City:

单位(医院):

云南省中医医院

具体地址:

云南省昆明市五华区120号

Institution
hospital:

Yunnan Hospital of Traditional Chinese Medicine

Address:

120 Wuhua District, Kunming City, Yunnan Province

经费或物资来源:

云财教(2021)157号云南省中医(风湿病)临床医学研究中心-中医药(傣彝医)治疗类风湿关节炎及痛风的临床评价及基础研究

Source(s) of funding:

Yuncaijiao (2021) No. 157 Yunnan TCM (Rheumatism) Clinical Medical Research Center - Clinical evaluation and basic research on the treatment of rheumatoid arthritis and gout by TCM (Dai yi Medicine)

研究疾病:

痛风

研究疾病代码:

Target disease:

gout

Target disease code:

研究类型:

Study type:

干预性研究

Interventional study

研究设计:

Study design:

非随机对照试验

Non randomized control

研究所处阶段:

Study phase:

其它

Others

研究目的:

本课题通过前瞻性队列研究“痛风消痛颗粒,尿酸清颗粒”分期序贯疗法对痛风急性期和间歇期临床症状、体征、中医证候、血尿酸、C反应蛋白、血沉等指标的干预作用,验证其抗炎、镇痛、降尿酸、防止疾病复发的临床疗效和安全性。为中医药防治痛风提供安全有效的方药,提高痛风中医防治水平。

Objectives of Study:

This topic through the prospectie cohort study "gout XiaoTong particles, uric acid particles" stage sequential therapy for acute phase of gout and intermittent period clinical signs and symptoms, TCM syndrome, blood uric acid, intervention of indicators, such as c-reactive protein and blood sedimentation, verify its anti-inflammatory and analgesic, blood uric acid to prevent the recurrence of disease, clinical efficacy and safety.To provide safe and effective prescriptions for TCM prevention and treatment of gout, improve the level of TCM prevention and treatment of gout.

药物成份或治疗方案详述:

Description for medicine or protocol of treatment in detail:

纳入标准:

2.1急性期纳入标准:①符合西医急性痛风性关节炎诊断标准; ②急性期符合湿热蕴结证者;③发病时未用其他药物及方法治疗者;④自愿参加本试验并同意进入临床研究,⑤签署知情同意书者。 2.2间歇期纳入标准:①当患者疼痛VAS评分≤2分,且血尿酸值≥420μmol/L时,纳入间歇期治疗;②间歇期符合脾虚湿阻证者进入中药组,其余患者进入西药组。

Inclusion criteria

2.1 Inclusion criteria of acute stage: ① Meet the diagnostic criteria of acute gout arthritis in Western medicine;(2) in the acute stage, it meets the requirement of dampness and heat;(3) patients who were not treated with other drugs and methods at the time of onset;Those who volunteered to participate in the study and agreed to enter the clinical study, and those who signed the informed consent.2.2 Inclusion criteria for intermittent therapy: ① Patients with pain VAS ≤2 and blood uric acid ≥420μmol/L were included in intermittent therapy;② Patients with spleen deficiency and dampness resistance were assigned to the Chinese medicine group, while the rest were assigned to the Western medicine group.

排除标准:

①不符合上述纳入标准者;②继发性痛风,由类风湿关节炎、化脓性关节炎、创伤性关节炎、银屑性关节炎、假性痛风、红斑狼疮等疾病引起的关节病变。化疗、放疗、慢性铅中毒、急性梗阻性肾病等致关节病变;③急性期关节剧烈疼痛无法忍受(患者评价10级);④长期服用以下药物如:双氢克尿噻、速尿、利尿酸、吡嗪酰胺、小剂量阿司匹林等,以及含有上述成分的药品如复方降压片等,所致痛风者;⑤过敏体质者、已知对本药组成成份过敏者;⑥妊娠期、哺乳期妇女;⑦精神病患者;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;⑨有严重心、脑、肝、肾等并发症或合并其它严重原发疾病;⑩血ALT、AST、Cr超出正常值1倍以上者;11正在参加其他临床试验的患者。

Exclusion criteria:

① Those who do not meet the above inclusion criteria;② Secondary gout, arthritis caused by rheumatoid arthritis, suppurative arthritis, traumatic arthritis, silver arthritis, pseudogout, lupus erythematosus and other diseases.Chemotherapy, radiotherapy, chronic lead poisoning, acute obstructive nephropathy and other joint lesions;③ Acute joint pain was unbearable (grade 10);④ Long-term use of the following drugs, such as dihydrokeuride, furosemide, risuric acid, pyrazinamide, low-dose aspirin, and drugs containing the above ingredients, such as compound antihypertensive tablets, caused by gout;⑤ Allergic constitution, known to be allergic to the composition of the drug;⑥ Pregnant and lactating women;⑦ Mental patients;(8) Suspected or have a history of alcohol or drug abuse, or other diseases that, according to the judgment of the investigator, reduce the possibility of inclusion or complicate inclusion, such as frequent changes in the work environment and other conditions that are easy to cause loss of follow-up;⑨ Severe complications of heart, brain, liver, kidney or other serious primary diseases;⑩ blood ALT, AST, Cr more than 1 times the normal value;11 Patients who are participating in other clinical trials.

研究实施时间:

Study execute time:

From 2022-04-30

To      2023-02-01

征募观察对象时间:

Recruiting time:

From 2022-04-30

To      2022-11-30

干预措施:

Interventions:

组别:

试验组

样本量:

100

Group:

Experimental group

Sample size:

干预措施:

痛风消痛颗粒和尿酸清颗粒

干预措施代码:

Intervention:

Gout analgesic granule and Uricurate granule

Intervention code:

组别:

对照组

样本量:

100

Group:

The control group

Sample size:

干预措施:

秋水仙碱片和苯溴马隆片

干预措施代码:

Intervention:

Colchicine tablets and Benzbromarone tablet

Intervention code:

样本总量 Total sample size : 200

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

云南省

市(区县):

Country:

China

Province:

yunnan

City:

单位(医院):

云南省中医医院

单位级别:

三级甲等

Institution/hospital:

Yunnan Hospital of Traditional Chinese Medicine

Level of the institution:

Third rate A

国家:

中国

省(直辖市):

云南省

市(区县):

Country:

China

Province:

yunnan

City:

单位(医院):

普洱市中医医院

单位级别:

三级甲等

Institution/hospital:

Pu 'er Traditional Chinese Medicine Hospital

Level of the institution:

Third rate A

国家:

中国

省(直辖市):

云南省

市(区县):

Country:

China

Province:

yunnan

City:

单位(医院):

宁洱县中医医院

单位级别:

二级甲等

Institution/hospital:

Ninger County Hospital of Traditional Chinese Medicine

Level of the institution:

Second rate A

国家:

中国

省(直辖市):

云南省

市(区县):

Country:

China

Province:

yunnan

City:

单位(医院):

保山市中医医院

单位级别:

三级甲等

Institution/hospital:

Baoshan Hospital of Traditional Chinese Medicine

Level of the institution:

Third rate A

国家:

中国

省(直辖市):

云南省

市(区县):

Country:

China

Province:

yunnan

City:

单位(医院):

勐海县中医医院

单位级别:

二级甲等

Institution/hospital:

Menghai County Traditional Chinese Medicine Hospital

Level of the institution:

Second rate A

国家:

中国

省(直辖市):

云南省

市(区县):

Country:

China

Province:

yunnan

City:

单位(医院):

昭通市中医医院

单位级别:

三级甲等

Institution/hospital:

Zhaotong Traditional Chinese Medicine Hospital

Level of the institution:

Third rate A

国家:

中国

省(直辖市):

云南省

市(区县):

Country:

China

Province:

yunnan

City:

单位(医院):

镇雄县中医医院

单位级别:

二级甲等

Institution/hospital:

Zhenxiong County Traditional Chinese Medicine Hospital

Level of the institution:

Second rate A

国家:

中国

省(直辖市):

云南省

市(区县):

Country:

China

Province:

yunnan

City:

单位(医院):

曲靖市中医医院

单位级别:

三级甲等

Institution/hospital:

Qujing Hospital of Traditional Chinese Medicine

Level of the institution:

Third rate A

测量指标:

Outcomes:

指标中文名:

尿常规

指标类型:

次要指标

Outcome:

Routine urine

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血沉

指标类型:

主要指标

Outcome:

Blood sedimentation

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

尿尿酸

指标类型:

主要指标

Outcome:

Urinary uric acid

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

C反应蛋白

指标类型:

主要指标

Outcome:

C-reactive protein

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血糖

指标类型:

主要指标

Outcome:

Blood sugar

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血脂

指标类型:

主要指标

Outcome:

Blood fat

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肾功能

指标类型:

主要指标

Outcome:

renal function

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

粪便常规

指标类型:

次要指标

Outcome:

Feces regular

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血常规

指标类型:

次要指标

Outcome:

Routine blood

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肝功能

指标类型:

主要指标

Outcome:

Liver function

Type:

Primary 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:

尚未开始

Not yet recruiting

年龄范围:

最小
Min age years
最大
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):

不做随机试验

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

No randomized trials

盲法:

Blinding:

是否共享原始数据:

IPD sharing:

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):

中国知网http://www.cnki.net/

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

CNKIhttp://www.cnki.net/

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

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):

ITMCTR BJ-ICP:07032215-5 Tip: IE8 is recommended Use the system with widescreen display resolution above