痛风间歇期降尿酸临床研究

注册号:

Registration number:

ITMCTR2025000878

最近更新日期:

Date of Last Refreshed on:

2025-04-28

注册时间:

Date of Registration:

2025-04-28

注册号状态:

Registration Status:

补注册

Retrospective registration

注册题目:

痛风间歇期降尿酸临床研究

Public title:

Clinical study of uric acid reduction during the gout interval

注册题目简写:

English Acronym:

研究课题的正式科学名称:

尿酸清颗粒治疗痛风间歇期(脾虚湿阻证)的临床研究及其对肠道菌群的影响

Scientific title:

Clinical study of uric acid clear granules in the treatment of gout intermittent phase (spleen deficiency and moisture obstruction) and its effect on intestinal flora

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:

李兴美

研究负责人:

李兆福

Applicant:

Xingmei Li

Study leader:

Zhaofu Li

申请注册联系人电话:

Applicant telephone:

15812129819

研究负责人电话:

Study leader's telephone:

+86 13187442840

申请注册联系人传真 :

Applicant Fax:

0871-65918214

研究负责人传真:

Study leader's fax:

0871-65918214

申请注册联系人电子邮件:

Applicant E-mail:

1455246277@qq.com

研究负责人电子邮件:

Study leader's E-mail:

1455246277@qq.com

申请单位网址(自愿提供):

Study leader's website(voluntary supply):

https://www.ynucm.edu.cn/

研究负责人网址(自愿提供):

Study leader's website
(voluntary supply):

https://www.ynucm.edu.cn/

申请注册联系人通讯地址:

云南省昆明市呈贡区雨花路1076号

研究负责人通讯地址:

云南省昆明市呈贡区雨花路1076号

Applicant address:

1076 Yuhua Road Chenggong District Kunming Yunnan

Study leader's address:

1076 Yuhua Road Chenggong District Kunming Yunnan

申请注册联系人邮政编码:

Applicant postcode:

650500

研究负责人邮政编码:

Study leader's postcode:

650500

申请人所在单位:

云南中医药大学

Applicant's institution:

Yunnan University 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:

XW[2022]伦审字 005-04

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:

云南中医药大学第一附属医院医学伦理委员会

Name of the ethic committee:

Medical Ethics Committee of the First Affiliated Hospital of Yunnan University of Chinese Medicine

伦理委员会批准日期:

Date of approved by ethic committee:

2024/6/13 0:00:00

伦理委员会联系人:

马军

Contact Name of the ethic committee:

Jun Ma

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 Yunnan

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 0871 6363 5609

伦理委员会联系人邮箱:

Contact email of the ethic committee:

ynszyyylunli@126.com

研究实施负责(组长)单位:

云南中医药大学第一附属医院

Primary sponsor:

The First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine

研究实施负责(组长)单位地址:

云南省昆明市光华街120号

Primary sponsor's address:

120 Guanghua Street Kunming Yunnan

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

Yunnan

市(区县):

Kunming

Country:

China

Province:

Yunnan

City:

Kunming

单位(医院):

云南中医药大学

具体地址:

云南省昆明市呈贡区雨花路1076号

Institution
hospital:

Yunnan University of Traditional Chinese Medicine

Address:

1076 Yuhua Road Chenggong District Kunming Yunnan Province

经费或物资来源:

云南省应用基础研究计划项目

Source(s) of funding:

Yunnan Province Applied Basic Research Program

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:

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:

尿酸清颗粒治疗痛风间歇期(脾虚湿阻证)的有效性和安全性评价,并观察其对痛风间歇期患者肠道菌群的影响。

Objectives of Study:

Evaluation of the effectiveness and safety of Uric acid clear granules in the treatment of intermittent gout (spleen deficiency and moisture obstruction) and its effect on the intestinal flora of patients with intermittent 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:

(1)符合西医原发性痛风诊断标准(2015年美国风湿病学会/欧洲抗风湿联盟痛风分类标准); (2)既往有痛风发作病史; (3)符合痛风间歇期分期标准(参照中华医学会风湿病分会2011年颁布的《原发性痛风治疗指南》); (4)符合2011年国家中管局《原发性痛风诊疗方案》脾虚湿阻证中医辨证标准; (5)年龄18-65岁; (6)血尿酸≥480μmol/L; (7)血尿酸≥420umol/L,且合并下列任何情况之一:痛风发作次数≥2次/年,发病年龄<40岁,肾结石、慢性肾脏疾病、高血压、糖尿病、血脂异常。 (8)自愿参加本试验并同意进入临床研究,签署知情同意书者。

Inclusion criteria

1. Meet the diagnostic criteria for primary gout (2015 American College of Rheumatology/European League Against Rheumatism classification criteria for gout); 2. Previous history of gout attacks; 3. Conform to the staging standard of intermittent stage of gout (Guidelines for the Treatment of Primary Gout issued by Rheumatology Branch of Chinese Medical Association in 2011); 4. Those who meet the TCM syndrome differentiation criteria for spleen deficiency and dampness syndrome in the Primary Gout Diagnosis and Treatment Program issued by the National Central Administration in 2011; 5. Age 18-65; 6. Blood uric acid >= 480 μmol/L; 7.Blood uric acid ≥420umol/L in combination with any of the following conditions: gout attack ≥2 times/year age of onset <40 years old kidney stones chronic kidney disease hypertension diabetes mellitus dyslipidemia. 8. Those who voluntarily participate in this trial and agree to enter the clinical research and sign the informed consent form.

排除标准:

(1)筛查时正处于痛风性关节炎急性发作期或合并有痛风石患者。 (2)过敏体质者,已知对别嘌醇或中药过敏者。 (3)严重急慢性器质性或精神性疾病。 (4)妊娠期、哺乳期妇女。 (5)慢性肾脏疾病Ⅲ-Ⅴ期的患者 ( eGFR ) < 60 ml/min/1.73 m2)。 (6)肝功能异常:血ALT、AST超出正常值1.5倍以上者。 (7)随机前2周内使用过其他降尿酸药物(别嘌醇、非布司他、丙磺舒、苯溴马隆、重组尿酸酶) (8)研究者认为依从性差,影响试验药物安全性和疗效评价,不能完成临床研究的受试者。

Exclusion criteria:

(1) Patients who are in the acute attack stage of gouty arthritis or combined with gout stones at the time of screening. (2) Allergic patients with known allergy to allopurinol or Chinese medicine. (3) Severe acute and chronic organic or psychiatric diseases. (4)Pregnant and lactating women. (5) Patients with chronic kidney disease stage III-V ( eGFR) < 60 ml/min/1.73 m2). (6) Abnormal liver function: blood ALT AST exceeds the normal value more than 1.5 times. (7) Use of other uric acid-lowering drugs (allopurinol febuxostat probenecid benzbromarone recombinant uricase) within 2 weeks before randomization (8) Subjects who in the opinion of the investigator have poor compliance which affects the evaluation of the safety and efficacy of the test drug and who are unable to complete the clinical study. Translated with www.DeepL.com/Translator (free version)

研究实施时间:

Study execute time:

From 2024-06-20

To      2025-11-30

征募观察对象时间:

Recruiting time:

From 2024-06-20

To      2025-11-30

干预措施:

Interventions:

组别:

中西医结合组

样本量:

60

Group:

Combined Chinese and Western medicine group

Sample size:

干预措施:

别嘌醇和尿酸清颗粒

干预措施代码:

3

Intervention:

allopurinol and uric acid clear granules

Intervention code:

组别:

西药组

样本量:

60

Group:

Western Medicine Group

Sample size:

干预措施:

别嘌醇

干预措施代码:

1

Intervention:

allopurinol

Intervention code:

组别:

中药组

样本量:

60

Group:

Chinese medicine group

Sample size:

干预措施:

尿酸清颗粒

干预措施代码:

2

Intervention:

Uric acid clearing granules

Intervention code:

样本总量 Total sample size : 180

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

Yunnan

市(区县):

Kunming

Country:

China

Province:

Yunnan

City:

Kunming

单位(医院):

云南中医药大学第一附属医院

单位级别:

三级甲等中医院

Institution/hospital:

The First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine

Level of the institution:

Tertiary hospital of traditional Chinese medicine

测量指标:

Outcomes:

指标中文名:

尿常规

指标类型:

附加指标

Outcome:

Urinalysis

Type:

Additional indicator

测量时间点:

入选治疗时,服药后4周,8周,12周

测量方法:

测尿常规

Measure time point of outcome:

When enrolled in treatment, 4 weeks, 8 weeks, 12 weeks after taking the drug.

Measure method:

Test urinalysis

指标中文名:

各时点血尿酸较基线的变化值

指标类型:

主要指标

Outcome:

Change from baseline in blood uric acid at each time point

Type:

Primary indicator

测量时间点:

服药后4周,8周,12周

测量方法:

计算各时点血尿酸较基线的变化值

Measure time point of outcome:

4 weeks, 8 weeks, 12 weeks post-dose

Measure method:

Calculate the change from baseline in blood uric acid at each time point

指标中文名:

血脂(总胆固醇、高密度脂蛋白胆固醇、低密度脂蛋白胆固醇、甘油三酯)

指标类型:

附加指标

Outcome:

Lipids (total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides)

Type:

Additional indicator

测量时间点:

入选治疗时,服药后12周

测量方法:

检测总胆固醇、高密度脂蛋白胆固醇、低密度脂蛋白胆固醇、甘油三酯

Measure time point of outcome:

When enrolled in treatment, 12 weeks after taking the drug

Measure method:

Test for total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides

指标中文名:

炎症指标(C反应蛋白、血沉)

指标类型:

次要指标

Outcome:

Inflammation indicators (C-reactive protein, blood sedimentation)

Type:

Secondary indicator

测量时间点:

入选治疗时,服药后12周

测量方法:

血液检测C反应蛋白、血沉)

Measure time point of outcome:

When enrolled in treatment, 12 weeks after taking the drug

Measure method:

Blood test for C-reactive protein, blood sedimentation

指标中文名:

肾功能(血清肌酐,尿素氮,肾小球滤过率)

指标类型:

次要指标

Outcome:

Kidney function (Serum creatinine, urea nitrogen, glomerular filtration rate)

Type:

Secondary indicator

测量时间点:

入选治疗时,服药后4周,8周,12周

测量方法:

血液检测血清肌酐和尿素氮,计算肾小球滤过率

Measure time point of outcome:

When enrolled in treatment, 4 weeks, 8 weeks, 12 weeks after taking the drug

Measure method:

Blood is measured for serum creatinine and urea nitrogen and glomerular filtration rate is calculated

指标中文名:

痛风急性发作次数

指标类型:

次要指标

Outcome:

The frequency of acute gout attack

Type:

Secondary indicator

测量时间点:

服药后12周内

测量方法:

记录服药12周内急性痛风的发作次数

Measure time point of outcome:

Within 12 weeks after taking the drug

Measure method:

The number of episodes of acute gout within 12 weeks of taking the drug was recorded

指标中文名:

血常规

指标类型:

附加指标

Outcome:

Blood routine

Type:

Additional indicator

测量时间点:

入选治疗时,服药后4周,8周,12周

测量方法:

测血常规

Measure time point of outcome:

入选治疗时,服药后4周,8周,12周

Measure method:

Test blood routine

指标中文名:

体重和体重指数

指标类型:

附加指标

Outcome:

weight and BMI

Type:

Additional indicator

测量时间点:

入选治疗时,服药后12周

测量方法:

入选治疗时,服药后12周

Measure time point of outcome:

When enrolled in treatment, 12 weeks after taking the drug

Measure method:

Measure weight, height, and calculate body mass index

指标中文名:

血尿酸达标率

指标类型:

主要指标

Outcome:

Blood uric acid compliance rate

Type:

Primary indicator

测量时间点:

服药前,服药后4周,8周,12周

测量方法:

计算尿酸服药12周后血尿酸降至360μmol/Ll的痛风患者比例

Measure time point of outcome:

Pre-dose 4 weeks 8 weeks 12 weeks post-dose

Measure method:

Calculate the percentage of gout patients whose blood uric acid dropped to 360 μmol/Ll after 12 weeks of medication.

指标中文名:

空腹血糖

指标类型:

附加指标

Outcome:

Fasting blood sugar

Type:

Additional indicator

测量时间点:

入选治疗时,服药后12周

测量方法:

检测空腹血糖

Measure time point of outcome:

When enrolled in treatment, 12 weeks after taking the drug

Measure method:

Test fasting blood glucose

指标中文名:

各时点血尿酸较基线变化的百分比

指标类型:

主要指标

Outcome:

Percentage change from baseline in blood uric acid at each time point

Type:

Primary indicator

测量时间点:

服药后4周,8周,12周

测量方法:

计算各时点血尿酸较基线下降的百分比

Measure time point of outcome:

4 weeks, 8 weeks, 12 weeks post-dose

Measure method:

Calculate the percentage decrease in blood uric acid from baseline at each time point

指标中文名:

心电图

指标类型:

附加指标

Outcome:

electrocardiogram

Type:

Additional indicator

测量时间点:

入选治疗时,服药后12周

测量方法:

做心电图

Measure time point of outcome:

When enrolled in treatment, 12 weeks after taking the drug.

Measure method:

Do an electrocardiogram

指标中文名:

肠道菌群变化情况

指标类型:

次要指标

Outcome:

Changes in the intestinal flora

Type:

Secondary indicator

测量时间点:

入选治疗时,服药后12周

测量方法:

肠道微生物高通量测序和生物信息学分析

Measure time point of outcome:

When enrolled in treatment, 12 weeks after taking the drug.

Measure method:

Detection of alanine aminotransferase, glutamate aminotransferase

指标中文名:

中医证候评分

指标类型:

次要指标

Outcome:

TCM syndrome score

Type:

Secondary indicator

测量时间点:

入选治疗时,服药后12周

测量方法:

中医证候评分量表计算评分

Measure time point of outcome:

When enrolled in treatment, 12 weeks after taking the drug

Measure method:

The TCM Syndrome Rating Scale calculates the score

指标中文名:

肝功能(谷丙转氨酶,谷草转氨酶)

指标类型:

附加指标

Outcome:

Liver function (ALT,AST)

Type:

Additional indicator

测量时间点:

入选治疗时,服药后4周,8周,12周

测量方法:

检测谷丙转氨酶,谷草转氨酶

Measure time point of outcome:

When enrolled in treatment, 4 weeks, 8 weeks, 12 weeks after taking the drug.

Measure method:

Detection of alanine aminotransferase, glutamate aminotransferase

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:

feces

Tissue:

人体标本去向

使用后保存

说明

Fate of sample 

Preservation 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):

随机化由独立统计学专家使用SPSS软件通过计算机生成.

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

Randomization is computer-generated by independent statisticians using SPSS software.

盲法:

因药物性状没法设盲法

Blinding:

Cannot be blinded due to drug properties

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):

研究完成后,选择采用网络平台公开原始数据,网址:https://datadryad.org.

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

After the completion of the study choose to use the online platform to disclose the raw data URL: https://datadryad.org

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:

1.数据收集和管理数据的组成由专业统计人员组成。研究人员建立病例报告表收集数据,统计人员根据病例报告表的项目,将使用医院临床研究系统录入电子数据,并设置录入时的逻辑检查资格,建立本实验专用的数据库系统。 2.研究者将签名的病例报告表和稽查声明提供给数据管理员,数据管理员将检查日期、分组标准、剔除标准和缺失值。对数据进行仔细核查,研究者、数据管理员和统计师共同对数据中未解决的问题进行最终审核。数据审核时对所有数据质疑、脱落和与方案偏离的病例,合并用药和不良事件的发生情况进行讨论,进行统计分析人群划分,讨论并确定最终的《数据划分决议》。

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

1.Data collection and management The composition of data consists of professional statisticians. The researcher establishes the case report form to collect the data and the statistician will use the hospital clinical research system to enter the electronic data according to the items in the case report form and set the logical check qualification at the time of entry and set up the database system dedicated to this experiment. 2. The investigator will provide the signed case report form and audit statement to the data manager who will check the date grouping criteria exclusion criteria and missing values. The data were scrutinized and the investigator data manager and statistician worked together to provide a final review of unresolved issues in the data. The data review discusses all cases of data questioning dropouts and deviations from the protocol the occurrence of comorbid medications and adverse events performs a statistical analysis population delineation and discusses and finalizes the final Data Delineation Resolution. Translated with www.DeepL.com/Translator (free version)

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):

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