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Clinical observation of Xiaodian Tongluo Recipe in the treatment of recurrent skin allergic purpura in children

注册号：

Registration number：

ITMCTR2100005247

最近更新日期：

Date of Last Refreshed on：

2021-08-28

注册时间：

Date of Registration：

2021-08-28

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

消癜通络方治疗儿童反复皮肤型过敏性紫癜的临床观察研究

Public title：

Clinical observation of Xiaodian Tongluo Recipe in the treatment of recurrent skin allergic purpura in children

注册题目简写：

English Acronym：

研究课题的正式科学名称：

消癜通络方治疗儿童反复皮肤型过敏性紫癜的临床观察研究

Scientific title：

Clinical observation of Xiaodian Tongluo Recipe in the treatment of recurrent skin allergic purpura in children

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：

ChiCTR2100050535 ; ChiMCTR2100005247

申请注册联系人：

韩姗姗

研究负责人：

韩姗姗

Applicant：

HanShanshan

Study leader：

HanShanshan

申请注册联系人电话：

Applicant telephone：

15093292672

研究负责人电话：

Study leader's telephone：

15093292672

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：

15093292672@163.com

研究负责人电子邮件：

Study leader's E-mail：

15093292672@163.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：

河南省郑州市金水区人民路19号院

研究负责人通讯地址：

河南省郑州市金水区人民路19号院

Applicant address：

Courtyard 19, Renmin Road, Jinshui District, Zhengzhou City, Henan Province

Study leader's address：

Courtyard 19, Renmin Road, Jinshui District, Zhengzhou City, Henan 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：

河南中医药大学第一附属医院

Applicant's institution：

The First Affiliated Hospital of Henan 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：

2021HL-133-02

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：

河南中医药大学第一附属医院伦理委员会

Name of the ethic committee：

Ethics Committee of the First Affiliated Hospital of Henan University of traditional Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

2021/6/8 0:00:00

伦理委员会联系人：

王春芳

Contact Name of the ethic committee：

Wang Chunfang

伦理委员会联系地址：

河南省郑州市金水区人民路19号院

Contact Address of the ethic committee：

Courtyard 19, Renmin Road, Jinshui District, Zhengzhou City, Henan Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

0371-66285929

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：

河南中医药大学第一附属医院

Primary sponsor：

The First Affiliated Hospital of Henan University of traditional Chinese Medicine

研究实施负责（组长）单位地址：

河南省郑州市金水区人民路19号院

Primary sponsor's address：

Courtyard 19, Renmin Road, Jinshui District, Zhengzhou City, Henan 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)：

河南

市(区县)：

郑州

Country：

China

Province：

Henan

City：

Zhengzhou

单位(医院)：

河南中医药大学第一附属医院

具体地址：

河南省郑州市金水区人民路19号院

Institution
hospital：

The First Affiliated Hospital of Henan University of traditional Chinese Medicine

Address：

Courtyard 19, Renmin Road, Jinshui District, Zhengzhou City, Henan Province

经费或物资来源：

无

Source(s) of funding：

No funds were provided

研究疾病：

过敏性紫癜

研究疾病代码：

Target disease：

Henoch-Schonlein Purpura

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：

II期临床试验

Phase II clinical trial

研究目的：

（1）为临床难治性皮肤型过敏性紫癜提供有效的中医治疗方案。 （2）为后续进一步挖掘中医药治疗难治性皮肤型过敏性紫癜的具体机制研究奠定临床基础。

Objectives of Study：

（1）To provide an effective TCM treatment scheme for clinical refractory skin type allergic purpura. （2）It lays a clinical foundation for further exploring the specific mechanism of traditional Chinese medicine in the treatment of refractory skin type allergic purpura.

药物成份或治疗方案详述：

研究内容、设计方案 本研究采用前瞻性研究方法，观察消癜通络方对HSP患儿的临床疗效及不良反应的影响。 筛选河南中医药大学一附院儿科门诊和病区2～18岁辨证为血热妄行证非肾炎型反复发作的HSP的门诊及住院患儿为研究对象，随机分为中医组及西医组，中医组采用消癜通络方治疗，西医组予氯雷他定+泼尼松治疗，2组患儿共治疗4周，随访3月，每周评价患儿的皮疹疗效及全身症状缓解情况，观察不良反应，统计复发率及肾损发生率，并检测0～4周患儿的血尿常规、24小时尿蛋白、肝肾功及0周、4周免疫六项指标水平，进行统计分析。 实验方法和步骤 （1）受试者招募和分组 采用门诊和住院病历筛选方法，招募符合纳入标准的辨证属于风热伤络及血热妄行证的HSP患儿60例，采用随机的方法，随机分为消癜通络组30例、西医组30例，并登记受试者信息，签署知情同意书后进入临床研究。 （2）受试者临床治疗 1）中医组治疗方案：予消癜通络方，方药组成：水牛角、生地黄、赤芍、牡丹皮、紫草、黄芩、连翘、乌梅、生甘草、雷公藤。根据皮疹评分标准，分为轻型、重型，分别采用不同剂量的雷公藤颗粒进行干预，总疗程共4周。 雷公藤配方颗粒：江阴天江药业有限公司，每袋0.5g（相当于中药饮片10mg），代号11081443。分为轻、重两组，分别用0.3mg/kg、0.5mg/kg进行治疗，总疗程4周。 2）西医组治疗方案：氯雷他定+维生素C（或+泼尼松），疗程共4周。 A.轻型：皮疹评分0～29分，采用氯雷他定+维生素C进行干预； B.重型：皮疹评分≥30分，采用氯雷他定+维生素C+醋酸泼尼松片进行干预 ①氯雷他定片（开瑞坦，规格：10mg/片×6片，拜耳医药上海股份有限公司，国药准字H10970410）。用法用量：12岁以上的儿童，每次10mg，日1次；2～12岁儿童，体重＞30kg，每次10mg，日1次；体重≤30kg，每次5mg，日1次。 ②维生素C片（规格：100mg/片×100片，华南药业有限公司，国药准字H44020774）。用法用量：100mg～300mg/kg?d。 ③醋酸泼尼松片： 浙江仙琚制药有限公司，每片5mg，符合GMP标准，国药准字号H33021207。西医组重型者（皮疹评分40分及以上）予泼尼松片1mg/kg/d进行口服，分3次，3天后改为晨起顿服，2天减5mg，直至减停，最大量不超过80mg。 （3）标本的收集 在研究对象知情同意的情况下，收集入组患儿0～4周血尿常规、24小时尿蛋白定量、肝肾功及治 疗0周、4周免疫六项结果。 （4）统计分析 结果采用SPSS23.0软件进行统计分析。计数资料以频数、百分比表示；计量资料选用均数±标准差（x±s ）表示；计数资料用χ2检验和Fisher确切概率法统计；计量资料符合正态分布及方差齐性时，两组间选用两独立样本t检验，多组间选用单因素方差分析，多组间两两比较选用LSD-t检验；计量资料不符合正态分布及方差齐性时，两组间选用Mann-Whitney U秩和检验，多组间选用Kruskal-Wallis H秩和检验，多组间两两比较选用Dunn or Dunn-Bonferroni post hoc method检验。 （5）结局指标 1）疗效指标：①主要疗效指标：皮疹疗效（包括皮疹消退时间、皮疹消退数量、皮疹复发次数）；②次要疗效指标：全身症状缓解情况（中医症状量化积分），治疗0～4周各记录一次。 2）检查指标：0～4周检测血常规、尿常规、24小时检四项、肝肾功；治疗0周、4周免疫六项水平。 3）安全指标：每周观察患儿的白细胞、肝酶、消化道症状（腹痛、恶心、呕吐、腹泻等）、生殖系统症状（女性患儿月经情况）。

Description for medicine or protocol of treatment in detail：

Research content and design scheme This study used a prospective research method to observe the effect of Xiaodian Tongluo Recipe on the clinical efficacy and adverse reactions of HSP children. Outpatients and inpatients aged 2 ~ 18 years old with recurrent HSP of non nephritic type with syndrome differentiation of blood heat syndrome in the pediatric ward of the First Affiliated Hospital and the Second Affiliated Hospital of Henan University of traditional Chinese medicine and Zhengzhou people's hospital were selected as the research objects. They were randomly divided into traditional Chinese Medicine group and Western medicine group. The traditional Chinese medicine group was treated with Xiaodian Tongluo formula, and the western medicine group was treated with loratadine + prednisone. The children in the two groups were treated for 4 weeks and followed up for 3 months, The efficacy of rash and the remission of systemic symptoms were evaluated every week, the adverse reactions were observed, the recurrence rate and the incidence of renal damage were counted, and the six index levels of hematuria routine, 24-hour urinary protein, liver and kidney function and immunity at 0 and 4 weeks were detected for statistical analysis. Experimental methods and steps (1) Subject recruitment and grouping Using the screening method of outpatient and inpatient medical records, 60 HSP children with syndrome differentiation of wind heat injuring collaterals and blood heat reckless behavior were recruited. They were randomly divided into Xiaodian Tongluo group (30 cases) and Western medicine group (15 cases of light and 15 cases of heavy), registered the subject information, signed the informed consent and entered the clinical study. (2) Clinical treatment of subjects 1) The treatment scheme of TCM group: Xiaodian Tongluo formula, which is composed of buffalo horn, Rehmannia glutinosa, red peony, peony bark, Arnebia, Scutellaria baicalensis, Forsythia suspensa, black plum, raw licorice and Tripterygium wilfordii. According to the scoring standard of rash, it was divided into light and heavy. Different doses of Tripterygium wilfordii granules were used for intervention. The total course of treatment was 4 weeks. A. Mild: the rash score was 0 ~ 29. The intervention was carried out with Tripterygium wilfordii granule 0.3mg/kg ? D, and the maximum amount was no more than 50g; B. Severe: rash score ≥ 30, intervention with Tripterygium wilfordii granule 0.5mg/kg ? D, the maximum amount shall not exceed 50g; Tripterygium wilfordii formula granules: Jiangyin Tianjiang Pharmaceutical Co., Ltd., 0.5g per bag (equivalent to 10mg of traditional Chinese medicine decoction pieces), code 11081443. They were divided into light and heavy groups and treated with 0.3mg/kg and 0.5mg/kg respectively for a total course of 4 weeks. 2) Western medicine group: loratadine + vitamin C (or + prednisone), the course of treatment was 4 weeks. A. Mild: rash score was 0 ~ 29, and loratadine + vitamin C was used for intervention; B. Severe: rash score ≥ 30, with loratadine + vitamin C + prednisone acetate tablets for intervention ① Loratadine Tablets (kairuitan, specification: 10mg / tablet) × 6 tablets, Bayer pharmaceutical Shanghai Co., Ltd., gyzz h10970410). Usage and dosage: children over 12 years old, 10mg each time, once a day; Children aged 2 ~ 12 years old, weight > 30kg, 10mg each time, once a day; Weight ≤ 30kg, 5mg each time, once a day. ② Vitamin C tablets (specification: 100mg / tablet) × 100 tablets, South China Pharmaceutical Co., Ltd., gyzz h44020774). Usage and dosage: 100mg ~ 300mg / kg ? D. ③ Prednisone acetate tablets: Zhejiang Xianju Pharmaceutical Co., Ltd., 5mg per tablet, in line with GMP standard, national drug approval No. h33021207. The severe patients in the western medicine group (rash score 40 and above) were given prednisone tablets 1mg / kg / D orally, divided into three times, changed to take it in the morning after three days, reduced 5mg in two days until it was reduced and stopped, and the maximum amount was no more than 80mg. (3) Collection of specimens With the informed consent of the subjects, the routine blood and urine, 24-hour urinary protein, liver and kidney function and treatment of the enrolled children were collected Six immune results were obtained after 0 and 4 weeks of treatment. (4) Statistical analysis Results spss23.0 software was used for statistical analysis. Counting data are expressed in frequency and percentage; The measurement data shall be expressed as mean ± standard deviation (x ± s); For counting data χ 2 test and Fisher exact probability statistics; When the measurement data conform to the normal distribution and homogeneity of variance, two independent sample t-test is selected between the two groups, one-way ANOVA is selected between multiple groups, and LSD-t test is selected for pairwise comparison between multiple groups; When the measurement data do not conform to the normal distribution and homogeneity of variance, Mann Whitney U rank sum test is used between the two groups, Kruskal Wallis h rank sum test is used between multiple groups, and Dunn or Dunn Bonferroni post hoc method is used for pairwise comparison between multiple groups. (5) Outcome indicators 1) Efficacy indicators: ① main efficacy indicators: rash efficacy (including rash regression time, rash regression number and rash recurrence times); ② Secondary efficacy indicators: remission of systemic symptoms (quantitative score of TCM symptoms), recorded once every 0 ~ 4 weeks. 2) Examination indexes: blood routine examination, urine routine examination, 24-hour examination and liver and kidney function were detected in 0 ~ 4 weeks; Six immune levels were observed at 0 and 4 weeks after treatment. 3) Safety indicators: observe the children's leukocytes, liver enzymes, gastrointestinal symptoms (abdominal pain, nausea, vomiting, diarrhea, etc.) and reproductive system symptoms (menstruation of female children) every week.

纳入标准：

1）符合反复过敏性紫癜的入选标准； 2）皮疹评分≥14分； 3）中医辨证分型属于血热妄行者； 4）2周≤病程≤1年； 5）3岁≤年龄≤16岁； 6）患儿及其家属同意并签署知情同意书。

Inclusion criteria

1) Meet the inclusion criteria of recurrent Henoch Schonlein purpura; 2) Rash score ≥ 14; 3) The syndrome differentiation of traditional Chinese medicine belongs to reckless behavior of blood heat; 4) 2 weeks ≤ course ≤ 1 year; 5) 3 ≤ 16 years old; 6) The children and their families agreed and signed the informed consent form.

排除标准：

1）伴有其他顽固性变态反应性疾病，如顽固性荨麻疹或湿疹； 2）伴有严重消化道症状或肾脏损伤表现者； 3）合并其他脏器损害或伴有精神、神经系统、造血系统疾病等。

Exclusion criteria：

1) Accompanied by other intractable allergic diseases, such as intractable urticaria or eczema; 2) Accompanied by severe gastrointestinal symptoms or renal injury; 3) Combined with other organ damage or accompanied by mental, nervous system and hematopoietic system diseases.

研究实施时间：

Study execute time：

从From 2021-01-01

至To      2022-12-31

征募观察对象时间：

Recruiting time：

从From 2021-09-15

至To      2022-06-30

干预措施：

Interventions：

组别：

中医组

样本量：

30

Group：

TCM group

Sample size：

干预措施：

消癜通络方

干预措施代码：

Intervention：

Xiaodian Tongluo Recipe

Intervention code：

组别：

对照组

样本量：

30

Group：

control group

Sample size：

干预措施：

中药模拟剂+氯雷他定+维生素C+泼尼松片

干预措施代码：

Intervention：

Chinese medicine simulant + loratadine + vitamin C + prednisone tablets

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)：

河南

市(区县)：

郑州市

Country：

China

Province：

Henan

City：

Zhengzhou

单位(医院)：

河南中医药大学第一附属医院

单位级别：

三级甲等

Institution/hospital：

The First Affiliated Hospital of Henan University of traditional Chinese Medicine

Level of the institution：

Class III class A

测量指标：

Outcomes：

指标中文名：

皮疹疗效

指标类型：

主要指标

Outcome：

Rash efficacy

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

免疫六项

指标类型：

次要指标

Outcome：

Six immune items

Type：

Secondary indicator

测量时间点：

4 周

测量方法：

Measure time point of outcome：

4 week

Measure method：

指标中文名：

尿常规

指标类型：

次要指标

Outcome：

urinalysis

Type：

Secondary indicator

测量时间点：

4周

测量方法：

Measure time point of outcome：

4 week

Measure method：

指标中文名：

肝功能

指标类型：

次要指标

Outcome：

liver function

Type：

Secondary indicator

测量时间点：

4周

测量方法：

Measure time point of outcome：

4 week

Measure method：

指标中文名：

肾功能

指标类型：

次要指标

Outcome：

renal function

Type：

Secondary indicator

测量时间点：

4周

测量方法：

Measure time point of outcome：

4 week

Measure method：

指标中文名：

血常规

指标类型：

次要指标

Outcome：

routine blood test

Type：

Secondary indicator

测量时间点：

4周

测量方法：

血液

Measure time point of outcome：

4 week

Measure method：

blood

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：

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：

征募研究对象情况：

尚未开始

Not yet recruiting

年龄范围：

最小 岁
Min age years
最大 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）：

按就诊序列，随机数字表法

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

By visit sequence, random number table method

盲法：

Blinding：

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）：

-

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：

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：

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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