Register Now
Log In
中文/English
About ITMCTR|Search Trials|About Us|News
The clinical standardization study on the treatment of spleen deficiency syndrome after repeated respiratory tract infection by the method of cultivating earth to generate gold

注册号：

Registration number：

ITMCTR2100004923

最近更新日期：

Date of Last Refreshed on：

2021-06-08

注册时间：

Date of Registration：

2021-06-08

注册号状态：

Registration Status：

补注册

Retrospective registration

注册题目：

培土生金法治疗小儿反复呼吸道感染后脾虚综合征临床规范化研究

Public title：

The clinical standardization study on the treatment of spleen deficiency syndrome after repeated respiratory tract infection by the method of cultivating earth to generate gold

注册题目简写：

English Acronym：

研究课题的正式科学名称：

培土生金法治疗小儿反复呼吸道感染后脾虚综合征临床规范化研究

Scientific title：

The clinical standardization study on the treatment of spleen deficiency syndrome after repeated respiratory tract infection by the method of cultivating earth to generate gold

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：

15401970800

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：

ChiCTR2100047128 ; ChiMCTR2100004923

申请注册联系人：

李华

研究负责人：

李华

Applicant：

Li Hua

Study leader：

Li Hua

申请注册联系人电话：

Applicant telephone：

+86 021-5296581

研究负责人电话：

Study leader's telephone：

+86 021-5296581

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：

drlihua502@126.com

研究负责人电子邮件：

Study leader's E-mail：

drlihua502@126.com

申请单位网址(自愿提供)：

Study leader's website(voluntary supply)：

http://www.shchildren.com.cn/

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：

上海市北京西路1400弄24号

研究负责人通讯地址：

上海市北京西路1400弄24号

Applicant address：

24 1400th Lane, Beijing Road West, Shanghai, China

Study leader's address：

24 1400th Lane, Beijing Road West, Shanghai, China

申请注册联系人邮政编码：

Applicant postcode：

200040

研究负责人邮政编码：

Study leader's postcode：

200040

申请人所在单位：

上海市儿童医院

Applicant's institution：

Children's Hospital of Shanghai

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：

2015R017-F02

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：

上海市儿童医院伦理委员会

Name of the ethic committee：

Shanghai Children's Hospital Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

2015/11/23 0:00:00

伦理委员会联系人：

奚益群

Contact Name of the ethic committee：

Xi Yiqun

伦理委员会联系地址：

上海市北京西路1400弄24号

Contact Address of the ethic committee：

24 1400th Lane, Beijing Road West, Shanghai, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 21 52976581

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：

上海市儿童医院

Primary sponsor：

Children's Hospital of Shanghai

研究实施负责（组长）单位地址：

上海市北京西路1400弄24号

Primary sponsor's address：

24 1400th Lane, Beijing Road West, Shanghai, 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)：

上海

市(区县)：

Country：

China

Province：

Shanghai

City：

单位(医院)：

上海市儿童医院

具体地址：

北京西路1400弄24号

Institution
hospital：

Children's Hospital of Shanghai

Address：

24 1400th Lane, Beijing Road West

经费或物资来源：

上海市科学技术委员会

Source(s) of funding：

Shanghai Municipality's three-year action plan for further accelerating the development of Chinese medicine

研究疾病：

小儿反复呼吸道感染后脾虚综合征

研究疾病代码：

Target disease：

Spleen deficiency syndrome after recurrent respiratory tract infection in children

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：

观察加味人参五味子汤对脾虚证患儿反复呼吸道感染后血清微量元素及免疫功能的影响。

Objectives of Study：

To observe the effect of Modified Ginseng-Schisandra Decoction on serum trace elements and immune function in children with spleen deficiency syndrome after recurrent respitatory tract infection.

药物成份或治疗方案详述：

资料与方法 本试验研究经上海市儿童医院（上海交通大学附属儿童医院）伦理委员会讨论通过。 1 病例选择 (1)纳入标准 1)小儿反复呼吸道感染的诊断符合中华医学会儿科学分会制定的有关标准； 2)中医脾虚综合征诊断符合相关文献标准； 3)年龄1～12岁，性别不限； 4)患儿家属知情同意。 (2)排除标准 1)合并心、脑、肝、肾和造血系统等严重疾病者； 2)肺结核、支气管异物、先天性疾病等原因引起的反复呼吸道感染者； 3)伴有精神疾病者。 2 一般资料 本研究共纳入2019年6月-2020年5月就诊于上海市儿童医院中医科的80例反复呼吸道感染后脾虚综合征患儿，随机分为观察组和对照组，每组均40例。其中，观察组中男性23例、女性17例，年龄3~12岁，平均（6.50±2.81）岁；对照组中男性28例、女性12例，年龄3~12岁，平均（6.83±2.26）岁。两组患儿基线资料的差异无统计学意义（P均＞0.05），具有可比性。 3 治疗方法 对照组患儿予枯草杆菌二联活菌颗粒（妈咪爱，北京韩美药品有限公司，批准文号：国药准字30002270S）治疗。用法用量：2周岁以下，每次1袋，每天1～2次，温开水冲服；2周岁以上，每次1～2袋，每天1～2次，温开水冲服。疗程为4周。 治疗组患儿给予加味人参五味子汤治疗。基础方：黄芪6g、党参6 g、白术6 g、白茯苓9 g、五味子3 g、麦冬6 g、牡蛎15g、炙甘草3g。患儿服用的加味人参五味子汤系中药免煎配方颗粒剂（江阴天江药业有限公司生产），用法如下：1 ~ 2岁，2次/d、1/3剂/次；3 ~ 6岁，2次/d、0.5剂/次；＞6岁，2次/d、1剂/次。餐后温水冲服，疗程4周。 4 观察项目与疗效评价标准 (1)中医证候积分 分别于治疗前后，采用计分法观察中医证候情况。主症（食少纳呆，恶心呕吐，汗多乏力，大便溏薄）按无、轻、中、重分别计0分、2分、4分、6分。 (2)临床疗效 疗程结束后，参照《中药新药临床研究指导原则》中的有关标准效判定临床疗效 1) 临床痊愈：中医证候积分减少≥95%； 2) 显效：中医证候积分减少≥70%； 3) 有效：中医证候积分减少≥30%； 4) 无效：中医证候积分减少＜30%。 (3)实验室指标 分别于治疗前后检测患儿的血清免疫球蛋白、T淋巴细胞亚群和微量元素指标。 5 统计学方法 采用SPSS 21.0软件对本研究数据进行统计学分析。计量资料用均数±标准差（±s）表示，采用t检验；等级资料采用秩和检验。P＜0.05表示差异具有统计学意义。

Description for medicine or protocol of treatment in detail：

1 Data and Methods This study was discussed and approved by the ethics committee of Shanghai Children's Hospital (children's Hospital Affiliated to Shanghai Jiaotong University). 1. Case selection (1)Inclusion criteria 1) The diagnosis of children's recurrent respiratory tract infection was in accordance with the relevant standards formulated by the scientific branch of Chinese Medical Association [7]; 2) The diagnosis of spleen deficiency syndrome in traditional Chinese medicine was in accordance with the relevant literature standards [4]; 3) the age was 1-12 years old, regardless of gender; 4) The family members of the patients gave informed consent. (2)Exclusion criteria 1)Patients with serious diseases such as heart, brain, liver, kidney and hematopoietic system; 2)Patients with repeated respiratory infections caused by tuberculosis, foreign bodies in the bronchus, congenital diseases, etc.; 3)Patients with mental illness. 2. General information A total of 80 children with spleen deficiency syndrome after repeated respiratory infections who were admitted to the Department of Traditional Chinese Medicine of Shanghai Children's Hospital from June 2019 to May 2020 were included in this study. They were randomly divided into observation group and control group, with 40 cases in each group. Among them, there were 23 males and 17 females in the observation group, aged 3-12 years old, with an average of (6.50±2.81) years old; 28 males and 12 females in the control group, aged 3-12 years old, with an average of (6.83±2.26) year old. The difference in baseline data between the two groups of children was not statistically significant (P>0.05), and they were comparable. 3. Treatment methods Children in the control group were treated with Combined Bacillus Subtilis and Enterococcus Faecium Granules with Multivitamines,Live (Mamiai, Beijing Hanmei Pharmaceutical Co., Ltd., approval number: National Medicine Standard 30002270S). Usage and dosage: 1 bag each time, 1 or 2 times a day, with warm water for under 2 years old; 1 or 2 bags each time, 1 or 2 times a day, with warm water for more than 2 years old. The course of treatment is 4 weeks. Children in the treatment group were treated with Modified Ginseng-Schisandra Decoction .The basic prescription is composed of Radix astragali(6g)Codonopsis pilosula(6g) Atractylodes macrocephala Koidz.(6g) Poria cocos(9g) Schisandra(3g) Ophiopogon japonicus(6g)oyster(15g) Radix Glycyrrhizae Preparate(3g)Saposhnikovia divaricata(10g) and it should be added or subtracted based on clinical symptoms.The Modified Ginseng-Schisandra Decoction for children is a traditional Chinese medicine decoction-free granule (produced by Jiangyin Tianjiang Pharmaceutical Co., Ltd.). The usage is as follows: 1 to 2 years old, 2 times/d, 1/3 doses/time; 3 to 6 years old , 2 times/d, 0.5 dose/time;> 6 years old, 2 times/d, 1 dose/time. Take it with boiling water after a meal for 4 weeks. 4. Observation items and efficacy evaluation standards (1) TCM syndrome scores Before and after treatment, a scoring method is used to observe the TCM syndromes. The main symptoms (lack of food and appetite, nausea and vomiting, excessive sweating and fatigue, loose stools) are scored as 0, 2, 4, and 6 points according to no, mild, moderate, and severe. (2) Clinical efficacy After the course of treatment, refer to the relevant standard efficacy in the "Guiding Principles for Clinical Research of New Chinese Medicines" to determine the clinical efficacy. 1) Clinical recovery: TCM syndrome score reduction >= 95%; 2) Significant effect: TCM syndrome score reduction >= 70%; 3) Effective: TCM syndrome score reduction >= 30%; 4) Ineffective: TCM syndrome score reduction < 30%. (3) Laboratory indicators Test the children's serum immunoglobulin, T lymphocyte subsets and trace element indicators before and after treatment. 5. Statistical methods SPSS 21.0 software was used for statistical analysis of the data in this study. Measurement data are expressed as mean ± standard deviation (±s), using t test; rank data using rank sum test. P < 0.05 indicates that the difference is statistically significant.

纳入标准：

1.患儿反复呼吸道感染的诊断依据中华医学会科学分会制定的相关标准; 2.中医对脾虚证的诊断符合相关文献标准; 3.年龄1 ~ 12岁，不分性别; 4.患者家属给予知情同意。

Inclusion criteria

1. The diagnosis of children's recurrent respiratory tract infection was in accordance with the relevant standards formulated by the scientific branch of Chinese Medical Association ; 2. The diagnosis of spleen deficiency syndrome in traditional Chinese medicine was in accordance with the relevant literature standards; 3. Aged 1 to 12 years, regardless of gender; 4. The family members of the patients gave informed consent.

排除标准：

1. 心、脑、肝、肾、造血系统等重大疾病患者； 2. 肺结核、支气管异物、先天性疾病等引起反复呼吸道感染的患者； 3. 精神疾病患者。

Exclusion criteria：

1. Patients with serious diseases such as heart, brain, liver, kidney and hematopoietic system; 2. Patients with repeated respiratory infections caused by tuberculosis, foreign bodies in the bronchus, congenital diseases, etc.; 3. Patients with mental illness.

研究实施时间：

Study execute time：

从From 2015-07-01

至To      2018-09-30

征募观察对象时间：

Recruiting time：

从From 2015-07-01

至To      2018-09-30

干预措施：

Interventions：

组别：

治疗组

样本量：

40

Group：

Treatment group

Sample size：

干预措施：

加味人参五味子汤

干预措施代码：

Intervention：

Modified Ginseng-Schisandra Decoction

Intervention code：

组别：

对照组

样本量：

40

Group：

Control group

Sample size：

干预措施：

枯草杆菌二联活菌颗粒（妈咪爱）

干预措施代码：

Intervention：

Combined Bacillus Subtilis and Enterococcus Faecium Granules with Multivitamines,Live (Mamiai）

Intervention code：

样本总量 Total sample size ： 80

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

上海

市(区县)：

静安区

Country：

China

Province：

Shanghai

City：

Jing'an District

单位(医院)：

上海市儿童医院

单位级别：

三级甲等

Institution/hospital：

Children's Hospital of Shanghai

Level of the institution：

Tertiary A Hospital

测量指标：

Outcomes：

指标中文名：

血清免疫球蛋白

指标类型：

主要指标

Outcome：

serum immunoglobulin

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

T淋巴细胞亚群

指标类型：

主要指标

Outcome：

T lymphocyte subsets

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

中医证候积分

指标类型：

主要指标

Outcome：

TCM syndrome scores

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

微量元素

指标类型：

主要指标

Outcome：

trace element indicators

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

临床疗效

指标类型：

主要指标

Outcome：

Clinical efficacy

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：

血清

组织：

Sample Name：

serum

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：

结束

Completed

年龄范围：

最小 3 岁
Min age years
最大 12 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）：

将患儿随机化进行分组，分配至治疗组与对照组，采用随机数字表进行编号。

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

The children were randomly divided into treatment group and control group, and numbered with random number table.

盲法：

Not stated

Blinding：

Not stated

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）：

试验完成后6个月内公开原始数据，可经过邮箱索取，邮箱为：drlihua502@126.com

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

Within 6 months after the completion of the test, the original data can be obtained through the email: drlihua502@126.com

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：

电子采集和管理系统(Electronic Data Capture, EDC)。

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

Electronic Data Capture, EDC

数据管理委员会：

Data Managemen Committee：

暂未确定

Not yet

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):

back
Platform information
About ITMCTR
About Us
Register Trials
Frequently Asked Questions
Ethical Review
The public service
Search Trials
Join Us
ITMCTR BJ-ICP:07032215-5 Tip: IE8 is recommended Use the system with widescreen display resolution above