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A randomized, double-blind, placebo-parallel controlled, multicenter Phase III clinical trial of efficacy and safety of Xiao'er Huangjin Zhike Granules in the treatment of acute bronchitis cough&#

Registration number：

ITMCTR2200005488

Date of Last Refreshed on：

2022-01-03

Date of Registration：

2022-01-03

Registration Status：

Prospective registration

Public title：

A randomized, double-blind, placebo-parallel controlled, multicenter Phase III clinical trial of efficacy and safety of Xiao'er Huangjin Zhike Granules in the treatment of acute bronchitis cough&#

English Acronym：

Scientific title：

A randomized, double-blind, placebo-parallel controlled, multicenter Phase III clinical trial of efficacy and safety of Xiao'er Huangjin Zhike Granules in the treatment of acute bronchitis cough&#

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

ChiCTR2200055211 ; ChiMCTR2200005488

Applicant：

Hongtu Wang

Study leader：

Baoping XU

Applicant telephone：

13522058311

Study leader's telephone：

13370115002

Applicant Fax：

Study leader's fax：

Applicant E-mail：

wanghongtu@bj-dfyj.com

Study leader's E-mail：

xubaopingbch@163.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

801, zhuzongdichandasha Building, No.2 Building, Huixin East Street, Chaoyang District, Beijing

Study leader's address：

56 Nanlishi Road, Xicheng District, Beijing

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Beijing Dongfangyunjia Science&Technology Co.,Ltd

Approved by ethic committee：

Approved No. of ethic committee：

Approved file of Ethical Committee：

Name of the ethic committee：

Date of approved by ethic committee：

2013/8/26 0:00:00

Contact Name of the ethic committee：

Contact Address of the ethic committee：

Contact phone of the ethic committee：

Contact email of the ethic committee：

Primary sponsor：

Beijing Children's Hospital，Capital Medical University

Primary sponsor's address：

56 Nanlishi Road, Xicheng District, Beijing

Secondary sponsor：

Country：

China

Province：

Beijing

City：

Chaoyang

Institution
hospital：

Beijing Dongfangyunjia Science&Technology Co.,Ltd

Address：

801, zhuzongdichandasha Building, No.2 Building, Huixin East Street, Chaoyang District, Beijing

Source(s) of funding：

Beijing Dongfangyunjia Science&Technology Co.,Ltd

Target disease：

Acute bronchitis cough in children

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Phase III clinical trial

Objectives of Study：

To evaluate the effectiveness of Xiao'er Huangjin Zhike Granules in the treatment of acute bronchitis cough (syndrome of phlegm heat obstructing lung) in children. To evaluate the safety of Xiao'er Huangjin Zhike Granules in the treatment of children with acute bronchitis cough (syndrome of phlegm heat obstructing lung).

Description for medicine or protocol of treatment in detail：

Inclusion criteria

Inclusion criteria: (1) Consistent with the diagnosis of acute bronchitis in children; (2) TCM syndrome differentiation is syndrome of phlegm heat obstructing lung; (3) Aged between 3 and 7 (including 3 and 7 years old), regardless of gender; (4) Cough symptom score ≥2 points in daytime or ≥2 points in night; (5) Within 72 hours after the onset of acute bronchitis, no drugs with antitussive and expectorant effects or other treatments were used before treatment (except for those who only used once or twice and no drugs were used within 12 hours); (6) The legal guardians of the children agreed that their children should participate in the study and sign the informed consent.

Exclusion criteria：

Exclusion criteria: (1) The highest body temperature within 24 hours before enrollment & GT; Children at 38.5℃; (2) children with measles, whooping cough, influenza and other acute infectious diseases; (3) children with acute upper respiratory tract infection, bronchial asthma, bronchiolitis, asthmatic bronchitis, bronchopneumonia and other respiratory diseases; (4) Children allergic to the test drug or its ingredients; (5) children with malnutrition, immune deficiency and tuberculosis; (6) Children who have participated in or are participating in clinical trials of other drugs within 1 month; (7) children with serious primary diseases such as heart, liver, kidney, digestive and hematopoietic system; (8) The researchers identified children who were not suitable for clinical trials.

Study execute time：

From 2021-06-10

To      2022-12-31

Recruiting time：

From 2022-01-03

To      2022-06-30

Interventions：

90

Group：

control group

Sample size：

Intervention：

take Xiao'er Huangjin Zhike Granules placebo

Intervention code：

270

Group：

treatment group

Sample size：

Intervention：

take Xiao'er Huangjin Zhike Granules

Intervention code：

Total sample size ： 360

Countries of recruitment
and research settings：

Country：

China

Province：

Anhui

City：

Hefei

Institution/hospital：

The Second Affiliated Hospital of Anhui Medical University

Level of the institution：

tertiary

Country：

China

Province：

Henan

City：

Zhengzhou

Institution/hospital：

Zhengzhou Children's Hospital

Level of the institution：

Third rate

Country：

China

Province：

Henan

City：

Sanmenxia

Institution/hospital：

Sanmenxia Central Hospital

Level of the institution：

Third rate

Country：

China

Province：

Beijing

City：

Xicheng

Institution/hospital：

Beijing Children's Hospital，Capital Medical University

Level of the institution：

Third rate

Country：

China

Province：

Jiangxi

City：

Nanchang

Institution/hospital：

The Third Hospital Of Nanchang

Level of the institution：

tertiary

Country：

China

Province：

Heilongjiang

City：

Harbin

Institution/hospital：

First Affiliated Hospital,Heilongjiang University of Chinese Medicine

Level of the institution：

tertiary

Country：

China

Province：

Yunnan

City：

Kunming

Institution/hospital：

Kunming Children's Hospital

Level of the institution：

Third rate

Country：

China

Province：

Anhui

City：

Hefei

Institution/hospital：

The Fourth Affiliated Hospital of Anhui Medical University

Level of the institution：

tertiary

Country：

China

Province：

Jiangsu

City：

Wuxi

Institution/hospital：

Wuxi No.8 People's Hospital Group

Level of the institution：

comprehensive Grade 2A

Country：

China

Province：

Hunan

City：

Changsha

Institution/hospital：

The First Hospital of Hunan University of Chinese Medicine

Level of the institution：

tertiary

Country：

China

Province：

Jiangsu

City：

Wuxi

Institution/hospital：

Wuxi Children's Hospital

Level of the institution：

tertiary

Country：

China

Province：

Jiangxi

City：

Pingxiang

Institution/hospital：

Jiangxi Pingxiang People's Hospital

Level of the institution：

tertiary

Country：

China

Province：

Chongqing

City：

Jiangjin

Institution/hospital：

Jiangjin Central Hospital Of Chongqing

Level of the institution：

tertiary

Country：

China

Province：

Jilin

City：

Yanbian

Institution/hospital：

Yanbian University Hospital（Yanbian Hospital）

Level of the institution：

tertiary

Country：

China

Province：

Guangdong

City：

Guangzhou

Institution/hospital：

Zhujiang Hospital Of Southern Medical University

Level of the institution：

Third rate

Country：

China

Province：

Yunnan

City：

Kunming

Institution/hospital：

Yunnan Provincial Hospital of Traditional Chinese Medicine

Level of the institution：

tertiary

Country：

China

Province：

Hubei

City：

Wuhan

Institution/hospital：

People's Hospital of Wuhan University

Level of the institution：

tertiary

Country：

China

Province：

Zhejiang

City：

Jiaxing

Institution/hospital：

The First Hospital Of Jiaxing

Level of the institution：

Third rate

Country：

China

Province：

Shandong

City：

Zaozhuang

Institution/hospital：

Zaozhuang Municipal Hospital

Level of the institution：

Third rate

Country：

China

Province：

Jiangsu

City：

Huaian

Institution/hospital：

Huai 'an First People's Hospital

Level of the institution：

tertiary

Country：

China

Province：

Guangdong

City：

Zhongshan

Institution/hospital：

Boai Hospital Of Zhongshan

Level of the institution：

tertiary

Country：

China

Province：

Hunan

City：

Shaoyang

Institution/hospital：

The First Affiliated Hospital of Shaoyang University

Level of the institution：

Third rate

Country：

China

Province：

Shandong

City：

Jining

Institution/hospital：

Affiliated Hospital of Jining Medical University

Level of the institution：

tertiary

Outcomes：

Outcome：

Cough severity-time area under the curve

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Routine blood

Type：

Adverse events

Measure time point of outcome：

Measure method：

Outcome：

Cough onset time

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Evaluation of sputum viscosity

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

12-lead ECG

Type：

Adverse events

Measure time point of outcome：

Measure method：

Outcome：

renal function

Type：

Adverse events

Measure time point of outcome：

Measure method：

Outcome：

Routine urine

Type：

Adverse events

Measure time point of outcome：

Measure method：

Outcome：

Cough disappear/almost disappear time

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Phlegm symptom score

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

estradiol

Type：

Adverse events

Measure time point of outcome：

Measure method：

Outcome：

Rate of cough disappearance/basic disappearance after 7 days of treatment.

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Vital signs

Type：

Adverse events

Measure time point of outcome：

Measure method：

Outcome：

Liver function

Type：

Adverse events

Measure time point of outcome：

Measure method：

Outcome：

Physical check

Type：

Adverse events

Measure time point of outcome：

Measure method：

Outcome：

Adverse event Record

Type：

Adverse events

Measure time point of outcome：

Measure method：

Outcome：

TCM syndrome effect

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

urine

Tissue：

Fate of sample 

Destruction after use

Note：

Sample Name：

blood

Tissue：

Fate of sample 

Destruction after use

Note：

Not yet recruiting

3
Min age years
7
Max age years

Recruiting status：

Participant age：

Gender：

Both

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

This study adopted block randomization method, in which each center competed to be enrolled. Subjects in each block group came from the same research center, and the children were randomly assigned to the experimental group or placebo group in a ratio of 3:1. The biostatistics department commissioned by this&#

Blinding：

IPD sharing：

Yes

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

Raw data is not shared

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

This study uses Electronic Data Capture, EDC。

Data Managemen Committee：

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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