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清宣止咳颗粒治疗儿童支原体感染性支气管炎的临床研究

注册号：

Registration number：

ITMCTR2025001306

最近更新日期：

Date of Last Refreshed on：

2025-06-30

注册时间：

Date of Registration：

2025-06-30

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

清宣止咳颗粒治疗儿童支原体感染性支气管炎的临床研究

Public title：

Clinical research on the treatment of mycoplasma infectious bronchitis in children with Qingxuan Zhike Granules

注册题目简写：

English Acronym：

研究课题的正式科学名称：

清宣止咳颗粒治疗儿童支原体感染性支气管炎的临床研究

Scientific title：

Clinical research on the treatment of mycoplasma infectious bronchitis in children with Qingxuan Zhike Granules

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：

林一辰

研究负责人：

吴振起

Applicant：

Yichen Lin

Study leader：

Zhenqi Wu

申请注册联系人电话：

Applicant telephone：

15194238907

研究负责人电话：

Study leader's telephone：

18102456617

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：

15194238907@163.com

研究负责人电子邮件：

Study leader's E-mail：

zhenqiwu@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：

辽宁省沈阳市皇姑区崇山东路79号辽宁中医药大学

研究负责人通讯地址：

辽宁省沈阳市皇姑区黄河北大街60号辽宁中医药大学附属第二医院

Applicant address：

No. 79 Chongshan East Road Huanggu District Shenyang City Liaoning Province Liaoning University of Traditional Chinese Medicine

Study leader's address：

The Second Affiliated Hospital of Liaoning University of Traditional Chinese Medicine No. 60 North Huanghe Street Huanggu District Shenyang City Liaoning 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：

辽宁省沈阳市皇姑区崇山东路79号辽宁中医药大学

Applicant's institution：

No. 79 Chongshan East Road Huanggu District Shenyang City Liaoning Province Liaoning 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：

2025(KT)-005-02(FS)

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：

辽宁中医药大学附属第二医院伦理委员会

Name of the ethic committee：

IEC of the Second Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

2025/4/25 0:00:00

伦理委员会联系人：

慕杨娜

Contact Name of the ethic committee：

Yangna Mu

伦理委员会联系地址：

辽宁省沈阳市皇姑区黄河北大街60号 辽宁中医药大学附属第二医院 国家药物临床试验中心（求新楼）5楼 伦理委员会办公室

Contact Address of the ethic committee：

Office of the Ethics Committee 5th Floor National Center for Clinical Trials of Drugs (Qiu Xin Building) the Second Affiliated Hospital of Liaoning University of Traditional Chinese Medicine No. 60 North Huanghe Street Huanggu District Shenyang City Liaoning Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

024-86803333-8505

伦理委员会联系人邮箱：

Contact email of the ethic committee：

llbgs2011@126.com

研究实施负责（组长）单位：

辽宁中医药大学附属第二医院

Primary sponsor：

The Second Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

研究实施负责（组长）单位地址：

辽宁省沈阳市皇姑区黄河北大街60号辽宁中医药大学附属第二医院

Primary sponsor's address：

The Second Affiliated Hospital of Liaoning University of Traditional Chinese Medicine No. 60 North Huanghe Street Huanggu District Shenyang City Liaoning 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)：

辽宁

市(区县)：

沈阳市

Country：

China

Province：

Liaoning

City：

Shenyang

单位(医院)：

辽宁中医药大学附属第二医院

具体地址：

辽宁省沈阳市皇姑区黄河北大街60号辽宁中医药大学附属第二医院

Institution
hospital：

The Second Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

Address：

The Second Affiliated Hospital of Liaoning University of Traditional Chinese Medicine No. 60 North Huanghe Street Huanggu District Shenyang City Liaoning Province

经费或物资来源：

世界中医药科技专项——清宣止咳颗粒治疗儿童支原体感染性支气管炎的临床研究WFCMS2024053

Source(s) of funding：

World Traditional Chinese Medicine Science and Technology Special Project - Clinical Research on Qingxuan Zhike Granules in the Treatment of Mycoplasma Infectious Bronchitis in Children WFCMS2024053

研究疾病：

支原体感染性支气管炎

研究疾病代码：

Target disease：

Mycoplasma infectious bronchitis

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：

上市后药物

Post-marketing clinical trial

研究目的：

评价清宣止咳颗粒治疗儿童支原体感染性支气管炎的有效性和安全性，并进一步开展基础研究。

Objectives of Study：

To evaluate the efficacy and safety of Qingxuan Zhike Granules in the treatment of mycoplasma infectious bronchitis in children and to further conduct basic research.

药物成份或治疗方案详述：

清宣止咳颗粒（国药准字Z19990066）是山东名老中医张珍玉教授应用多年的经验方，由桑叶、薄荷、杏仁、桔梗、白芍、紫菀、积壳、陈皮、甘草组方，具疏风清热、宣肺止咳的功效，于1999年获批上市，属于国家医保甲类、基药品种，对儿童和成人的呼吸道相关疾病均有明显疗效。本研究中清宣止咳颗粒，方中桑叶、薄荷辛凉解表，疏散风热，宣肺止咳，共为君药。苦杏仁、紫菀苦降肺气、消痰止咳；桔梗宣肺祛痰，共为臣药。白芍缓中止痛，敛阴收汗；枳壳理气，使气行则痰化；陈皮燥湿健脾化痰，共为佐药。甘草调和诸药，为使药。诸药合用共奏疏风清热、宣肺止咳之功。现代药理学研究表明清宣止咳颗粒具有止咳化痰、抗炎、调节免疫等药理作用。 课题组采用多中心、随机对照的试验设计，于同城3家三级甲等医院同期开展“清宣止咳颗粒治疗儿童支原体感染性支气管炎的临床研究”，以阿奇霉素联合清宣止咳颗粒干预儿童MPB，整合疾病、中医证候、单症状疗效，并与炎症因子、理化检查等微观指标相结合，评价清宣止咳颗粒对儿童MPB的临床疗效及安全性，以期为MPB的中医药治疗提供循证依据，实现更好的经济效益和社会效益。

Description for medicine or protocol of treatment in detail：

Qingxuan Zhike Granules (National Drug Approval No. Z19990066) is an empirical formula that Professor Zhang Zhenyu a renowned traditional Chinese medicine doctor from Shandong Province has been applying for many years. It is composed of mulberry leaves mint almonds platycodon grandiflorum white peony root Astragalus officinalis accumulated shell dried tangerine peel and licorice. It has the functions of dispelling wind clearing heat promoting lung function and relieving cough. It was approved for marketing in 1999 and is classified as a Class A and essential drug under the national Medical insurance. It has obvious therapeutic effects on respiratory-related diseases in both children and adults. In this study Qingxuan Zhike Granules along with mulberry leaves and mint in the formula are pungent and cool in nature relieving the exterior dispelling wind-heat and promoting lung function to relieve cough. Together they serve as the main medicinal ingredient. Bitter almonds and aster have the effects of lowering lung qi eliminating phlegm and relieving cough. Platycodon grandiflorum promotes lung function and eliminates phlegm and they are both used as the main medicinal herb. White peony root soothes the middle and relieves pain consolidates Yin and stops sweating. Zhike regulates qi. When qi flows smoothly phlegm will transform. Dried tangerine peel dries dampness strengthens the spleen and resolves phlegm and is used as an adjuvant medicine together. Licorice harmonizes various herbs and serves as an active ingredient. The combined use of these herbs has the effect of dispelling wind clearing heat promoting lung function and relieving cough. Modern pharmacological studies have shown that Qingxuan Zhike Granules have pharmacological effects such as relieving cough and expectoration anti-inflammation and regulating immunity. The research group adopted a multicenter randomized controlled trial design to conduct a clinical study on "Qingxuan Zhike Granules in the Treatment of Mycoplasma Infectious Bronchitis in Children" simultaneously in three tertiary grade A hospitals in the same city. They intervened with azithromycin combined with Qingxuan Zhike Granules in children with MPB integrating the disease traditional Chinese medicine syndromes and single-symptom efficacy and combining it with microscopic indicators such as inflammatory factors and physical and chemical examinations. To evaluate the clinical efficacy and safety of Qingxuan Zhike Granules for MPB in children with the aim of providing evidence-based evidence for the traditional Chinese medicine treatment of MPB and achieving better economic and social benefits.

纳入标准：

病例纳入标准 ①咳嗽1～3天； ②符合下述西医诊断及中医辨证标准； ③年龄1～14岁（含两端）； ④知情同意过程应符合规定，法定监护人或与受试儿童（≥8岁）共同签署知情同意书。 西医诊断标准： 参照《诸福棠实用儿科学》（第8版）制定诊断标准如下： ①咳嗽（≤72h），发热，伴或不伴咳痰、咽红不适等症状； ②肺部听诊呼吸音粗糙，或有不固定散在干湿啰音； ③X线肺部无改变，或肺纹理增粗； ④咽拭子MP-DNA检测阳性，或肺炎支原体IgM检测≥1:160。 中医辨证标准： 参照江苏省中西医结合学会儿科专业委员会、中国中西医结合学会儿科专业委员会《儿童急性支气管炎中西医结合诊治专家共识》制定诊断标准如下： 风热犯肺证： 主症：咳嗽、痰黄或白黏，或痰少、咯痰不爽，或干咳； 次症：①鼻塞、流浊涕，或鼻窍干热； ②恶风，有汗，或有发热； ③口干渴； ④咽干，甚则咽痛； 舌尖红，舌苔薄黄或薄白干，脉浮或浮数，或指纹浮紫。 主症必备，次症具备2项，兼具舌脉，即可辨证。

Inclusion criteria

Case inclusion criteria ① Cough for 1 to 3 days; ② Meets the following western medicine diagnosis and Chinese medicine identification criteria; ③ Age 1 to 14 years old (including both ends); ④ The informed consent process should be in accordance with the regulations and the legal guardian or with the subject child (≥8 years old) should sign the informed consent form. Western medical diagnostic criteria: Diagnostic criteria were formulated with reference to Zhufutang Practical Paediatrics (8th edition) as follows: ① Cough (≤72h) fever with or without coughing up sputum red throat discomfort and other symptoms; ② Rough breath sounds on lung auscultation or irregular scattered dry and wet rales; ③X-ray lungs without changes or thickening of lung texture; ④Positive MP-DNA test on pharyngeal swab or Mycoplasma pneumoniae IgM test ≥1:160. Chinese medicine identification criteria: The diagnostic criteria were formulated with reference to the Expert Consensus on Integrated Chinese and Western Medicine Diagnosis and Treatment of Acute Bronchitis in Children by the Paediatrics Specialty Committee of Jiangsu Society of Integrative Medicine and the Chinese Society of Integrative Medicine as follows: Wind-heat offending the lungs evidence: Primary symptoms: cough yellow or white sticky sputum or little sputum unpleasant sputum or dry cough; Secondary symptoms: ① nasal congestion turbid runny nose or dry and hot nasal orifices; ②Bad wind with sweating or fever; ③ Dry mouth and thirst; ④Dry throat or even sore throat; Red tongue tip thin yellow or thin white dry tongue coating floating or floating pulse or floating purple fingerprints. The primary symptom is necessary the secondary symptom has 2 items and both the tongue and pulse can be identified.

排除标准：

病例排除标准 ①MP肺炎或出现多系统、多器官损害者； ②呼吸道存在多种病原菌感染，有其他肺部疾病； ③患严重的肝、肾、心血管及造血系统疾病、免疫系统疾病，以及精神疾病患儿； ④对已知试验药物或组成成分过敏者； ⑤近三个月内参加或正在参加其它药物临床试验的患者； ⑥根据医生判断，无法评价疗效或不可能完成预期疗程和随访的患儿。

Exclusion criteria：

Case exclusion criteria ①MP pneumonia or multi-system and multi-organ damage; ②There are various pathogenic bacteria infections in the respiratory tract and other lung diseases; ③ Children with severe liver kidney cardiovascular and hematopoietic system diseases immune system diseases and mental disorders; ④ Those who are allergic to known test drugs or components; ⑤ Patients who have participated in or are currently participating in clinical trials of other drugs within the past three months; ⑥ Children who based on the doctor's judgment cannot evaluate the therapeutic effect or are unable to complete the expected course of treatment and follow-up.

研究实施时间：

Study execute time：

从From 2025-02-01

至To      2027-02-28

征募观察对象时间：

Recruiting time：

从From 2025-07-10

至To      2026-07-10

干预措施：

Interventions：

组别：

对照组

样本量：

54

Group：

Control group

Sample size：

干预措施：

氨溴特罗口服液，口服，每日2次，疗程7天。

干预措施代码：

Intervention：

Ambroterol Oral Liquid, taken orally, twice a day, for a course of 7 days.

Intervention code：

组别：

试验组

样本量：

54

Group：

Experimental group

Sample size：

干预措施：

清宣止咳颗粒，温开水冲服，每日3次，疗程7天。

干预措施代码：

Intervention：

Qingxuan Zhike Granules, taken with warm boiled water, three times a day, for a course of 7 days.

Intervention code：

样本总量 Total sample size ： 108

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

辽宁

市(区县)：

沈阳市

Country：

China

Province：

Liaoning

City：

Shenyang

单位(医院)：

辽宁中医药大学附属第二医院

单位级别：

三级甲等

Institution/hospital：

The Second Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

Level of the institution：

tertiary hospital

国家：

中国

省(直辖市)：

辽宁

市(区县)：

沈阳市

Country：

China

Province：

Liaoning

City：

Shenyang

单位(医院)：

辽宁中医药大学附属医院

单位级别：

三级甲等

Institution/hospital：

Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

Level of the institution：

tertiary hospital

国家：

中国

省(直辖市)：

辽宁

市(区县)：

沈阳市

Country：

China

Province：

Liaoning

City：

Shenyang

单位(医院)：

辽宁省妇幼保健院

单位级别：

三级甲等

Institution/hospital：

Liaoning Provincial Maternal and Child Health Hospital

Level of the institution：

tertiary hospital

测量指标：

Outcomes：

指标中文名：

血常规

指标类型：

次要指标

Outcome：

Blood routine

Type：

Secondary indicator

测量时间点：

入组时、第7天

测量方法：

手持采血针，以15 - 30度角快速、准确地刺入静脉，见回血后固定针头位置，将采血管插入采血针的采血端，采集足量血液（一般为2 - 3毫升）。

Measure time point of outcome：

When enrolling in the group、The seventh day

Measure method：

Hold the blood collection needle and quickly and accurately insert it into the vein at an Angle of 15 to 30 degrees. After the blood returns, fix the needle position and insert the blood collection tube into the blood collection end of the blood collection needle to collect a sufficient amount of blood (usually 2 to 3 milliliters).

指标中文名：

心肌酶谱

指标类型：

附加指标

Outcome：

myocardial enzyme spectrum

Type：

Additional indicator

测量时间点：

入组时、第7天

测量方法：

常规采血后，实验室化验检查。

Measure time point of outcome：

When enrolling in the group、The seventh day

Measure method：

After routine blood collection, laboratory tests are conducted

指标中文名：

肾功能

指标类型：

副作用指标

Outcome：

renal function

Type：

Adverse events

测量时间点：

入组时、第7天

测量方法：

常规采血后，实验室化验检查。

Measure time point of outcome：

When enrolling in the group、The seventh day

Measure method：

After routine blood collection, laboratory tests are conducted

指标中文名：

儿童睡眠习惯问卷（CSHQ）

指标类型：

附加指标

Outcome：

Children's Sleep Habits Questionnaire (CSHQ)

Type：

Additional indicator

测量时间点：

入组时、第7天

测量方法：

请患儿家长协助完成病例观察表中该项目的填写，并据此计算评分。

Measure time point of outcome：

When enrolling in the group、The seventh day

Measure method：

Please ask the parents of the child patients to assist in filling in this item in the case observation form and calculate the score accordingly.

指标中文名：

血清白介素-18（IL-18）

指标类型：

次要指标

Outcome：

Interleukin 18 (IL-18)

Type：

Secondary indicator

测量时间点：

入组时、第7天

测量方法：

通过ELISA (酶联免疫吸附测定)试剂盒进行测定。

Measure time point of outcome：

When enrolling in the group、The seventh day

Measure method：

The determination was carried out through an ELISA (Enzyme-linked Immunosorbent assay) kit.

指标中文名：

咳嗽视觉模拟评分（VAS）

指标类型：

次要指标

Outcome：

Cough Visual Analogue Scale (VAS)

Type：

Secondary indicator

测量时间点：

入组时、第7天

测量方法：

治疗后咳嗽VAS评分改善率计算公式：VAS评分改善率 = (治疗前VAS评分—治疗后VAS评分*）/ 治疗前VAS评分 × 100%

Measure time point of outcome：

When enrolling in the group、The seventh day

Measure method：

The calculation formula for the improvement rate of cough VAS score after treatment: VAS score improvement rate = (VAS score before treatment - VAS score after treatment *)/VAS score before treatment × 100%

指标中文名：

X线胸片

指标类型：

次要指标

Outcome：

X-ray chest film

Type：

Secondary indicator

测量时间点：

入组时、第7天

测量方法：

患儿双臂上举夹头，固定上、下肢，患儿冠状面与平板探测器平行，X线中心线，经小儿第6胸椎垂直射入平板探测器。

Measure time point of outcome：

When enrolling in the group、The seventh day

Measure method：

The child raised the clamps with both arms to fix the upper and lower limbs. The coronal plane of the child was parallel to the flat panel detector. The center line of the X-ray was vertically injected into the flat panel detector through the sixth thoracic vertebra of the child.

指标中文名：

止咳起效时间评价

指标类型：

次要指标

Outcome：

Evaluation of the onset time of cough relief

Type：

Secondary indicator

测量时间点：

每24 h记录1次，以天计算。

测量方法：

止咳起效时间评价，指首次服药后咳嗽评分下降2分所需要的天数。每24 h记录1次，以天计算。

Measure time point of outcome：

Record once every 24 hours, calculated on a daily basis.

Measure method：

The evaluation of the onset time of cough relief refers to the number of days required for the cough score to drop by 2 points after the first medication. Record once every 24 hours, calculated on a daily basis.

指标中文名：

血清白介素-4（IL-4）

指标类型：

次要指标

Outcome：

Interleukin 4

Type：

Secondary indicator

测量时间点：

入组时、第7天

测量方法：

通过ELISA (酶联免疫吸附测定)试剂盒进行测定。

Measure time point of outcome：

When enrolling in the group、The seventh day

Measure method：

The determination was carried out through an ELISA (Enzyme-linked Immunosorbent assay) kit.

指标中文名：

疾病疗效应答率

指标类型：

次要指标

Outcome：

Disease efficacy response rate

Type：

Secondary indicator

测量时间点：

疗程中第1、3、5、7天。

测量方法：

根据病例观察表中的评分项目，在疗程中分时间点对各项症状进行评分，并依据公式计算疗效应答率。

Measure time point of outcome：

The 1st 3rd 5th and 7th days of the treatment course.

Measure method：

According to the scoring items in the case observation table each symptom was scored at different time points during the treatment course and the therapeutic response rate was calculated based on the formula.

指标中文名：

肝功能

指标类型：

副作用指标

Outcome：

liver function

Type：

Adverse events

测量时间点：

入组时、第7天

测量方法：

常规采血后，实验室化验检查。

Measure time point of outcome：

When enrolling in the group、The seventh day

Measure method：

After routine blood collection, laboratory tests are conducted

指标中文名：

中医证候有效率

指标类型：

主要指标

Outcome：

The effective rate of TCM syndromes

Type：

Primary indicator

测量时间点：

入组时、第7天

测量方法：

根据病例观察表中的评分项目，分别计算患儿入组前和在疗程结束后各项症状评分，并依据公式计算中医证候有效率。

Measure time point of outcome：

When enrolling in the group、The seventh day

Measure method：

According to the scoring items in the case observation table, the symptom scores of each child before enrollment and after the end of the treatment course were calculated respectively, and the effective rate of TCM syndromes was calculated based on the formula.

指标中文名：

咳嗽程度评分（CET）

指标类型：

次要指标

Outcome：

Cough Severity Score (CET)

Type：

Secondary indicator

测量时间点：

入组时、第7天

测量方法：

请患儿家长协助完成病例观察表中该项目的填写，并据此计算评分。

Measure time point of outcome：

When enrolling in the group、The seventh day

Measure method：

Please ask the parents of the child patients to assist in filling in this item in the case observation form and calculate the score accordingly.

指标中文名：

尿常规

指标类型：

副作用指标

Outcome：

Urine routine

Type：

Adverse events

测量时间点：

入组时、第7天

测量方法：

患儿尿液经采集后进行实验室化验检查。

Measure time point of outcome：

When enrolling in the group、The seventh day

Measure method：

The urine of the child patient was collected and then tested in the laboratory.

指标中文名：

血清干扰素-γ（IFN-γ）

指标类型：

次要指标

Outcome：

Interferon-gamma

Type：

Secondary indicator

测量时间点：

入组时、第7天

测量方法：

通过ELISA (酶联免疫吸附测定)试剂盒进行测定。

Measure time point of outcome：

When enrolling in the group、The seventh day

Measure method：

The determination was carried out through an ELISA (Enzyme-linked Immunosorbent assay) kit.

指标中文名：

血清白细胞介素-17（IL-17）

指标类型：

次要指标

Outcome：

Interleukin 17

Type：

Secondary indicator

测量时间点：

入组时、第7天

测量方法：

通过ELISA (酶联免疫吸附测定)试剂盒进行测定。

Measure time point of outcome：

When enrolling in the group、The seventh day

Measure method：

The determination was carried out through an ELISA (Enzyme-linked Immunosorbent assay) kit.

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

尿液采集后首先进行实验室化验检查，随后由辽宁中医药大学附属第二医院检验科定期销毁处理。

Fate of sample 

Destruction after use

Note：

After urine collection it is first tested in the laboratory and then regularly destroyed and disposed of by the Laboratory Department of the Second Affiliated Hospital of Liaoning University of Traditional Chinese Medicine.

标本中文名：

血液

组织：

Sample Name：

Blood

Tissue：

人体标本去向

使用后保存

说明

血样经离心后首先进行实验室化验检查，随后送往辽宁中医药大学附属第二医院科研楼-80℃冰箱登记储存。

Fate of sample 

Preservation after use

Note：

After centrifugation, the blood samples were first subjected to laboratory tests and examinations, and then sent to the -80℃ refrigerator in the Research Building of the Second Affiliated Hospital of Liaoning University of Traditional Chinese Medicine for registration and storage.

征募研究对象情况：

尚未开始

Not yet recruiting

年龄范围：

最小 1 岁
Min age years
最大 14 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）：

随即方法采用分层区组随机化方法，由团队统计学老师严格遵循统计学原则，设计分层区组随机化的序列，使用计算机软件（R）生成随机序列，种子值（seed）设为固定数（12345）以确保可重复性。序列生成基于均匀分布随机数。

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

The random method adopted the stratified block randomization method. The team statistics teachers strictly followed the statistical principles to design the stratified block randomization sequence. The random sequence was generated using computer software (R) and the seed value (seed) was set as a fixed number (12345) to ensure repeatability. Sequence generation is based on uniformly distributed random numbers

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）：

将于国际传统医学临床试验注册平台公开本项试验原始数据，公开日期预计在2026年12月

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

The original data of this trial will be made public on the International Traditional Medicine Clinical Trial Registry Platform, and the public release date is expected to be December 2026

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.数据的采集：采集住院患者第一手临床试验数据资料应记录于《病例报告表》中。《病例报告表》为受试儿童医疗源文件，记录和审核要求包括：①研究者必须在诊治受儿童同时填写《病例报告表》，保证数据记录及时、完整、准确、真实。②《病例报告表》做任何有证据的更正时只能划线，旁注改后的数据，由研究者签名并注明日期，不得擦除、覆盖原始记录。③受试儿童的化验单复印件粘贴在《病例报告表》上。④每一位受试儿童治疗与随访结束后，研究者应将《病例报告表》（CRF）、《知情同意书》等交分中心项目负责人（主要研究者）审核、签名，然后交牵头单位，发现问题及时处理并记录。 2.数据的报告：《病例报告表》由临床研究者填写，完成的《病例报告表》由各中心监查员审查后，进行数据录入与管理工作。 3.数据库的监查：监查员的人数与访视频度必须满足临床试验的质控要求。监查员审核每份《病例报告表》，并逐份填写“监查员审核页”。 4.数据的录入、核查和锁定：①在第一份CRF送到以前，由数据管理员采用电子数据采集系统（EDC）建立数据库。数据管理员还应对每一份CRF进行初步审核，再交由两名操作人员独立地输入数据库中，并用软件对两份输入结果进行比较。如果有不一致，对照CRF查找原因，加以更正。数据管理员按CRF中各指标数值的范围、撰写数据核查计划和核查程序。所有错误内容及修改结果应有详细记录并妥善保存。如有必要，可再次对数据库中的指标（特别是主要指标）进行全部或抽样的人工检查，并与CRF进行核对。②上述工作完成后，由主要研究者、申办单位、试验统计学专业人员和数据管理员进行盲态审核。盲态审核中确定每个病例所属分析集、缺失值的处理及离群值的判断等。经盲态审核认为所建立的数据库正确无误后，对数据库进行锁定。③数据锁定后抽取10%的CRF进行错误率检查。主要疗效指标错误率要求0%，其它指标错误率要求在0.3%以下。如果错误率超过该要求，将通知申办单位重新打开数据库，进行修改及寻找错误原因。 5.数据可溯源性的规定：应保存质量控制性文件，如数据一致性检查，数值范围和逻辑检查的原始记录，盲态核查时的原始记录、研究者与监查员之间交流的疑问记录等。保存所有原始档案，并备份电子数据。

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

Data collection: The first-hand clinical trial data of inpatients collected should be recorded in the "Case Report Form". The "Case Report Form" serves as the medical source document for the subject children. The requirements for recording and reviewing include: ① Researchers must fill out the "Case Report Form" simultaneously when diagnosing and treating the subject children to ensure that the data is recorded in a timely complete accurate and true manner. When any correction with evidence is made to the "Case Report Form" it can only be underlined with the corrected data noted beside it. The correction must be signed by the researcher and dated. The original records must not be erased or overwritten. A copy of the test report of the child under test should be pasted on the "Case Report Form". After the treatment and follow-up of each subject child are completed the researcher should submit the "Case Report Form" (CRF) "Informed Consent Form" etc. to the project leader (principal investigator) of the sub-center for review and signature and then hand them over to the leading unit. Any problems found should be dealt with promptly and recorded. 2. Data Reporting: The "Case Report Form" is filled out by clinical researchers. After the completed "Case Report Form" is reviewed by the monitors of each center data entry and management work is carried out. 3. Database monitoring: The number of monitors and the degree of video visits must meet the quality control requirements of clinical trials. The monitor reviews each "Case Report Form" and fills in the "Monitor Review Page" one by one. 4. Data entry verification and locking: ① Before the first CRF is delivered the data administrator shall establish a database using the Electronic Data Acquisition System (EDC). The data administrator should also conduct a preliminary review of each CRF and then hand it over to two operators to independently input it into the database and compare the two input results with software. If there are any inconsistencies refer to the CRF to find out the causes and make corrections. The data administrator writes the data verification plan and verification procedures according to the range of each indicator value in the CRF. All error contents and modification results should be recorded in detail and properly preserved. If necessary a full or sampled manual check of the indicators in the database (especially the main indicators) can be conducted again and compared with the CRF. After the completion of the above work a blind review will be conducted by the principal investigator the sponsor institution the trial statistics professional and the data administrator. In blind review determine the analysis set to which each case belongs handle the missing values and judge the outliers etc. After the blind review deems the established database correct and error-free the database is locked. After data locking 10% of the CRF is extracted for error rate checking. The error rate of the main efficacy indicator is required to be 0% and the error rate of other indicators is required to be below 0.3%. If the error rate exceeds this requirement the applying unit will be notified to reopen the database make modifications and find the cause of the error. 5. Regulations on data traceability: Quality control documents should be kept such as original records of data consistency checks numerical range and logical checks original records during blind verification and records of questions exchanged between researchers and monitors etc. Save all original archives and back up electronic data.

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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