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评价感冒双解颗粒治疗流行性感冒（表寒里热证）的有效性和安全性的多中心、随机、双盲、剂量平行、安慰剂对照Ⅱ期临床试验

注册号：

Registration number：

ITMCTR2100005067

最近更新日期：

Date of Last Refreshed on：

2021-03-10

注册时间：

Date of Registration：

2021-03-10

注册号状态：

Registration Status：

补注册

Retrospective registration

注册题目：

评价感冒双解颗粒治疗流行性感冒（表寒里热证）的有效性和安全性的多中心、随机、双盲、剂量平行、安慰剂对照Ⅱ期临床试验

Public title：

A multi-center, randomized, double-blind, dose-parallel, placebo-controlled phase II clinical trial to evaluate the effectiveness and safety of Ganmao Shuangjie Granules in the treatment of influenza (external cold, internal heat syndrome)

注册题目简写：

English Acronym：

研究课题的正式科学名称：

验评价感冒双解颗粒治疗流行性感冒（表寒里热证）的有效性和安全性的多中心、随机、双盲、剂量平行、安慰剂对照Ⅱ期临床试

Scientific title：

A multi-center, randomized, double-blind, dose-parallel, placebo-controlled phase II clinical trial to evaluate the effectiveness and safety of Ganmao Shuangjie Granules in the treatment of influenza (external cold, internal heat syndrome)

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：

ChiCTR2100044093 ; ChiMCTR2100005067

申请注册联系人：

刘国瑞

研究负责人：

董志奎

Applicant：

Guorui Liu

Study leader：

Zhikui Yao

申请注册联系人电话：

Applicant telephone：

+86 13466643019

研究负责人电话：

Study leader's telephone：

+86 010-80728999-6777

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：

liuguorui@yangzijiang.com

研究负责人电子邮件：

Study leader's E-mail：

dongzhikui@yangzijiang.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：

江苏省泰州市扬子江南路1号

研究负责人通讯地址：

江苏省泰州市扬子江南路1号

Applicant address：

1 Yangzijiang Road South, Gaogang District, Taizhou, Jiangsu, China

Study leader's address：

1 Yangzijiang Road South, Gaogang District, Taizhou, Jiangsu, China

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：

扬子江药业集团有限公司

Applicant's institution：

Yangtze River Pharmaceutical (Group) Co., Ltd.

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：

2019BL01-010-02

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：

首都医科大学附属北京中医医院医学伦理委员会

Name of the ethic committee：

Beijing Hospital of Traditional Chinese Medicine Medical Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

2019/11/15 0:00:00

伦理委员会联系人：

王晶

Contact Name of the ethic committee：

Jing Wang

伦理委员会联系地址：

北京市东城区美术馆后街23号

Contact Address of the ethic committee：

23 Art Gallery Back Street, Dongcheng District, Beijing, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 10-52176734

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：

首都医科大学附属北京中医医院

Primary sponsor：

Beijing Hospital of Traditional Chinese Medicine

研究实施负责（组长）单位地址：

北京市东城区美术馆后街23号

Primary sponsor's address：

23 Art Gallery Back Street, Dongcheng District, Beijing, 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)：

北京

市(区县)：

东城区

Country：

China

Province：

Beijing

City：

Dongcheng District

单位(医院)：

首都医科大学附属北京中医医院

具体地址：

美术馆后街23号

Institution
hospital：

Beijing Hospital of Traditional Chinese Medicine

Address：

23 Art Gallery Back Street, Dongcheng District

经费或物资来源：

扬子江药业集团有限公司

Source(s) of funding：

Yangtze River Pharmaceutical (Group) Co., Ltd.

研究疾病：

流行性感冒（表寒里热证）

研究疾病代码：

Target disease：

influenza (external cold, internal heat syndrome

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：

II期临床试验

Phase II clinical trial

研究目的：

初步评价感冒双解颗粒治疗流行性感冒的有效性和安全性；探索感冒双解颗粒治疗流行性感冒的作用特点和优势剂量；为下一步临床研究设计提供支持。

Objectives of Study：

To preliminarily evaluate the effectiveness and safety of Ganmao Shuangjie Granules in the treatment of influenza; explore the characteristics and advantageous doses of Ganmao Shuangjie Granules in the treatment of influenza; provide support for the next clinical research design.

药物成份或治疗方案详述：

处方组成：葛根（野葛）、柴胡（北柴胡）、黄芩、射干、石膏、麻黄、紫苏叶、羌活、辛夷、甘草。药用辅料为三氯蔗糖、β环糊精、糊精。受试者首先进行筛选检查，符合条件的受试者进行5天的试验药物或安慰剂治疗，在用药结束当天或用药结束后1天完成相关检查，整个研究需要约6至7天

Description for medicine or protocol of treatment in detail：

Prescription composition: Pueraria lobata (Pueraria lobata), Bupleurum (Buihu), Scutellaria baicalensis Georgi, Shegan, Gypsum, Ephedra, Perilla leaf, Qianghuo, Xinyi, Licorice. The pharmaceutical excipients are sucralose, β-cyclodextrin and dextrin.Subjects will be screened and inspected first. Eligible subjects will be treated with the test drug or placebo for 5 days, and the relevant inspection will be completed on the day of the end of the medication or 1 day after the end of the medication. The entire study takes about 6 to 7 days.

纳入标准：

以下标准筛选时必须全部符合方可纳入试验 （1）符合流行性感冒临床诊断； （2）流感快速抗原检测结果为阳性； （3）就诊时，38℃≤体温（腋下）＜39.5℃； （4）流感症状初起至就诊，在本次病程48小时内； （5）中医辨证为表寒里热证； （6）年龄18～65周岁（含18和65周岁），性别不限； （7）自愿参加本项临床试验并签署书面知情同意书。

Inclusion criteria

All of the following criteria must be met during screening before being included in the trial (1) Meet the clinical diagnosis of influenza; (2) The result of influenza rapid antigen test is positive; (3) At the time of treatment, body temperature (underarm) 38 to 39.5 degrees C; (4) Influenza symptoms from the first to the clinic, within 48 hours of the current course; (5) TCM syndrome differentiation is the outer cold and inner heat syndrome; (6) Aged from 18 to 65 years old; (7) Volunteer to participate in this clinical trial and sign a written informed consent.

排除标准：

以下标准筛选时必须全部不符合方可纳入试验 （1）临床诊断为重症或危重流感； （2）血常规检查白细胞总数＞10.0×10^9/L，或中性粒细胞百分比＞80%，或具有脓痰症状，怀疑细菌感染； （3）其他类型的呼吸道感染包括急性鼻炎、鼻窦炎、气管-支气管炎和肺炎； （4）伴有慢性呼吸系统疾病（如慢阻肺等）、心血管系统疾病（如冠心病、心肌炎等，不包括血压控制稳定的高血压、无症状的陈旧性腔隙脑梗塞）、肾病、肝病、血液系统疾病、神经系统及神经肌肉疾病、代谢及内分泌系统疾病（如糖尿病）、免疫功能抑制(包括应用免疫抑制剂或HIV感染等致免疫功能低下)； （5）BMI大于30[BMI=体重(kg)/身高(m)2]； （6）本次病程内，随机化前已接受抗病毒药物治疗； （7）近一年内接种过流感疫苗； （8）过敏性疾病（如过敏性鼻炎、过敏性哮喘等），或对试验药物过敏，包括对本品成分、对乙酰氨基酚或者药物辅料有过敏史； （9）妊娠或未来3个月内计划妊娠的女性，哺乳期妇女；试验期间或末次用药后1个月内，不能或不愿意采取充分避孕的育龄期女性或其配偶不愿意采取避孕措施； （10）因患有其他疾病不能或不愿配合临床试验； （11）怀疑或确有酒精或药物滥用史； （12）近3个月内参加过其他临床试验或正在参加其他药物临床试验； （13）医生认为不适宜参加临床试验。

Exclusion criteria：

All of the following criteria must not be met during screening before they can be included in the trial (1) Clinically diagnosed as severe or critical influenza; (2) The total number of white blood cells in routine blood examination > 10.0 x 10^9/L, or the percentage of neutrophils > 80%, or symptoms of purulent sputum, suspected of bacterial infection; (3) Other types of respiratory infections include acute rhinitis, sinusitis, tracheal-bronchitis and pneumonia; (4) Accompanied by chronic respiratory diseases (such as chronic obstructive pulmonary disease, etc.), cardiovascular diseases (such as coronary heart disease, myocarditis, etc., excluding high blood pressure with stable blood pressure control, asymptomatic old lacunar infarction), nephropathy , Liver disease, blood system disease, nervous system and neuromuscular disease, metabolic and endocrine system disease (such as diabetes), immune function suppression (including the application of immunosuppressive agents or HIV infection caused by immune; (5) BMI is greater than 30[BMI=weight (kg)/height (m)2]; (6) During the course of this disease, they have received antiviral treatment before randomization; (7) Have received influenza vaccine in the past year; (8) Allergic diseases (such as allergic rhinitis, allergic asthma, etc.), or allergies to test drugs, including allergies to the ingredients of this product, acetaminophen or pharmaceutical excipients; (9) Women who are pregnant or plan to become pregnant within the next 3 months, or breast-feeding women; women of childbearing age who are unable or unwilling to take adequate contraception during the trial period or within one month after the last medication, or their spouses are not willing to take contraceptive measures; (10) Unable or unwilling to cooperate with clinical trials due to other diseases; (11) Suspected or true history of alcohol or drug abuse; (12) Participated in other clinical trials or are participating in clinical trials of other drugs in the past 3 months; (13) Doctors think it is not suitable to participate in clinical trials.

研究实施时间：

Study execute time：

从From 2020-12-13

至To      2020-05-28

征募观察对象时间：

Recruiting time：

从From 2019-12-20

至To      2020-01-21

干预措施：

Interventions：

组别：

大剂量组

样本量：

80

Group：

High dose group

Sample size：

干预措施：

感冒双解颗粒，一次2袋，一日3次，早、中、晚开水冲服

干预措施代码：

Intervention：

Ganmao Shuangjie Granules, 2 bags at a time, 3 times a day, take with boiling water in the morning, middle and evening

Intervention code：

组别：

安慰剂组

样本量：

80

Group：

Placebo group

Sample size：

干预措施：

感冒双解颗粒模拟剂，一次2袋，一日3次，早、中、晚开水冲服。

干预措施代码：

Intervention：

Ganmao Shuangjie Granule Simulator, 2 sachets at a time, 3 times a day, take it with boiling water in the morning, middle and evening.

Intervention code：

组别：

小剂量组

样本量：

80

Group：

Small dose group

Sample size：

干预措施：

感冒双解颗粒1袋+感冒双解颗粒模拟剂1袋，一日3次，早、中、晚开水冲服。

干预措施代码：

Intervention：

1 bag of Ganmao Shuangjie Granules + 1 bag of Ganmao Shuangjie Granules Simulator, 3 times a day, take it with boiling water in the morning, middle and evening.

Intervention code：

样本总量 Total sample size ： 240

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

北京

市(区县)：

东城区

Country：

China

Province：

Beijing

City：

Dongcheng District

单位(医院)：

首都医科大学附属北京中医医院

单位级别：

三甲

Institution/hospital：

Beijing Hospital of Traditional Chinese Medicine

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

中医证候疗效

指标类型：

主要指标

Outcome：

Curative effect of TCM syndromes

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

流感症状评分

指标类型：

主要指标

Outcome：

flu symptom score

Type：

Primary indicator

测量时间点：

测量方法：

体温计

Measure time point of outcome：

Measure method：

thermometer

指标中文名：

服用对乙酰氨基酚片情况比较

指标类型：

主要指标

Outcome：

Comparison of taking acetaminophen tablets

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

并发症/重症/危重症发生率

指标类型：

主要指标

Outcome：

Complications/severe/critically ill incidence

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

体温（腋下）

指标类型：

主要指标

Outcome：

Body temperature (underarm)temperature

Type：

Primary indicator

测量时间点：

测量方法：

体温计

Measure time point of outcome：

Measure method：

thermometer

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

鼻咽分泌物

组织：

鼻、咽

Sample Name：

Nasopharyngeal discharge

Tissue：

Nose, pharynx

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 18 岁
Min age years
最大 65 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）：

区组随机化方法，选取合适的区组长度，根据给定随机种子数，借助SAS统计软件，按照1：1：1比例产生420例受试者所接受治疗组（大剂量、小剂量、安慰剂）的随机序列，列出分配药物编号（001～420），即随机编码表。研究者按受试者入组次序依次分配药物编号。

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

Block randomization method，select the appropriate block length, according to the given number of random seeds, with the help of SAS statistical software, generate a random sequence of the treatment group (high dose, low dose, placebo) received by 420 subjects in a ratio of 1:1:1.

盲法：

（1）安慰剂研制 根据《中药新药临床研究一般原则》要求制备安慰剂，使安慰剂在颜色、气味、味道、形状、质感等特征方面与受试药物相似，使临床试验参与者难以区分。 （2）药物包装 安慰剂与受试药物在规格、外观、包装、标签、标识等方面一致，并标明为临床试验专用。 （3）包装和编号 由与本次试验的临床观察、监查、统计分析等无关的人员，根据已形成的随机序列对试验药物和安慰剂进行编码，将相应的药物编号贴在药物外部包装的醒目位置。 （4）应急信件的准备 1）密闭不透光信封上印有感冒双解颗粒Ⅱ期临床试验的应急信件、药物编号和遇紧急情况揭盲的规定。 2）信封内印有该受试者的服药信息、处理方法。应急信件随试验药物发往各中心，在试验结束后统一收回。 （5）编盲记录 药物编码过程由编盲者书写成文件形式，即编盲记录，作为该临床试验的文件之一保存。其内容包括：药物的包装，用法，储存要求，药物发放办法，随机序列的产生，按每个受试者包装的药盒，应急信件，盲底的保存，揭盲的规定等。 （6）盲底的保存 随机序列，连同产生随机数的随机种子数、区组长度等参数形成的随机表文件，密封后一式三份分别由主要研究者、申办方和统计单位保存，任何人不得私自保存盲底信件和应急信件，如随意拆阅盲底信件，可视为此次临床试验的失败，如无故拆阅应急信件，以脱落病例处理。

Blinding：

(1) Placebo development According to the requirements of "General Principles for Clinical Research of New Chinese Medicines", placebos are prepared so that the placebo is similar to the test drug in terms of color, smell, taste, shape, texture and other characteristics, making it difficult for clinical trial participants to distinguish. (2) Drug packaging The placebo is consistent with the test drug in terms of specifications, appearance, packaging, labeling, and identification, and is marked as a clinical trial. (3) Packaging and numbering Personnel who have nothing to do with the clinical observation, monitoring, statistical analysis, etc. of this trial will code the trial drug and placebo according to the formed random sequence, and stick the corresponding drug number on the eye-catching position of the outer package of the drug. (4) Preparation of emergency letters 1) The airtight opaque envelope is printed with the emergency letter of the phase II clinical trial of Ganmao Shuangjie Granules, the drug number and the regulations on unblinding in emergency. 2) The subject's medication information and treatment methods are printed in the envelope. The emergency letter was sent to each center along with the test drug, and was retrieved after the test. (5) Blind record The drug coding process is written by the blind editor into a file, that is, the blind record, which is kept as one of the clinical trial files. The contents include: drug packaging, usage, storage requirements, drug distribution methods, generation of random sequences, medicine boxes packaged for each subject, emergency letters, blind storage, unblinding regulations, etc. (6) Preservation of the blind bottom The random sequence, together with the random table file formed by the random seed number, block length and other parameters that generate the random number, are sealed and kept in triplicate by the main researcher, sponsor, and statistical unit. No one is allowed to keep blind letters and Emergency letters, such as the blind letters at random, can be regarded as the failure of the clinical trial. If the emergency letters are read without reason, they will be handled as dropped cases.

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个月公开在百度云网盘http://pan.baidu.com/share/manage

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

Experimental openly in the six months after the completion of baidu cloud network location at http://pan.baidu.com/share/manage

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、临床试验筛选时，应保留相关筛选记录，包括受试者的人口学资料、一般体格检查、病史、病程及治疗、伴随疾病及伴随治疗、实验室检查化验单、重要的疾病诊断依据等，核实受试者筛选的入选/排除标准，并记录在eCRF中在临床试验实施过程中，受试者接受的所有治疗均应如实详细记录在eCRF中，并客观评估其对有效性和安全性的影响。 eCRF填写 对于每一位进入本研究的受试者，数据录入由临床研究者或由研究者授权的研究助理完成。 eCRF中的数据应与原始记录一致，试验中的任何观察、检查结果均应及时、准确、完整、规范、真实地填写于eCRF中，不得随意更改。eCRF中所有项目均需填写，不得空项或遗漏。如有需要，eCRF进行数据更正时，需按照系统提示，填写数据修改的原因。 eCRF审核 研究者在每位受试者当前访视结束后，在规定时间内完成eCRF的填写，审核并提交。研究者应及时回复来自监查员、数据管理员、医学审核人员的质疑。在数据清理完成后，研究者对填写完毕的eCRF签名确认。 数据核查 研究者填写并提交eCRF后，监查员、数据管理员以及医学审核人员应对数据进行审核，审核发现的问题，以质疑的形式要求研究者回答。数据清理完毕后，eCRF需研究者电子签名确认 2、本研究采用电子数据采集（EDC）系统，通过EDC系统的电子数据录入、数据的验证、数据的核查等功能，完成在线数据管理。EDC系统管理员根据研究者、监查员、稽查员、数据管理员等不同角色，分别创建不同账号，依据用户使用人的不同角色设定相应的权限。

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

1. During clinical trial screening, relevant screening records should be kept, including demographic data, general physical examination, medical history, course and treatment of the subject, concomitant diseases and concomitant treatment, laboratory test reports, important disease diagnosis basis, etc. , To verify the selection/exclusion criteria of the subject screening and record it in the eCRF. During the implementation of the clinical trial, all the treatments received by the subject should be truthfully recorded in the eCRF and objectively evaluated for effectiveness and safety Impact. eCRF fill For each subject who enters this study, data entry is completed by the clinical investigator or a research assistant authorized by the investigator. The data in the eCRF should be consistent with the original record, and any observations and inspection results in the test should be filled in the eCRF in a timely, accurate, complete, standardized and true manner, and should not be changed at will. All items in the eCRF must be filled in, and no blanks or omissions are allowed. If necessary, when eCRF performs data correction, you need to follow the system prompts and fill in the reason for the data modification. eCRF review After the current visit of each subject is over, the researcher will complete the eCRF fill-in, review and submit within the specified time. Researchers should promptly respond to queries from monitors, data administrators, and medical reviewers. After the data cleaning is completed, the researcher confirms the completed eCRF signature. Data check After the researcher fills in and submits the eCRF, the monitors, data administrators, and medical reviewers should review the data, and ask the researcher to answer the questions found in the review in the form of queries. After the data is cleaned, eCRF requires the researcher’s electronic signature to confirm 2. This research uses an electronic data collection (EDC) system to complete online data management through the electronic data entry, data verification, and data verification functions of the EDC system. The EDC system administrator creates different accounts according to the different roles of researchers, inspectors, auditors, data administrators, etc., and sets corresponding permissions according to the different roles of users.

数据管理委员会：

Data Managemen Committee：

无

No

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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