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A randomized, double-blind, controlled clinical study on the intervention of Shudi Suoyang Decoction granule in PF-ILD with kidney essence deficiency syndrome

注册号：

Registration number：

ITMCTR2100004924

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：

预注册

Prospective registration

注册题目：

熟地锁阳汤颗粒剂干预PF-ILD肾精亏虚证的随机、双盲、对照临床研究方案

Public title：

A randomized, double-blind, controlled clinical study on the intervention of Shudi Suoyang Decoction granule in PF-ILD with kidney essence deficiency syndrome

注册题目简写：

English Acronym：

研究课题的正式科学名称：

熟地锁阳汤颗粒剂干预PF-ILD肾精亏虚证的随机、双盲、对照临床研究方案

Scientific title：

A randomized, double-blind, controlled clinical study on the intervention of Shudi Suoyang Decoction granule in PF-ILD with kidney essence deficiency 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：

ChiCTR2100047131 ; ChiMCTR2100004924

申请注册联系人：

刘建

研究负责人：

王玉光

Applicant：

Liu Jian

Study leader：

Wang Yuguang

申请注册联系人电话：

Applicant telephone：

+86 13466367749

研究负责人电话：

Study leader's telephone：

+86 18600375558

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：

liujian5065@163.com

研究负责人电子邮件：

Study leader's E-mail：

wygzhyiaids@126.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：

北京市东城区美术馆后街23号

研究负责人通讯地址：

北京市东城区美术馆后街23号

Applicant address：

23 Art Gallery Back Street, Dongcheng District, Beijing

Study leader's address：

23 Art Gallery Back Street, Dongcheng District, Beijing

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：

首都医科大学附属北京中医医院

Applicant's institution：

Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University

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：

2021BL02-029-02

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：

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：

Medical Ethics Committee of Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

2021/3/24 0:00:00

伦理委员会联系人：

刘声

Contact Name of the ethic committee：

Liu Sheng

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

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 10 87906734

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 Affiliated to Capital Medical University

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

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 Affiliated to Capital Medical University

Address：

23 Art Gallery Back Street

经费或物资来源：

首都卫生发展科研专项项目

Source(s) of funding：

Capital Health Development Scientific Research Project

研究疾病：

间质性肺疾病

研究疾病代码：

Target disease：

Interstitial lung disease

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：

探究熟地锁阳汤对PF-ILD咳喘的治疗效果和安全性。

Objectives of Study：

Objective to explore the therapeutic effect and safety of Shudi Suoyang Decoction on cough and asthma of PF-ILD.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

1.年龄18-80岁； 2.PF-ILD西医诊断标准 参照内科学（第8版）、实用间质性肺疾病（第2版，人民卫生出版社），2013年ATS/ERS修订的IIP国际多学科新分类标准的非IPF的间质性肺疾病，以及PF-ILD文献综述汇总，临床诊断特征如下： (1)表现为慢性咳嗽、进行性加重的呼吸困难，活动耐力下降； (2)肺部听诊闻及爆裂音，伴或不伴杵状指，合并结缔组织疾病时可有原发病相应表现，如皮疹、关节疼痛、关节肿胀、雷诺现象等； (3)满足以下其中一种ILD的诊断： 特发性肺纤维化（IPF）、过敏性肺炎（HP）、自身免疫疾病相关性ILDs（包括类风湿性关节炎相关间质性肺疾病、系统性硬化症相关间质性肺疾病及混合性结缔组织疾病相关间质性肺疾病）、特发性非特异性间质性肺炎（iNSIP）、未能分类的特发性间质性肺炎（未能分类IIP）和其他ILDs（包括结节病、环境相关ILDs、其他原因导致的纤维性ILDs）； (4)胸部HRCT示双肺弥漫性异常改变，主要表现为蜂窝影、网格影、牵拉性支气管扩张影，伴或不伴磨玻璃影，其面积应小于网格面积； (5)除外肺内感染、肿瘤疾病等所致的肺内纤维化样改变； (6)治疗状态下24个月内满足其一： 1)用力肺活量（FVC）相对下降>=10%； 2)FVC相对下降>=5%并且一氧化碳弥散量（DLCO）预计值百分比绝对下降>=15%； 3)FVC相对下降>=5%，HRCT显示纤维化增加(根据影像学专家评估) ； 4)FVC相对下降>=5%伴呼吸系统症状加重； 5)呼吸系统症状加重伴HRCT显示有进行性表现(根据影像学专家评估)。 (7)目前无严格、统一疾病诊断，本研究只按照国际通用诊断标准进行西医疾病诊断。 3.肺功能检查：FVC（用力肺活量）预测值>=45%，且DLCO SB（一氧化碳弥散量）>=30%且<80%； 4.PF-ILD中医证候诊断标准 参照《中华人民共和国中医药行业标准-中医证候诊断标准》，结合课题组近7年对该类疾病的病例观察和临床诊治经验，发现PF-ILD的中医症候多见肾精亏虚证型，具体诊断特征如下：咳嗽少痰，痰色质白，活动后、遇异味加重；喘息气短，吸气尤难，呼吸浅短，动则加重，神疲倦怠，或乏力，腰膝酸软，畏寒肢冷，小便频数，或夜尿多，或咳时遗尿，舌质淡暗苔白，脉沉细缓无力，尺部尤甚。证候诊断标准如下： 证型：肾精亏虚证 主症：(1)咳嗽少痰，动则加重，或遇异味或其他刺激诱发；(2)喘息气短，吸气尤难，呼吸浅短，动则加重；(3)神疲倦怠，或乏力。 次证：(1)腰膝酸软；(2)畏寒肢冷；(3)小便频数，或夜尿多，或咳时遗尿；(4)易感冒。 舌脉：舌淡、暗、苔白。 脉象：沉、细、缓、无力，尺部尤甚。 符合主症中的2项，次证中1项者，符合舌脉特征，即可辨证为肾精亏虚证。

Inclusion criteria

1.Aged 18 to 80 years; 2.PF-ILD diagnostic criteria of wetern medicine Referring to internal medicine (8th Edition), practical interstitial lung disease (2nd Edition, people's Health Publishing House), IIP new international multidisciplinary classification of non IPF interstitial lung disease revised by ATS / ERS in 2013, and PF-ILD literature review, the clinical diagnostic characteristics are as follows: (1)The symptoms were chronic cough, progressive dyspnea and decreased activity tolerance. (2)Pulmonary auscultation and crackling sound with or without clubbed fingers, combined with connective tissue diseases can have the corresponding manifestations of primary disease, such as rash, joint pain, joint swelling, Raynaud's phenomenon and so on; (3)The diagnosis of ILD can meet one of the following requirements: idiopathic pulmonary fibrosis (IPF), hypersensitive pneumonia (HP), autoimmune disease-related ILDs (including rheumatoid arthritis related interstitial lung disease, systemic sclerosis related interstitial lung disease and mixed connective tissue disease-related interstitial lung disease), idiopathic non-specific interstitial pneumonia (ISIP) Unclassified idiopathic interstitial pneumonia (unclassified IIP) and other ILDs (including sarcoidosis, environment related ILDs, fibrous ILDs caused by other causes); (4)Chest HRCT showed diffuse abnormal changes in both lungs, mainly manifested as honeycomb shadow, grid shadow, tractive bronchodilation shadow, with or without ground glass shadow, whose area should be less than the grid area. (5)Pulmonary fibrosis like changes caused by pulmonary infection and tumor diseases were excluded. (6)Under the condition of treatment, one of the following conditions can be met within 24 months: 1)Relative decrease of forced vital capacity (FVC) >= 10%; 2)The relative decrease of FVC was more than 5%, and the absolute decrease of the predicted percentage of carbon monoxide dispersion capacity (DLCO) was more than 15%; 3)The relative decrease of FVC was more than 5%, and HRCT showed increased fibrosis (according to the evaluation of imaging experts); 4)FVC relative decrease >= 5% with aggravation of respiratory symptoms; 5)Aggravation of respiratory symptoms with progressive performance on HRCT (according to the evaluation of imaging experts). (7)At present, there is no strict and unified disease diagnosis, this study only according to the international general diagnostic standards for western medicine disease diagnosis. 3.Pulmonary function test: FVC (forced vital capacity) predicted value >= 45%, and DLCO sb (carbon monoxide dispersion volume) >= 30% and < 80%; 4.PF-ILD diagnostic criteria of TCM Syndromes Referring to the "Chinese medicine industry standard of the people's Republic of China - diagnosis standard of TCM syndrome", combined with the case observation and clinical diagnosis and treatment experience of the research group in recent 7 years, it is found that the TCM syndrome of PF-ILD is mainly kidney essence deficiency syndrome, and the specific diagnostic characteristics are as follows: cough less phlegm, white sputum color, aggravation of peculiar smell after activity; Short breath, especially difficult to inhale, shallow breathing, aggravation of movement, mental fatigue, or fatigue, waist and knee soreness, chilly limbs, frequent urination, or nocturia, or cough enuresis, tongue light dark, mossy white, pulse thin slow weakness, especially in the ulna. The diagnostic criteria were as follows: Syndrome type: kidney essence deficiency syndrome Main symptoms: (1)Cough with less phlegm, aggravation of movement, or induced by peculiar smell or other stimulation; (2)Wheezing is short, breathing is particularly difficult, breathing is shallow and short, moving is aggravated; (3)Mental fatigue or fatigue. Second syndrome: (1)Waist and knee soreness; (2) Chilly limbs; (3)Frequent urination, or nocturia, or cough enuresis; (4)Easy to catch cold. Tongue pulse: light, dark and white. Pulse: deep, thin, slow, weak, especially in the ulna. Conforming to 2 of the main symptoms and 1 of the secondary syndromes, conforming to the characteristics of tongue and pulse, can be differentiated as kidney essence deficiency syndrome.

排除标准：

1.妊娠期或哺乳期妇女，或在接受治疗过程中准备妊娠者； 2.对治疗药物或治疗药物中组成成分过敏者； 3.合并慢性阻塞性肺疾病、哮喘、肺栓塞等； 4.合并严重心功能不全、肝肾功能异常、造血系统障碍、各器官肿瘤等严重原发性疾病，以及有精神病病史和沟通困难的患者； 5.存在活动性感染的临床证据，例如急性支气管炎、肺炎、尿路感染、急性胃肠炎或蜂窝织炎等； 6.无法配合肺功能检查患者； 7.正在或者1月内参加过其他药物临床试验者； 8.间质性肺疾病急性加重（AE）期间。

Exclusion criteria：

1.Pregnant or lactating women, or preparing for pregnancy during treatment; 2.Allergic to therapeutic drugs or components of therapeutic drugs; 3.They were complicated with chronic obstructive pulmonary disease, asthma, pulmonary embolism, etc.; 4.Patients with severe primary diseases, such as severe cardiac insufficiency, liver and kidney dysfunction, hematopoietic system disorders, tumors of various organs, as well as psychiatric history and communication difficulties; 5.There is clinical evidence of active infection, such as acute bronchitis, pneumonia, urinary tract infection, acute gastroenteritis or cellulitis; 6.Unable to cooperate with lung function test; 7.Patients have participated in other drug clinical trials or within one month; 8.During acute exacerbation of interstitial lung disease (AE).

研究实施时间：

Study execute time：

从From 2020-07-01

至To      2023-06-30

征募观察对象时间：

Recruiting time：

从From 2021-08-01

至To      2022-04-01

干预措施：

Interventions：

组别：

试验组

样本量：

100

Group：

Experimental group

Sample size：

干预措施：

熟地锁阳汤颗粒剂

干预措施代码：

Intervention：

Shudi Suoyang Decoction granules

Intervention code：

组别：

对照组

样本量：

100

Group：

Control Group

Sample size：

干预措施：

熟地锁阳汤颗粒模拟剂

干预措施代码：

Intervention：

Shudi Suoyang Decoction granule simulant

Intervention code：

样本总量 Total sample size ： 200

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：

三级甲等

Institution/hospital：

Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

生活质量及健康状况评估

指标类型：

次要指标

Outcome：

Quality of life and health assessment

Type：

Secondary indicator

测量时间点：

基线、治疗后的第4周、8周、12周各评价一次

测量方法：

简明健康量表SF-36

Measure time point of outcome：

Evaluation was performed at baseline, 4, 8, and 12 weeks after treatment

Measure method：

Concise Health Inventory SF-36

指标中文名：

评估咳嗽敏感性

指标类型：

次要指标

Outcome：

Assess cough sensitivity

Type：

Secondary indicator

测量时间点：

基线、治疗后的第4周、12周各评价一次

测量方法：

Measure time point of outcome：

Evaluation was performed at baseline, 4 weeks after treatment, and 12 weeks after treatment

Measure method：

指标中文名：

用力肺活量的变化

指标类型：

次要指标

Outcome：

Changes in forced lung capacity

Type：

Secondary indicator

测量时间点：

基线、治疗后的第4周、12周各评价一次

测量方法：

Measure time point of outcome：

Evaluation was performed at baseline, 4 weeks after treatment, and 12 weeks after treatment

Measure method：

指标中文名：

一氧化碳弥散量（DLCO SB）预计值百分比与基线的绝对变化

指标类型：

次要指标

Outcome：

Absolute change in predicted percentage of carbon monoxide dispersion (DLCO SB) from baseline

Type：

Secondary indicator

测量时间点：

基线、治疗后的第4周、12周各评价一次

测量方法：

Measure time point of outcome：

Evaluation was performed at baseline, 4 weeks after treatment, and 12 weeks after treatment

Measure method：

指标中文名：

PF-ILD相关死亡

指标类型：

次要指标

Outcome：

PF-ILD-related deaths

Type：

Secondary indicator

测量时间点：

12周内

测量方法：

Measure time point of outcome：

12 weeks

Measure method：

指标中文名：

评估呼吸困难及对生活质量影响评分的变化

指标类型：

主要指标

Outcome：

Assess changes in dyspnea and quality of life score

Type：

Primary indicator

测量时间点：

基线、治疗后的第2周、4周、8周、12周各评价一次

测量方法：

加州大学圣地亚哥分校呼吸困难问卷(UCSD-SOBQ)

Measure time point of outcome：

Evaluation was performed at baseline, 2, 4, 8, and 12 weeks after treatment

Measure method：

The University of California in San Diego (UCSD) Shortness of Breath Questionnaire (SOBQ)

指标中文名：

评估咳嗽及对生活质量影响评分的变化

指标类型：

主要指标

Outcome：

Assess cough and change in quality of life score

Type：

Primary indicator

测量时间点：

基线、治疗后的第2周、4周、8周、12周各评价一次

测量方法：

莱塞斯特咳嗽生命质量问卷

Measure time point of outcome：

Evaluation was performed at baseline, 2, 4, 8, and 12 weeks after treatment

Measure method：

Leicester Cough Quality of Life Questionnaire

指标中文名：

移植或非选择性呼吸系统原因住院

指标类型：

次要指标

Outcome：

Hospitalization for transplant or non-selective respiratory reasons

Type：

Secondary indicator

测量时间点：

12周内

测量方法：

Measure time point of outcome：

12 weeks

Measure method：

指标中文名：

急性加重

指标类型：

次要指标

Outcome：

Acute exacerbations

Type：

Secondary indicator

测量时间点：

12周内

测量方法：

Measure time point of outcome：

12 weeks

Measure method：

指标中文名：

中医证候积分

指标类型：

次要指标

Outcome：

Traditional Chinese medicine symptom score

Type：

Secondary indicator

测量时间点：

基线、治疗后的第2周、4周、8周、12周各评价一次

测量方法：

Measure time point of outcome：

Evaluation was performed at baseline, 2, 4, 8, and 12 weeks after treatment

Measure method：

指标中文名：

6分钟步行试验

指标类型：

次要指标

Outcome：

The six-minute-walking distance

Type：

Secondary indicator

测量时间点：

基线、治疗后的第2周、4周、12周各评价一次

测量方法：

Measure time point of outcome：

Evaluation was performed at baseline, 2, 4, and 12 weeks after treatment

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

None

Tissue：

人体标本去向

其它

说明

Fate of sample 

Others

Note：

征募研究对象情况：

正在进行

Recruiting

年龄范围：

最小 18 岁
Min age years
最大 80 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）：

采用区组随机化方法，按1:1的比例随机分为治疗组和对照组。采用SAS统计软件，给定种子数，产生受试者所接受处理的随机安排，列出流水号所对应的治疗分配，制作随机方案和随机信封，通过随机信封的方式对受试者进行随机。

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

Using block randomization method, the patients were randomly divided into treatment group and control group in a ratio of 1:1. SAS statistical software was used to generate the random arrangement of the treatment received by the subjects with the given number of seeds, list the treatment allocation correspondin

盲法：

双盲。

Blinding：

Double blind.

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）：

研究人员的邮箱；ResMan。

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

The email of researchers; ResMan.

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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