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补肺活血胶囊治疗慢性阻塞性肺疾病稳定期重度患者的临床研究

注册号：

Registration number：

ITMCTR2025001111

最近更新日期：

Date of Last Refreshed on：

2025-06-03

注册时间：

Date of Registration：

2025-06-03

注册号状态：

Registration Status：

补注册

Retrospective registration

注册题目：

补肺活血胶囊治疗慢性阻塞性肺疾病稳定期重度患者的临床研究

Public title：

Clinical study of Bufei-Huoxue capsule in the treatment of severe patients with stable chronic obstructive pulmonary disease

注册题目简写：

补肺治疗COPD稳定期重度患者的临床研究

English Acronym：

Clinical study of BFHX capsule in the treatment of severe patients with stable COPD

研究课题的正式科学名称：

补肺活血胶囊治疗慢性阻塞性肺疾病稳定期重度患者的临床研究

Scientific title：

Clinical study of Bufei-Huoxue capsule in the treatment of severe patients with stable chronic obstructive pulmonary disease

研究课题的正式科学名称简写：

补肺活血胶囊治疗慢性阻塞性肺疾病稳定期重度患者的临床研究

Scientific title acronym：

Clinical study of Bufei-Huoxue capsule in the treatment of severe patients with stable chronic obstructive pulmonary disease

研究课题代号(代码)：

Study subject ID：

None

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：

None ;

申请注册联系人：

徐维国

研究负责人：

徐维国

Applicant：

Weiguo Xu

Study leader：

Weiguo Xu

申请注册联系人电话：

Applicant telephone：

+86 189 8110 8027

研究负责人电话：

Study leader's telephone：

+86 189 8110 8027

申请注册联系人传真 ：

Applicant Fax：

无

研究负责人传真：

Study leader's fax：

无

申请注册联系人电子邮件：

Applicant E-mail：

954830595@qq.com

研究负责人电子邮件：

Study leader's E-mail：

xwg522630@126.com

申请单位网址(自愿提供)：

Study leader's website(voluntary supply)：

https://www.myszxyy.cn/

研究负责人网址(自愿提供)：

Study leader's website
(voluntary supply)：

https://www.myszxyy.cn/

申请注册联系人通讯地址：

四川省绵阳市警钟街常家巷12号

研究负责人通讯地址：

四川省绵阳市警钟街常家巷12号

Applicant address：

12 Changjia Lane Alarm Street Mianyang City Sichuan Province

Study leader's address：

12 Changjia Lane Alarm Street Mianyang City Sichuan Province

申请注册联系人邮政编码：

Applicant postcode：

621000

研究负责人邮政编码：

Study leader's postcode：

621000

申请人所在单位：

绵阳市中心医院

Applicant's institution：

Mianyang Central Hospital

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：

S202403194-01

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：

绵阳市中心医院伦理委员会

Name of the ethic committee：

Ethics Committee of Mianyang Central Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

2024/12/6 0:00:00

伦理委员会联系人：

李琳

Contact Name of the ethic committee：

Lin Li

伦理委员会联系地址：

四川省绵阳市涪城区常家巷12号

Contact Address of the ethic committee：

12 Changjia Lane Fucheng District Mianyang City Sichuan Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 816 223 7206

伦理委员会联系人邮箱：

Contact email of the ethic committee：

myszxyylcsyll@163.com

研究实施负责（组长）单位：

绵阳市中心医院

Primary sponsor：

Mianyang Central Hospital

研究实施负责（组长）单位地址：

四川省绵阳市警钟街常家巷12号

Primary sponsor's address：

12 Changjia Lane Alarm Street Mianyang City Sichuan 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)：

广东

市(区县)：

云浮

Country：

China

Province：

Guangdong

City：

Yunfu

单位(医院)：

广东雷允上药业有限公司

具体地址：

广东省云浮市云安区都杨镇佛山云浮产业转移工业园60号地

Institution
hospital：

Guangdong Leyunshang Pharmaceutical Co. LTD

Address：

No.60 Foshan Yunfu Industrial Transfer Industrial Park Duyang Town Yunan District Yunfu City Guangdong Province

经费或物资来源：

广东雷允上药业有限公司

Source(s) of funding：

Guangdong Leyunshang Pharmaceutical Co. LTD

研究疾病：

慢性阻塞性肺疾病

研究疾病代码：

076

Target disease：

Chronic obstructive pulmonary 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：

上市后药物

Post-marketing clinical trial

研究目的：

评价补肺活血胶囊治疗慢性阻塞性肺疾病稳定期重度患者临床的安全性和有效性。

Objectives of Study：

To evaluate the safety and efficacy of Bufei-Huoxue capsule in the treatment of severe patients with stable chronic obstructive pulmonary disease (COPD).

药物成份或治疗方案详述：

补肺活血胶囊成份组成：由黄芪、赤芍、补骨脂三味药材组成。 本研究治疗方案设计如下： 1、采用随机、双盲、对照临床研究方法。 （1）随机：本研究计划用SAS9.4统计软件产生随机编码，采用随机数表的方法，将受试者按1 : 1的比例随机分配到试验组或对照组。独立于本试验的第三方统计编盲人员将根据药物随机编号对试验用药进行编盲，各中心药物管理人员根据相应药物编号将试验药物分发给受试者。 （2）试验组：补肺活血胶囊，每日3次，每次4粒（0.35g/粒），口服； （3）对照组：补肺活血胶囊模拟剂，每日3次，每次4粒（0.35g/粒），口服； （4）疗程：24周。受试者从入组当天（第1天，V0）开始服药，连续服用24周，设置四个访视点：基线（V0）、访视1（V1）、访视2（V2）、访视3（V3），即基线、第4周、第12周、第24周。 （5）时间窗：访视1（V1）为±3天；访视2（V2）和访视3（V3）为±7天。 （6）拟纳入病例共214例。

Description for medicine or protocol of treatment in detail：

Bufei Huoxue capsule is a third class of new Chinese medicine approved for listing in 2003 (Z20030063). It is the first therapeutic drug to be included in the "nourishing cardiopulmonary" category by China's medical insurance catalogue and entered the 2018 edition of the National Essential Drug catalogue (internal medicine - removing stasis agent) which belongs to the double-advantage varieties of medical insurance and basic drugs. Bufei Huoxue capsule has been on the market for more than ten years and it has good efficacy and high safety in the clinical treatment of chronic respiratory diseases such as chronic pulmonary heart disease. The prescription is composed of three medicinal materials: Astragalus membranaceus Paeonia lactiflora and Psoralea corylifolia. Functions: Tonifying qi and activating blood tonifying lung and reinforcing kidney. It is suitable for treating the syndrome of Qi deficiency and blood stasis in stable stage of chronic obstructive pulmonary disease. The treatment plan of this study is designed as follows: 1. Randomized double-blind controlled clinical study method was adopted. (1) Randomization: This study plans to use SAS9.4 statistical software to generate random codes and adopt the method of random number table to randomly assign subjects to the test group or the control group according to a ratio of 1:1. A third party statistical blinder independent of the study will encode the experimental drugs according to the random drug number and drug management personnel in each center will distribute the experimental drugs to the subjects according to the corresponding drug number. (2) Experimental group: Bufei Huoxue capsule 4 capsules (0.35g/ capsule) 3 times a day orally; (3) Control group: simulation agent of Bufei Huoxue capsule 4 capsules (0.35g/ capsule) 3 times a day orally; (4) Duration: 24 weeks. Subjects began to take the medication from the day of enrollment (day 1 V0) for 24 consecutive weeks and four visit points were set: baseline (V0) visit 1 (V1) visit 2 (V2) visit 3 (V3) namely baseline week 4 week 12 and week 24. (5) Time window: Interview 1 (V1) was ±3 days; Interview 2 (V2) and interview 3 (V3) were ±7 days. (6) A total of 214 cases were intended to be included. 2. Basis for dose selection Because the drugs involved in the test group and the control group are all drugs already on the market the routine recommended dosage is according to the instruction manual. 3. Basis for sample size calculation Based on the data of the preliminary study on Bufei Huoxue capsule in the treatment of chronic obstructive pulmonary disease in the stable period after treatment the difference of 6-minute walking distance between the two groups in the 24th week compared with the baseline was respectively 31.04 ± 43.10 in the experimental group and 7.14 ± 50.59 in the control group and the proportion of sample size between the two groups was 1 according to α which was unilateral 0.025. 1. The statistical efficacy was 85% (β was 0.15). Using PASS 11.0 to calculate the sample size of 85 cases in the experimental group and 85 cases in the control group taking into account a certain shedding rate the sample size was appropriately enlarged to determine the sample size of 214 cases including 107 cases in the experimental group and 107 cases in the control group. 4. Definition of the end of the study Subjects are considered to have completed the study if they have completed all phases of the study including the final visit or the last planning procedure listed in the study schedule.

纳入标准：

纳入标准 1)年龄40～80周岁（含40周岁和80周岁），性别不限； 2)符合慢性阻塞性肺疾病（COPD）诊断，筛选时处于慢性阻塞性肺疾病稳定期（指患者咳嗽、咳痰、气短等症状稳定或症状轻微且近4周内无急性加重）； 3)筛选时吸入硫酸沙丁胺醇400μg后15~25分钟测定，FEV1/ FVC＜70%且20%≤FEV1占预期值%＜50%； 4)症状水平CAT≥10分，mMRC≥2级，过去1年中0~1次中度急性加重且不导致入院（B组）；或过去一年中≥2次中度急性加重或1次导致入院的急性加重（E组）； 5)中医辨证为气虚血瘀证； 6)自愿参加本项临床试验，知情同意并签署知情同意书。

Inclusion criteria

Inclusion Criteria 1) Age 40-80 years old (including 40 years old and 80 years old) regardless of gender; 2) patients met the diagnosis of chronic obstructive pulmonary disease (COPD) and were in stable phase of COPD at the time of screening (patients with stable or mild symptoms such as cough expectoration and shortness of breath without acute exacerbation in the past 4 weeks); 3) FEV1/ FVC < 70% and 20%≤ FEV1% predicted < 50% measured 15-25 minutes after inhalation of albuterol sulfate 400μg at screening; 4) symptom level CAT≥10 mMRC≥2 0-1 moderate acute exacerbation in the past year that did not lead to admission (group B); Or ≥2 moderate acute exacerbations or 1 acute exacerbation leading to hospital admission in the previous year (group E); 5) Qi deficiency and blood stasis syndrome; 6) voluntarily participated in this clinical trial informed consent and signed informed consent form.

排除标准：

排除标准 1）合并有哮喘、活动性肺结核病、肺癌、弥漫性泛细支气管炎、肺切除、肺减容术（12个月内）、严重支气管扩张症、原发性肺间质性疾病、原发性肺纤维化、原发性肺动脉高压、呼吸衰竭或其他活动性肺脏疾病； 2）合并严重的消化系统、内分泌系统、神经系统疾病、自身免疫性疾病或其他疾病，如严重甲状腺功能亢进，研究者判断影响受试者入组后的有效性、安全性评价或依从性； 3）肝功能指标（ALT、AST）中任一项超过正常参考值上限，肾功能指标Scr超过正常参考值上限1.2倍； 4）本身合并严重肝脏疾病（如肝脏肿瘤、肝硬化、各种类型肝炎等）或既往有药物性肝损伤病史，以及正在使用或本研究期间预期使用具有潜在肝损害作用的药物（免疫抑制剂如环孢素、他克莫司等，抗结核药如利福平、异烟肼等，化疗药如环磷酰胺、甲氨蝶呤、硫唑嘌呤等；针对高胆固醇血症或缺血性心脏脑血管疾病等治疗的他汀类药物以及含何首乌、土三七、雷公藤等肝损害药材的中药）； 5）试验前1年内有酒精、药物滥用史； 6）对试验药物及其辅料或应急药物有过敏史； 7）有智力障碍或精神障碍或认知障碍； 8）妊娠、哺乳期妇女，计划怀孕或不能采用有效的避孕措施； 9）筛选前30天或5个半衰期内（以较长者为准）内参与过任何临床试验； 10）合并其他绝对或相对禁止6分钟步行试验的情况：如静息状态心率＞120次/分，收缩压＞180mmHg和舒张压＞100mmHg；或下肢活动受限难以完成6分钟步行试验； 11）在筛选期间需要住院和/或抗生素治疗和/或口服或静脉激素治疗；或试验期间需要长期使用氧疗（＞12个小时/天）； 12）研究者认为不适宜参加本临床试验。

Exclusion criteria：

Exclusion Criteria 1) combined with asthma active pulmonary tuberculosis lung cancer diffuse panbronchiolitis pneumonectomy lung volume reduction surgery (within 12 months) severe bronchiectasis primary interstitial lung disease primary pulmonary fibrosis primary pulmonary hypertension respiratory failure or other active lung diseases; 2) combined with severe diseases of the digestive system endocrine system nervous system autoimmune disease or other diseases such as severe hyperthyroidism which will affect the effectiveness safety evaluation or compliance of the subjects after enrollment according to the investigator's judgment; 3) any one of the liver function indexes (ALT AST) exceeded the upper limit of normal reference value and the renal function index Scr exceeded 1.2 times the upper limit of normal reference value; 4) patients with severe liver diseases (such as liver tumors cirrhosis various types of hepatitis etc.) or previous history of drug-induced liver injury and current use or expected use of drugs with potential liver damage (immunosuppressants such as cyclosporine tacrolimus etc. anti-tuberculosis drugs such as rifampicin isoniazid etc.) during the study period; Chemotherapy drugs such as cyclophosphamide methotrexate azathioprine etc. Statins for the treatment of hypercholesterolemia or ischemic cardiovascular and cerebrovascular diseases and traditional Chinese medicine containing polygonum multiflorum Gysanqi tripterygium wilfordii and other liver damage herbs); 5) had a history of alcohol or drug abuse within 1 year before the test; 6) have a history of allergy to the trial drug and its excipients or emergency drugs; 7) have intellectual or mental retardation or cognitive impairment; 8) pregnant or lactating women who plan to become pregnant or are unable to use effective contraception; 9) have participated in any clinical trial within 30 days or 5 half-lives (whichever is longer) before screening; 10) other conditions that absolutely or relatively prohibit the 6-minute walk test such as resting heart rate > 120 beats/min systolic blood pressure > 180mmHg and diastolic blood pressure > 100 MMHG; Or difficulty completing a 6-minute walk test due to limited movement of the lower limbs; 11) requiring hospitalization and/or antibiotic treatment and/or oral or intravenous hormone therapy during screening; Long-term oxygen therapy (> 12 hours per day) was required during the trial; 12) were deemed inappropriate by the investigator to participate in the trial.

研究实施时间：

Study execute time：

从From 2024-09-01

至To      2028-12-13

征募观察对象时间：

Recruiting time：

从From 2025-03-13

至To      2028-06-12

干预措施：

Interventions：

组别：

试验组

样本量：

107

Group：

Experimental group

Sample size：

干预措施：

试验组：补肺活血胶囊，每日3次，每次4粒（0.35g/粒），口服； 疗程：治疗期24周。

干预措施代码：

None

Intervention：

Experimental group: Bufei Huoxue capsule 4 capsules (0.35g/ capsule) 3 times a day orally; Treatment course: The treatment period was 24 weeks.

Intervention code：

组别：

对照组

样本量：

107

Group：

control group

Sample size：

干预措施：

对照组：补肺活血胶囊模拟剂，每日3次，每次4粒（0.35g/粒），口服； 疗程：治疗期24周。

干预措施代码：

None

Intervention：

Control group: simulation agent of Bufei Huoxue capsule, 4 capsules (0.35g/ capsule), 3 times a day, orally; Treatment course: The treatment period was 24 weeks.

Intervention code：

样本总量 Total sample size ： 214

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

四川

市(区县)：

绵阳

Country：

China

Province：

Sichuan

City：

Mianyang

单位(医院)：

绵阳市中心医院

单位级别：

三甲

Institution/hospital：

Mianyang Central Hospital

Level of the institution：

Tertiary A

国家：

中国

省(直辖市)：

四川

市(区县)：

绵阳

Country：

China

Province：

Sichuan

City：

Mianyang

单位(医院)：

绵阳市中医医院

单位级别：

三甲

Institution/hospital：

Mianyang Traditional Chinese Medicine Hospital

Level of the institution：

Tertiary A

国家：

中国

省(直辖市)：

四川

市(区县)：

德阳市

Country：

China

Province：

Sichuan

City：

Deyang

单位(医院)：

德阳市第六人民医院

单位级别：

二级

Institution/hospital：

The Sixth People's Hospital of Deyang City

Level of the institution：

Secondary

国家：

中国

省(直辖市)：

四川

市(区县)：

绵阳

Country：

China

Province：

Sichuan

City：

Mianyang

单位(医院)：

绵阳市第三人民医院

单位级别：

三甲

Institution/hospital：

Mianyang Third People's Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

（6）研究期间感冒、AECOPD发生情况。

指标类型：

次要指标

Outcome：

(6)The occurrence of cold and AECOPD during the study period.

Type：

Secondary indicator

测量时间点：

整个研究期间

测量方法：

观察和记录

Measure time point of outcome：

Throughout the study period

Measure method：

Observe and record

指标中文名：

(2)比较治疗后V3访视两组肺功能指标FVC、FEV1、FEV1/FVC较基线的变化；

指标类型：

次要指标

Outcome：

(2) The changes of pulmonary function indexes FVC, FEV1 and FEV1/FVC in the two groups after treatment were compared with the baseline;

Type：

Secondary indicator

测量时间点：

V3访视

测量方法：

肺功能检测

Measure time point of outcome：

V3

Measure method：

Pulmonary function test

指标中文名：

(3)比较治疗后V2、V3访视两组CAT评分、mMRC评分较基线的变化；

指标类型：

次要指标

Outcome：

(3) The changes of CAT score and mMRC score of V2 and V3 visits after treatment were compared with baseline;

Type：

Secondary indicator

测量时间点：

V2、V3访视

测量方法：

CAT评分量表、mMRC评分量表

Measure time point of outcome：

V2 and V3

Measure method：

CAT score table, mMRC score table

指标中文名：

(4)比较治疗后V2、V3访视两组中医证候评分较基线的变化；

指标类型：

次要指标

Outcome：

(4) The changes of TCM syndrome scores in V2 and V3 visits after treatment were compared with baseline;

Type：

Secondary indicator

测量时间点：

V2、V3访视

测量方法：

中医证候评分表

Measure time point of outcome：

V2 and V3

Measure method：

TCM syndrome score table

指标中文名：

两组治疗后第V2访视6分钟步行距离较基线的变化；

指标类型：

次要指标

Outcome：

(1) Changes in walking distance of 6 minutes at V2 visit after treatment compared with baseline in both groups;

Type：

Secondary indicator

测量时间点：

V2访视

测量方法：

到达6 min时，在受试者所在位置做1个标记。以走廊上的3 m标记作为距离指南，根据受试者行走的圈数及6MWT结束时标记的位置，以米为单位，计算步行的总距离。

Measure time point of outcome：

V2

Measure method：

When 6 minutes are reached, make a mark at the subject's location. Using the 3 m mark on the corridor as the distance guide, the total walking distance was calculated in meters according to the number of laps the subject walked and the position marked at the end of 6MWT.

指标中文名：

(5)比较治疗后V2、V3访视两组PHQ-9抑郁症筛查量表和GAD-7广泛性焦虑障碍量表评分较基线的变化；

指标类型：

次要指标

Outcome：

(5) The changes of PHQ-9 depression screening scale and GAD-7 Generalized Anxiety Disorder Scale scores from baseline were compared between V2 and V3 visits after treatment;

Type：

Secondary indicator

测量时间点：

V2、V3访视

测量方法：

PHQ-9抑郁症筛查量表和GAD-7广泛性焦虑障碍量表

Measure time point of outcome：

V2 and V3

Measure method：

PHQ-9 depression screening scale and GAD-7 generalized anxiety Disorder scale

指标中文名：

(1)两组治疗后，V3访视6分钟步行距离较基线的变化差异；

指标类型：

主要指标

Outcome：

(1) Changes in 6-minute walking distance at V3 visit compared with baseline between the two groups after treatment;

Type：

Primary indicator

测量时间点：

V3访视

测量方法：

到达6 min时，在受试者所在位置做1个标记。以走廊上的3 m标记作为距离指南，根据受试者行走的圈数及6MWT结束时标记的位置，以米为单位，计算步行的总距离。

Measure time point of outcome：

V3

Measure method：

When 6 minutes are reached make a mark at the subject's location. Using the 3 m mark on the corridor as the distance guide the total walking distance was calculated in meters according to the number of laps the subject walked and the position marked at the end of 6MWT.

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

无

Sample Name：

None

Tissue：

None

人体标本去向

其它

说明

无

Fate of sample 

Others

Note：

None

征募研究对象情况：

正在进行

Recruiting

年龄范围：

最小 40 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）：

用SAS9.4统计软件产生随机编码，采用随机数表的方法，将受试者按1 : 1的比例随机分配到试验组或对照组。独立于本试验的第三方统计编盲人员将根据药物随机编号对试验用药进行编盲，各中心药物管理人员根据相应药物编号将试验药物分发给受试者。

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

SAS9.4 statistical software was used to generate random codes and the subjects were randomly assigned to the test group or the control group according to a ratio of 1:1 by using a random number table. A third party statistical blinder independent of the study will encode the experimental drugs according to the random drug number and drug management personnel in each center will distribute the experimental drugs to the subjects according to the corresponding drug number.

盲法：

双盲：即研究者和受试者都不知道分组结果，研究者不知道哪个受试者被分配在哪组，受试者也不知道自己被施以何种干预措施‌

Blinding：

Double-blind: Neither the researcher nor the subjects were aware of the group assignments the researcher did not know which subjects were assigned to which group and the subjects did not know which intervention ‌

是否共享原始数据：

IPD sharing：

否

No

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）：

不共享

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

No share

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

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）：

试验未结束

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

The trial is not over.

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