ChiCTR2400084044 版本V1.1 版本创建时间2025/05/26 14:42:40 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

ChiCTR2400084044 

最近更新日期：

Date of Last Refreshed on：

2024-05-09 15:44:56 

注册时间：

Date of Registration：

2024-05-09 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

牛黄上清胶囊治疗寻常痤疮的有效性和安全性多中心、随机、双盲、安慰剂平行对照临床试验

Public title：

A multicenter, randomized, double-blind, placebo-controlled parallel controlled clinical trial on the efficacy and safety of Niuhuang Shangqing Capsules in the treatment of acne vulgaris

注册题目简写：

English Acronym：

研究课题的正式科学名称：

牛黄上清胶囊治疗寻常痤疮的有效性和安全性多中心、随机、双盲、安慰剂平行对照临床试验

Scientific title：

A multicenter, randomized, double-blind, placebo-controlled parallel controlled clinical trial on the efficacy and safety of Niuhuang Shangqing Capsules in the treatment of acne vulgaris

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：

洪亦超 

研究负责人：

周冬梅 

Applicant：

Hong Yichao 

Study leader：

Zhou Dongmei 

申请注册联系人电话：

Applicant telephone：

+86 178 1687 4895

研究负责人电话：

Study leader's telephone：

+86 138 1120 1580

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：

hongyc@conbapharm.com

研究负责人电子邮件：

Study leader's E-mail：

52176857@163.com

申请单位网址(自愿提供)：

Applicant 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：

江西省上饶市弋阳县工业园区道口小区19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：

No. 19, Daokou Community, Industrial Park, Yiyang County, Shangrao City, Jiangxi Province

Study leader's address：

No. 23, Back Street of Art Museum, 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：

江西康恩贝中药有限公司

Applicant's institution：

Jiangxi Kang'enbei Traditional Chinese Medicine Co., Ltd

研究负责人所在单位：

首都医科大学附属北京中医医院

Affiliation of the Leader：

Beijing Traditional Chinese Medicine Hospital Affiliated to Capital Medical University

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

2024BL01-005-02

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件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 Traditional Chinese Medicine Hospital Affiliated to Capital Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

2024-04-05 00:00:00

伦理委员会联系人：

王晶

Contact Name of the ethic committee：

Wang Jing

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：

No. 23, Back Street of Art Museum, Dongcheng District, Beijing

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 10 8790 6734

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 Traditional Chinese Medicine Hospital 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：

No. 23, Back Street of Art Museum, 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：

北京市东城区美术馆后街23号

Institution
hospital：

Beijing Traditional Chinese Medicine Hospital Affiliated to Capital Medical University

Address：

No. 23, Back Street of Art Museum, Dongcheng District, Beijing

经费或物资来源：

江西康恩贝中药有限公司

Source(s) of funding：

Jiangxi Kang'enbei Traditional Chinese Medicine Co., Ltd

Target disease：

acne vulgaris

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 探索性研究/预试验 

Study phase：

0

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

主要研究目的 评价牛黄上清胶囊治疗肺经风热或脾胃湿热所致的寻常痤疮（Ⅱ级、Ⅲ级）的有效性。 次要研究目的 评价牛黄上清胶囊治疗肺经风热或脾胃湿热所致的寻常痤疮（Ⅱ级、Ⅲ级）的安全性。  

Objectives of Study：

Main research objectives Evaluate the effectiveness of Niuhuang Shangqing Capsules in the treatment of acne vulgaris (grade II and III) caused by lung meridian wind heat or spleen and stomach damp heat. Secondary research objectives Evaluate the safety of Niuhuang Shangqing Capsules in the treatment of acne vulgaris (grade II and III) caused by lung meridian wind heat or spleen and stomach damp heat.

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18~45周岁，男女不限； (2) 基线期研究者总体评估（IGA）为2级（轻度，比1级严重；有一些非炎性皮损，且仅有少数炎性皮损（仅为丘疹/脓疱，没有结节性皮损））或3级（中度，比2级严重；有较多非炎性皮损，并且可能有一些炎性皮损，但小的结节性皮损不超过1个）者； (3) 根据Pillsbury国际改良分类法，临床诊断为寻常痤疮Ⅱ级（有粉刺，中等量丘疹和脓疱，总病灶数在31-50个之间）或Ⅲ级（大量丘疹和脓疱，偶见大的炎性皮损，分布广泛，总病灶数在51-100个之间，结节/囊肿＜3个）的患者； (4) 符合中医证候诊断标准的肺经风热证（主症：皮损以红色或皮色丘疹、粉刺为主，或有痒痛。次症：大便秘结，小便短赤，口渴喜饮；舌脉：舌边尖红，苔薄黄，脉浮数或脉数。具备主症及次症2项以上者可诊断为肺经风热证）或脾胃湿热证（主症：皮损以红色丘疹、脓疱为主，有疼痛，面部、胸部、背部皮肤油腻。次症：可伴口臭、口苦，纳呆，便溏或粘滞不爽或便秘，尿黄；舌红苔黄腻，脉滑或弦。具备主症及次症2项以上者可诊断为脾胃湿热证）寻常痤疮患者； (5) 自愿参加临床试验并签署知情同意书，能够自觉遵守本试验方案，坚持用药，按时复诊，具有较好的依从性。

Inclusion criteria

(1) Age range from 18 to 45 years old, regardless of gender; (2) The baseline investigator's overall assessment (IGA) is level 2 (mild, more severe than level 1; there are some non inflammatory skin lesions with only a few inflammatory skin lesions (only papules/pustules, no nodular skin lesions) or level 3 (moderate, more severe than level 2; there are more non inflammatory skin lesions, and there may be some inflammatory skin lesions, but no more than one small nodular skin lesion); (3) According to the Pillsbury International Modified Classification, patients clinically diagnosed with acne vulgaris grade II (with acne, moderate papules and pustules, total lesions between 31-50) or grade III (with numerous papules and pustules, occasional large inflammatory lesions, widely distributed, total lesions between 51-100, nodules/cysts<3); (4) The lung meridian wind heat syndrome that meets the diagnostic criteria of traditional Chinese medicine (main symptoms: skin lesions are mainly red or skin colored papules, acne, or itching and pain. Secondary symptoms: constipation, short and red urine, thirsty and fond of drinking; tongue and pulse: sharp red tongue edge, thin and yellow coating, floating pulse or pulse number. Those with two or more main symptoms and secondary symptoms can be diagnosed as lung meridian wind heat syndrome) or spleen and stomach damp heat syndrome (main symptoms: skin lesions are mainly red papules and pustules, with pain, greasy skin on the face, chest, and back. Secondary symptoms: may be accompanied by bad breath, bitter taste, numbness, loose stools or sticky discomfort. Constipation, yellow urine; red tongue and greasy coating, smooth or stringy pulse. Patients with two or more main and secondary symptoms can be diagnosed as spleen and stomach damp heat syndrome) acne vulgaris patients; (5) Voluntarily participating in clinical trials and signing informed consent forms, able to consciously abide by the trial protocol, adhere to medication, receive timely follow-up visits, and have good compliance.

排除标准：

(1) 患有暴发性痤疮、聚合性痤疮、药物性痤疮（相关药物包括糖皮质激素、神经精神药物、抗结核药物、免疫调节剂、小分子靶向药等）、职业性痤疮及其他特殊类型的痤疮者； (2) 需要抗雄激素治疗（包括雌激素、孕激素、螺内酯及胰岛素增敏剂等）的痤疮患者，或符合中医证候诊断标准的冲任不调证患者； (3) 面部并发其他明显的可能影响有效性与安全性评价的皮肤疾病（如日光性皮炎、激素依赖性皮炎、玫瑰痤疮、银屑病、湿疹、脂溢性皮炎等）者； (4) 筛选时患有局限性肠炎或炎性肠病（如溃疡性结肠炎、假膜性结肠炎、慢性腹泻，或与抗生素有关的结肠炎、血性腹泻等）或有相关病史者； (5) 有多囊卵巢综合征（PCOS）病史的女性患者； (6) 首次用药前2周内面部局部外用过氧化苯甲酰、抗生素类（如红霉素、林可霉素、克林霉素、氯霉素、夫西地酸及莫匹罗星等）、壬二酸、硫磺、水杨酸以及中药外治疗法等治疗痤疮者； (7) 首次用药前4周内面部局部外用维A酸类药物（包括他扎罗汀、阿达帕林、维A酸、异维A酸等）治疗痤疮者，或进行过光电治疗、磨削或化学剥脱等物理、化学疗法治疗痤疮者； (8) 首次用药前4周内使用过抗生素类、皮质类固醇等系统性抗痤疮治疗者； (9) 首次用药前12周内使用过维A酸类系统性抗痤疮治疗者； (10) 首次用药前4周内使用过经研究者判定对寻常痤疮有影响的系统用中药制剂； (11) 患有恶性肿瘤以及患有心脑血管、呼吸、内分泌、代谢、风湿免疫、血液系统等严重原发性疾病或精神类疾病导致研究者认为不适合参加本临床试验者； (12) 严重的肝肾疾病，血清AST、ALT超过正常值范围上限的2倍，或Cr超过正常值范围上限的1.5倍者； (13) 已知对试验药物中任何成分过敏者，或过敏体质且经研究者评估不适合参加本试验者； (14) 妊娠、哺乳期女性； (15) 首次给药前2周内发生过无保护性行为的女性； (16) 首次给药前2周至研究结束时有生育计划，不愿采取有效的物理避孕措施（如避孕套、子宫内节育器、避孕环、结扎、禁欲等，安全期避孕法不包含在内）进行避孕（包括受试者伴侣）者，或计划捐精捐卵者； (17) 目前正在参加其他临床试验或首次给药前1个月内参加过其他临床试验者； (18) 试验期间不能禁酒者； (19) 研究者认为任何其他可能妨碍依从性、妨碍完成研究、损害受试者健康或干扰研究结局的情况，经研究者判断不适合参加本试验者。

Exclusion criteria：

(1) Individuals with eruptive acne, aggregative acne, drug-induced acne (including corticosteroids, neuropsychiatric drugs, anti tuberculosis drugs, immunomodulators, small molecule targeted drugs, etc.), occupational acne, and other special types of acne; (2) Acne patients who require anti androgen treatment (including estrogen, progesterone, spironolactone, and insulin sensitizers, etc.), or patients with Chongren syndrome who meet the diagnostic criteria of traditional Chinese medicine syndrome; (3) Facial complications with other skin diseases that may affect the efficacy and safety evaluation, such as sunburn dermatitis, hormone dependent dermatitis, rosacea, psoriasis, eczema, seborrheic dermatitis, etc; (4) Individuals with localized enteritis or inflammatory bowel disease (such as ulcerative colitis, pseudomembranous colitis, chronic diarrhea, or antibiotic related colitis, bloody diarrhea, etc.) or a history of related illnesses during screening; (5) Female patients with a history of polycystic ovary syndrome (PCOS); (6) Within 2 weeks prior to the first medication, topical topical treatments such as benzoyl peroxide, antibiotics (such as erythromycin, lincomycin, clindamycin, chloramphenicol, fusidic acid, and mospirocin), azelaic acid, sulfur, salicylic acid, and traditional Chinese medicine were used to treat acne on the face; (7) Individuals who have been treated with topical retinoids (including tazarotene, adapalene, retinoic acid, isotretinoic acid, etc.) on the face within 4 weeks prior to the first medication, or who have undergone physical and chemical therapies such as phototherapy, grinding, or chemical exfoliation to treat acne; (8) Individuals who have used systemic anti acne treatments such as antibiotics and corticosteroids within 4 weeks prior to their first medication; (9) Individuals who have used systemic anti acne treatment with retinoids within 12 weeks prior to their first medication; (10) Systemic traditional Chinese medicine preparations that have been determined by researchers to have an impact on acne vulgaris have been used within 4 weeks prior to the first medication; (11) Individuals who suffer from malignant tumors, as well as serious primary diseases such as cardiovascular, cerebrovascular, respiratory, endocrine, metabolic, rheumatic, immune, and hematological systems, or mental illnesses that the researcher deems unsuitable to participate in this clinical trial; (12) Severe liver and kidney diseases, with serum AST and ALT exceeding 2 times the upper limit of the normal range, or Cr exceeding 1.5 times the upper limit of the normal range; (13) Individuals who are known to be allergic to any component of the investigational drug, or have an allergic constitution and have been assessed by the researcher as unsuitable to participate in this trial; (14) Pregnant and lactating women; (15) Women who have engaged in unprotected sexual activity within 2 weeks prior to the first administration of medication; (16) Individuals who have a fertility plan from 2 weeks before the first administration to the end of the study and are unwilling to use effective physical contraception measures (such as condoms, intrauterine devices, contraceptive rings, ligatures, abstinence, etc., not included in the safe period contraception method) for contraception (including the subject's partner), or those who plan to donate sperm and eggs; (17) Those who are currently participating in other clinical trials or have participated in other clinical trials within one month before the first administration; (18) Those who cannot abstain from alcohol during the experiment; (19) The researcher believes that any other circumstances that may hinder compliance, hinder the completion of the study, harm the health of the subjects, or interfere with the study outcomes are deemed unsuitable for participation in this trial by the researcher.

研究实施时间：

Study execute time：

从 From 2024-02-01 00:00:00至 To 2025-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2024-05-16 00:00:00 至 To 2025-01-31 00:00:00  

干预措施：

Interventions：

组别：

安慰剂对照

样本量：

100

Group：

placebo control

Sample size：

干预措施：

符合入选条件的受试者随机分配进入对照组，对照组服用牛黄上清胶囊模拟剂。牛黄上清胶囊模拟剂口服，一次3粒，一日2次，连续服用28天。

干预措施代码：

Intervention：

Subjects who meet the selection criteria will be randomly assigned to the control group, which will receive a simulated dose of Niuhuang Shangqing Capsules. Oral administration of Niuhuang Shangqing Capsule Simulator, 3 capsules per dose, 2 times a day, for 28 consecutive days.

Intervention code：

组别：

试验组

样本量：

100

Group：

Experimental group

Sample size：

干预措施：

符合入选条件的受试者随机分配进入试验组，试验组服用牛黄上清胶囊。牛黄上清胶囊口服，一次3粒，一日2次，连续服用28天。

干预措施代码：

Intervention：

Subjects who meet the selection criteria are randomly assigned to the experimental group, which takes Niuhuang Shangqing capsules. Niuhuang Shangqing Capsules are taken orally, taking 3 capsules at a time, twice a day, for 28 consecutive days.

Intervention code：

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：

 

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 Traditional Chinese Medicine Hospital Affiliated to Capital Medical University

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 河北省 

市(区县)：

 石家庄 

Country：

China 

Province：

Hebei 

City：

 

单位(医院)：

河北省中医院  

单位级别：

三甲 

Institution
hospital：

Hebei Provincial Hospital of Traditional Chinese Medicine

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 江西省 

市(区县)：

 南昌市 

Country：

China 

Province：

Jiangxi 

City：

 

单位(医院)：

江西省中西医结合医院 

单位级别：

三甲 

Institution
hospital：

Jiangxi Province Integrated Traditional Chinese and Western Medicine Hospital

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 江苏省 

市(区县)：

 盐城 

Country：

China 

Province：

Jiangsu 

City：

 

单位(医院)：

盐城市第一人民医院 

单位级别：

三甲 

Institution
hospital：

Yancheng First People's Hospital

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 河北省 

市(区县)：

 石家庄 

Country：

China 

Province：

Hebei 

City：

 

单位(医院)：

石家庄市中医院 

单位级别：

三甲 

Institution
hospital：

Shijiazhuang Traditional Chinese Medicine Hospital

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 浙江省 

市(区县)：

 温州 

Country：

China 

Province：

Zhejiang 

City：

 

单位(医院)：

温州市中西医结合医院 

单位级别：

三甲 

Institution
hospital：

Wenzhou Integrated Traditional Chinese and Western Medicine Hospital

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 浙江省 

市(区县)：

 杭州 

Country：

China 

Province：

Zhejiang 

City：

 

单位(医院)：

杭州市第三人民医院 

单位级别：

三甲 

Institution
hospital：

Hangzhou Third People's Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

治疗结束时（第28天），各组受试者的总皮损计数较基线变化的百分比

指标类型：

主要指标

Outcome：

At the end of treatment (day 28), the percentage change in total skin lesion count from baseline for each group of subjects

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

治疗至第14天时，各组受试者的总皮损计数较基线变化的百分比

指标类型：

次要指标

Outcome：

The percentage change in total skin lesion count from baseline for each group of subjects until the 14th day of treatment

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

治疗至第14、28天时，各组受试者炎性皮损计数、非炎性皮损计数和总皮损计数较基线数值的变化

指标类型：

次要指标

Outcome：

Changes in inflammatory skin lesion count, non inflammatory skin lesion count, and total skin lesion count from baseline in each group of subjects until the 14th and 28th day of treatment

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

治疗至第14、28天时，各组IGA评分为0（清除）和IGA评分为1（轻度）的受试者比率

指标类型：

次要指标

Outcome：

Ratio of subjects with IGA scores of 0 (cleared) and 1 (mild) in each group at day 14 and 28 of treatment

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

治疗至第14、28天时，各组中医皮损症状（皮损类型、数量、颜色、瘙痒、疼痛等）评分，计算中医皮损症状疗效指数及总有效率

指标类型：

次要指标

Outcome：

At the 14th and 28th day of treatment, the TCM skin lesion symptoms (type, quantity, color, itching, pain, etc.) of each group were scored, and the TCM skin lesion symptom efficacy index and total effective rate were calculated

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

治疗至第14、28天时，各组中医证候评分，计算中医证侯疗效指数及总有效率

指标类型：

次要指标

Outcome：

At the 14th and 28th day of treatment, the TCM syndrome scores of each group were evaluated, and the TCM syndrome efficacy index and total effective rate were calculated

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

治疗至第14、28天时，各组皮肤病生活质量指数（DLQI）评分

指标类型：

次要指标

Outcome：

At the 14th and 28th day of treatment, the DLQI scores for skin diseases in each group were evaluated

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

治疗至第28天时，IL-1、TNF-α检测值较基线数值的变化

指标类型：

次要指标

Outcome：

At the 28th day of treatment, IL-1 and TNF- α Changes in detection values compared to baseline values

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液

组织：

Sample Name：

blood

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

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

Fate of sample：

Destruction after use  

Note：

征募研究对象情况：

Recruiting status：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 45 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

本试验采用随机双盲的设计，以保证研究者、相关研究人员和受试者对试验分组的盲态。 本试验采用分层区组随机化方法，各中心竞争入组。以SAS软件（9.4或以上版本）产生随机表以及随机表所对应治疗组别，采用中央随机管理系统（CIMS-CRS）分配随机号。随机表（一级盲底）和二级盲底密封保存，一式二份，分别封存在申办者和临床研究负责单位。 筛选时，根据签署知情同意书的顺序分配筛选号识别受试者，以S+2位中心号+3位阿拉伯数字表示，如S01001、S01002、S01003……。试验的第-1天进行随机。筛选及入组检查合格的受试者将通过中央随机系统系统获得1个未重复的随机号和2个药物编号。受试者随机号以R001~R400表示，药物包装号以D001~D600表示。

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

This experiment adopts a randomized double-blind design to ensure that researchers, relevant researchers, and subjects are blinded to the experimental grouping. This experiment adopts a stratified block randomization method, with each center competing for enrollment. Generate a randomization table using SAS software (version 9.4 or above) and the corresponding treatment groups for the randomization table, and assign a randomization number using the Central Randomization Management System (CIMS-CRS). Two copies of the random table (first level blind base) and second level blind base shall be sealed and stored, respectively, by the applicant and the clinical research unit. When screening, assign a screening number to identify the subjects in the order of signing the informed consent form, represented by S+2 center numbers+3 Arabic numerals, such as S01001, S01002, S01003, etc. Randomize on the first day of the experiment. Subjects who pass the screening and enrollment examination will receive one non repeated random number and two drug numbers through the central randomization system. The subject's random number is represented by R001~R400, and the drug packaging number is represented by D001~D600.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

双盲，对研究者、相关研究人员和受试者施盲。

Blinding：

Double blind, blinding researchers, relevant researchers, and subjects.

是否共享原始数据：

IPD sharing

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）：

无

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

none

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

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2024-05-09 15:44:38