ChiCTR2400085079 版本V1.0 版本创建时间2024/05/30 16:38:20 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：

ChiCTR2400085079 

最近更新日期：

Date of Last Refreshed on：

2024-05-30 16:38:12 

注册时间：

Date of Registration：

2024-05-30 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

芪丹益肺通窍颗粒治疗常年性持续性变应性鼻炎的 随机、双盲、安慰剂、平行对照临床研究

Public title：

A randomized, double-blind, placebo, parallel-controlled clinical study of Qidan Yifei Tongqiao Granules for the treatment of perennial persistent allergic rhinitis

注册题目简写：

English Acronym：

研究课题的正式科学名称：

芪丹益肺通窍颗粒治疗常年性持续性变应性鼻炎的 随机、双盲、安慰剂、平行对照临床研究

Scientific title：

A randomized, double-blind, placebo, parallel-controlled clinical study of Qidan Yifei Tongqiao Granules for the treatment of perennial persistent allergic rhinitis

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：

易欣 

研究负责人：

田理 

Applicant：

Xin Yi 

Study leader：

Li Tian 

申请注册联系人电话：

Applicant telephone：

+86 159 0286 2967

研究负责人电话：

Study leader's telephone：

+86 189 8088 0129

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：

724549594@qq.com

研究负责人电子邮件：

Study leader's E-mail：

18980880129@qq.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：

四川省成都市青羊区包家巷126号

研究负责人通讯地址：

四川省成都市金牛区十二桥路39号

Applicant address：

No.126, Baojiaxiang, Qingyang District, Chengdu, Sichuan Province, China

Study leader's address：

No.39, Shierqiao Road, Jinniu District, Chengdu, Sichuan, China

申请注册联系人邮政编码：

Applicant postcode：

610000

研究负责人邮政编码：

Study leader's postcode：

610072

申请人所在单位：

成都中医药大学

Applicant's institution：

Chengdu University of TCM

研究负责人所在单位：

成都中医药大学附属医院

Affiliation of the Leader：

Hospital of Chendu University of TCM

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：

2024KL-041

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：

成都中医药大学附属医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee, Hospital of Chengdu University of TCM

伦理委员会批准日期：

Date of approved by ethic committee：

2024-05-15 00:00:00

伦理委员会联系人：

何清

Contact Name of the ethic committee：

Qing He

伦理委员会联系地址：

四川省成都市金牛区十二桥路39号

Contact Address of the ethic committee：

No.39, Shierqiao Road, Jinniu District, Chengdu, Sichuan, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 28 8778 3142

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：

成都中医药大学附属医院

Primary sponsor：

Hospital of Chendu University of TCM

研究实施负责（组长）单位地址：

四川省成都市金牛区十二桥路39号

Primary sponsor's address：

No.39, Shierqiao Road, Jinniu District, Chengdu, Sichuan, 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)：

四川省

市(区县)：

Country：

China

Province：

Sichuan

City：

单位(医院)：

成都中医药大学附属医院

具体地址：

四川省成都市金牛区十二桥路39号

Institution
hospital：

Hospital of Chendu University of TCM

Address：

No.39, Shierqiao Road, Jinniu District, Chengdu, Sichuan, China

经费或物资来源：

四川省中医药院士后备培养项目

Source(s) of funding：

Sichuan Province Chinese Medicine Academician Reserve Training Program

Target disease：

Allergic rhinitis

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：

通过4周的治疗及4周的随访，评估1.QDYF_KL治疗常年性持续性AR的有效性及安全性，2.探索QDYF_KL调节常年性持续性AR伴随睡眠障碍、焦虑抑郁心理问题的有效性及中药药物优势，3.并初步探索其可能的作用机制。  

Objectives of Study：

The trial will accomplish the following with 4 weeks of treatment and 4 weeks of follow-up: 1. To assess the effectiveness and safety of QDYFTQ granules in treating perennial persistent AR.2. To explore the effectiveness of QDYFTQ granules in modulating perennial persistent AR accompanied by sleep disorders, anxiety and depressive psychological problems and the advantages of traditional Chinese medicine medication.3. To preliminarily explore the possible mechanism of its action.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

参与该试验研究的所有受试者需在筛选访视期（SV/V1）时，符合以下要求：（1）性别不限，男性或非妊娠/哺乳期女性；（2）受试者年龄在18-65周岁之间；（3）符合上述西医诊断标准；（4）符合中医辨证气虚风袭，瘀热相兼证型诊断标准；（5）受试者筛选访视（SV/V1）12小时内，鼻部症状“喷嚏、流涕、鼻塞、鼻痒”至少具备2项，鼻塞≥2分；（6）入组前12个月内，有终年性过敏原（如尘螨、蟑螂、猫皮屑、狗皮屑、霉菌等）检测阳性；（7）能独立完成量表，同意并自愿参加本次研究、签署知情同意书者。

Inclusion criteria

All participants in this trial study are required to meet the following requirements during the screening visit period (SV/V1) :(1) Any gender, male or non-pregnant/lactating female; (2) Subjects aged between 18-65 years old; (3) Subjects were required to meet the diagnostic criteria for TCM identification of qi deficiency and wind attack with stasis and heat; (4) Meets the diagnostic criteria of Chinese medicine tocriteria for TCM identification of qi deficiency and wind attack with stasis and heat ; (5) Within 12 hours of the subject's Screening Visit (SV/V1), the nasal symptom of "sneezing, runny nose, nasal congestion, nasal itch" has at least 2 items, and nasal congestion ≥ 2 points; (6) Has a terminal allergen (e.g.cockroach, cat dander, dog dander, mold) within 12 months prior to enrollment. " at least 2 items, nasal congestion ≥ 2 points; (6) within 12 months prior to enrollment, there was a positive test for terminal allergens (e.g., dust mites, cockroaches, cat dander, dog dander, molds, etc.); (7) those who were able to independently complete the scales, agreed to and voluntarily participated in the current study, and signed the informed consent form.

排除标准：

符合以下任一一项的受试者，均予以排除：（1）妊娠、哺乳期女性，或不愿在试验期间采取有效避孕措施者；（2）合并血管运动性鼻炎，药物性鼻炎，急性鼻-鼻窦炎，激素性鼻炎等；（3）合并支气管哮喘、咳嗽变异性哮喘等各类型哮喘；（4）合并严重鼻中隔偏曲、慢性鼻-鼻窦炎、鼻息肉、肥厚性鼻炎等鼻部器质性病变，在筛选访视（SV/V1）时由研究人员评估；（5）筛选访视（SV/V1）前，接受过变应原免疫最后一次治疗180天内，或6个月内接受过鼻部手术治疗、或4周内接受过大型手术治疗（由研究人员评估）；（6）筛选前180天内，使用舌下免疫治疗；120天内，使用IgE拮抗剂或任何抗IgE治疗，抗白介素-5治疗；60天内，全身性皮质类固醇治疗，免疫治疗注射和免疫抑制剂/免疫调节药物治疗；30天内，使用过所有鼻内/外用/眼部皮质类固醇药物，吸入型皮质类固醇激素，其他在研的非生物类药物，任何已知的强效CYP3A4诱导剂/抑制剂进行治疗；14天内，使用过所有形式的色甘酸钠、奈多罗米钠、洛度沙胺，全身性抗生素，肥大细胞膜稳定剂，单胺氧化酶抑制剂，三环类抗抑郁药治疗；10天内，使用过长效抗组胺药物治疗；7天内，使用过含有抗组胺剂的OTC止咳和感冒药或助眠药，局部/口服/鼻内减充血剂，白三烯拮抗剂或花生四烯酸5-脂氧合酶抑制剂，吸入/口服/鼻用抗胆碱能类药物，中药治疗及其它对AR有治疗作用的如针灸、穴位贴敷等非药物治疗；5天内，使用过短效抗组胺药物治疗；3天内，使用过血管收缩剂，镇静剂治疗；或因合并疾病计划在研究期间使用上述药物或治疗；（7）肾功能Scr大于参考值上限或肝功能ALT/AST>2.0倍参考值上限；（8）在试验研究期间，受试者需合并用药，且该药长期使用会影响对研究产品有效性的评估（具体由研究者评估），如：三环类抗抑郁药等药物；（9）在筛选访视（SV/V1）前21天，接种水痘/麻疹疫苗，或感染水痘/麻疹病史；（10）对试验用药品成分有过敏史；（11）皮肤试验过敏反应和/或其他严重局部反应史；（12）有长期酗酒、药物滥用史；（13）包括但不限于，合并严重心、脑、肝、肾、呼吸系统、循环系统、内分泌系统、免疫系统、造血系统等主要器官或系统的严重疾病（如急性心肌梗死、恶性肿瘤、肺结核、重症高血压、糖尿病、HIV等免疫缺陷疾病、类风湿关节炎、系统性红斑狼疮等自身免疫性疾病、白血病等）；（14）鼻腔大面积创伤；（15）在筛选访视（SV/V1）前3个月内，参加过其他药物或者医疗器械临床试验；或将在本次试验研究期间参加其他临床药物或医疗器械试验；（16）在筛选访视（SV/V1）前14天内，有活动性肺部疾病或感染（包括但不限于支气管炎、肺炎或流感）、上呼吸道或鼻窦感染，或筛选期内出现上下呼吸道感染、急性鼻窦炎；（17）在筛选访视（SV/V1）前30天内，局部使用浓度超过1%氢化可的松或等效物；使用覆盖超过20%体表的任何浓度的氢化可的松或等效物，或存在本次试验研究期间预计需要使用此类制剂治疗潜在疾病的受试者（由研究人员评估）；（18）临床研究人员/或其直系亲属；（19）有智力障碍或精神障碍；（20）研究者认为不适宜参加本临床试验，根据研究者判定，受试者因身体、文化水平或工作环境经常变动（试验期间有外地出差或旅居需要）等原因，而可能对方案任何方面（包括访视计划和日记卡或问卷的完成）的依从性产生影响。

Exclusion criteria：

Subjects who meet any of the following criteria will be excluded:(1) Pregnant or breastfeeding women, or those who do not wish to use effective contraception during the trial; (2) Comorbid vasomotor rhinitis, drug-induced rhinitis, acute rhinosinusitis, hormonal rhinitis, etc.; (3) Comorbid bronchial asthma, cough-variant asthma, and other types of asthma; (4) Comorbid organic nasal lesions, such as severe deviated septum, chronic rhinosinusitis, nasal polyps, and hypertrophic rhinitis, as evaluated by the investigator at the screening visit (SV/V1) as assessed by the investigator; (5) within 180 days of last treatment with allergen immunization, or within 6 months of nasal surgery, or within 4 weeks of major surgery (as assessed by the investigator) prior to the screening visit (SV/V1); (6) use of sublingual immunization within 180 days prior to the screening visit; and within 120 days of use of an IgE antagonist or any anti-IgE therapy, anti-interleukin-5 therapy; systemic corticosteroid therapy, immunotherapy injections, and immunosuppressive/immunomodulatory medications within 60 days; all intranasal/topical/ocular corticosteroids, inhaled corticosteroids, other investigational abiotic drugs, any known potent CYP3A4 inducer/inhibitor for treatment within 30 days; Within 14 days, treatment with all forms of sodium cromoglycate, nedocromil sodium, lodoxamide, systemic antibiotics, mast cell membrane stabilizers, monoamine oxidase inhibitors, tricyclic antidepressants; within 10 days, treatment with long-acting antihistamines; within 7 days, treatment with OTC cough and cold medicines or sleep aids that contain antihistamines, topical/oral/intranasal decongestants, leukotriene antagonists or arachidonic acid 5-lipoxygenase inhibitors, inhaled/oral/nasal anticholinergics, herbal treatments, and other non-pharmacological treatments that have a therapeutic effect on AR, such as acupuncture, acupressure, etc.; short-acting antihistamines within 5 days; vasoconstrictors within 3 days; sedatives within 3 days; or use of any of the above medications or treatments during the study period due to a comorbid condition; (7) renal function Scr greater than the upper limit of the reference value or liver function ALT/AST > 2.0 times the upper limit of the reference value; (8) During the pilot study, the subject is required to take a medication in combination and the long-term use of this medication will affect the assessment of the effectiveness of the investigational product (as assessed by the investigator), e.g., medications such as tricyclic antidepressants; (9) Varicella/measles vaccine or a history of infection with chicken pox/measles, 21 days prior to screening visit (SV/V1); (10) A history of measles infection; or measles; (10) history of allergy to the components of the test drug; (11) history of allergic skin test reactions and/or other severe local reactions; (12) history of chronic alcohol and drug abuse; (13) including, but not limited to, serious diseases of the major organs or systems, such as the heart, brain, liver, kidneys, respiratory, circulatory, endocrine, immune, and hematopoietic systems, which are combined with severe heart, brain, liver, kidney, respiratory, circulatory, endocrine, immune, and hematopoietic diseases (e.g., acute myocardial infarction, malignant tumor, tuberculosis, severe hypertension, diabetes mellitus, HIV and other immunodeficiency diseases, rheumatoid arthritis, systemic lupus erythematosus and other autoimmune diseases, leukemia, etc.); (14) extensive trauma to the nasal cavity; (15) participation in other clinical trials of drugs or medical devices in the 3 months prior to the Screening Visit (SV/V1); or will be participating in other clinical drug or medical device trials; (16) active pulmonary disease or infection (including, but not limited to, bronchitis, pneumonia, or influenza), upper respiratory tract or sinus infection within 14 days prior to the Screening Visit (SV/V1), or upper and lower respiratory tract infections, or acute sinusitis during the Screening Period; (17) topical application of topical hydrocortisone or etoricortisone in a concentration of more than 1% within 30 days prior to the Screening Visit (SV/V1) hydrocortisone or equivalent; use of any concentration of hydrocortisone or equivalent covering more than 20% of the body surface, or the presence of subjects (as assessed by the investigator) who are expected to require the use of such agents for the treatment of an underlying medical condition during the study period of this trial; (18) Clinical researchers/or members of their immediate families; (19) Mental retardation or psychiatric disorders; and (20) Subjects who, in the opinion of the investigator, are unfit to participate in this clinical trial Subjects who, in the judgment of the investigator, may have an impact on adherence to any aspect of the protocol (including visit scheduling and completion of diary cards or questionnaires) due to reasons such as physical condition, literacy level, or frequent changes in work environment (out-of-town travel or residence during the trial period).

研究实施时间：

Study execute time：

从 From 2024-06-01 00:00:00至 To 2025-01-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2024-06-01 00:00:00 至 To 2024-11-30 00:00:00  

干预措施：

Interventions：

组别：

芪丹益肺通窍颗粒组

样本量：

60

Group：

Qidan Yifei Tongqiao granules

Sample size：

干预措施：

口服芪丹益肺通窍颗粒

干预措施代码：

Intervention：

Oral Qidan Yifei Tongqiao granules

Intervention code：

组别：

安慰剂组

样本量：

30

Group：

placebo-controlled group

Sample size：

干预措施：

口服安慰剂

干预措施代码：

Intervention：

oral placebo

Intervention code：

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)：

  

Country：

China 

Province：

sichuan 

City：

 

单位(医院)：

成都中医药大学附属医院 

单位级别：

三甲 

Institution
hospital：

Hospital of Chendu University of TCM

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

鼻部症状总积分

指标类型：

主要指标

Outcome：

Total Nasal Symptom Score

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

眼部症状总积分

指标类型：

次要指标

Outcome：

Total ocular symptom score

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

鼻腔体征评分

指标类型：

次要指标

Outcome：

Nasal sign scores

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

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 Syndrome Score Scale

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

匹兹堡睡眠质量量表

指标类型：

次要指标

Outcome：

Pittsburgh Sleep Quality Inventory

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

医院焦虑抑郁量表

指标类型：

次要指标

Outcome：

Hospital Anxiety Depression Scale

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：

鼻分泌物

组织：

Sample Name：

nasal secretion

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：

鼻黏膜组织

组织：

Sample Name：

nasal mucous membrane tissue

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 65 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）：

统计人员采用 SAS 9.4版本软件，按试验组与对照组2：1比例，采用区组(block=6)随机化方法产生随机编码表。筛选期合格后评估仍合格的受试者，研究者按照先后顺序分配随机号。

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

The statistician used SAS version 9.4 software to generate a random coding table using block group (block=6) randomization in a 2:1 ratio of test group to control group. Subjects who remained qualified in the assessment after passing the screening period were assigned a randomization number by the researcher in order of precedence.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

双盲（受试者及主要研究者及其研究团队设盲）

Blinding：

Double-blind (subjects and principal investigators and their research teams are blinded)

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

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）：

公开原始数据日期：2025年7月31日。方式：向研究者联系索取

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

Publicly available raw data date: July 31, 2025 Means: Contact the researcher for a copy

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：

病历记录表（CRF）表，epidata软件3.1版

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

Chart Record Form (CRF) form, epidata software version 3.1

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2024-05-30 16:38:12