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Intranasal Acupuncture for Allergic rhinitis(INACCR): A Double-Blind RCT Comparing Active Treatment to Novel Sham Device

注册号：

Registration number：

ITMCTR2025000773

最近更新日期：

Date of Last Refreshed on：

2025-04-17

注册时间：

Date of Registration：

2025-04-17

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

鼻内针治疗变应性鼻炎的随机对照研究：基于新型假针刺对照的盲法设计与疗效评估项目

Public title：

Intranasal Acupuncture for Allergic rhinitis(INACCR): A Double-Blind RCT Comparing Active Treatment to Novel Sham Device

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于解剖邻近假针刺的蝶腭神经节联合鼻内针刺治疗变应性鼻炎的单中心随机对照研究

Scientific title：

Sphenopalatine Ganglion Stimulation Combined with Intranasal Acupuncture versus Anatomical Sham Acupuncture for Allergic Rhinitis in a Single-Center Randomized Controlled Trial

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：

申请注册联系人：

柏杉

研究负责人：

柏杉

Applicant：

baishan

Study leader：

baishan

申请注册联系人电话：

Applicant telephone：

15046001029

研究负责人电话：

Study leader's telephone：

15046001029

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：

baishan@hljucm.edu.cn

研究负责人电子邮件：

Study leader's E-mail：

baishan@hljucm.edu.cn

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：

黑龙江省哈尔滨市南岗区果戈里大街411号耳鼻喉科

研究负责人通讯地址：

黑龙江省哈尔滨市南岗区果戈里大街411号耳鼻喉科

Applicant address：

Department of Otolaryngology, No. 411, Guogeli Street, Nangang District, Harbin City, Heilongjiang Province

Study leader's address：

Department of Otolaryngology, No. 411, Guogeli Street, Nangang District, Harbin City, Heilongjiang Province

申请注册联系人邮政编码：

Applicant postcode：

150001

研究负责人邮政编码：

Study leader's postcode：

150001

申请人所在单位：

黑龙江中医药大学附属第二医院

Applicant's institution：

The Second Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine

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：

中医大二院伦[2025]K34号

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：

黑龙江中医药大学附属第二医院伦理委员会

Name of the ethic committee：

Ethics Committee of the Second Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

2025/3/20 0:00:00

伦理委员会联系人：

林春盛

Contact Name of the ethic committee：

LinChunShen

伦理委员会联系地址：

黑龙江省哈尔滨市南岗区果戈里大街411号

Contact Address of the ethic committee：

No. 411 Guogeli Street Nangang District Harbin City Heilongjiang Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

0451-53628834

伦理委员会联系人邮箱：

Contact email of the ethic committee：

1229932988@qq.com

研究实施负责（组长）单位：

黑龙江中医药大学附属第二医院

Primary sponsor：

The Second Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine

研究实施负责（组长）单位地址：

黑龙江省哈尔滨市南岗区果戈里大街411号

Primary sponsor's address：

No. 411 Guogeli Street Nangang District Harbin City Heilongjiang 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)：

黑龙江省

市(区县)：

哈尔滨

Country：

China

Province：

HeiLongJiang Province

City：

Harbin

单位(医院)：

黑龙江中医药大学附属第二医院

具体地址：

黑龙江省哈尔滨市南岗区果戈里大街411号

Institution
hospital：

The Second Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine

Address：

No. 411 Guogeli Street Nangang District Harbin City Heilongjiang Province

经费或物资来源：

自筹

Source(s) of funding：

Self-funded

研究疾病：

变应性鼻炎

研究疾病代码：

Target disease：

Allergic rhinitis

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：

验证鼻内针治疗肺脾气虚型变应性鼻炎（AR）的核心疗效，并评估基于解剖邻近假穴位的盲法设计可行性

Objectives of Study：

To verify the core efficacy of intranasal acupuncture in the treatment of allergic rhinitis (AR) with lung and spleen qi deficiency and to evaluate the feasibility of blinded design based on anatomical adjacent sham acupoints

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）符合西医诊断标准 参照《中国变应性鼻炎诊断和治疗指南(2022年, 修订版)》[7]中相关标准。需满足以下条件：① 阵发性喷嚏、清水样涕、鼻痒、鼻塞≥2项，每日持续≥1小时；② 鼻黏膜苍白水肿；③ 变应原皮肤点刺试验（SPT）或血清特异性IgE阳性。"临床症状表现为鼻塞、鼻痒、喷嚏、清涕量多(以上症状出现两项或者以上),伴有眼睛干涩、眼睛发痒和咽痒。体征为鼻腔有水样分泌物,可出现鼻翼肿胀或眼睑肿胀,鼻黏膜苍白、水肿或少量充血。实验室检查为变应原皮肤点刺试验(skin prick test, SPT)呈阳性反应指征出现1种及以上者。 （2）符合中医诊断标准 中医辨证分型参照《中医耳鼻咽喉科常见病诊疗指南》[8]鼻鼽中肺脾气虚型的相关标准。表现为喷嚏、鼻塞、流大量清涕,伴随气短、脸色白、恶风寒,发作时可见眼痒或耳痒;舌质淡苔薄白,脉弱。 （3）年龄18～65岁,性别不限; （4）鼻部症状积分(total nasal symptom score, TNSS)≥4分; （5）患者自愿参与并签署知情同意书。(用清单的方式列出拟参加入选合格受试者的标准，包括疾病的诊断标准(尽可能能有定量检验指标的上、下限)；入选前受试者的相关病史、病程和治疗情况要求；其他相关标准，如年龄、性别等。)

Inclusion criteria

(1) Meet the diagnostic standards of Western medicine Refer to the relevant standards in the Guidelines for the Diagnosis and Treatment of Allergic Rhinitis in China (2022 Revised Edition) [7]. The following conditions must be met: (1) paroxysmal sneezing watery discharge nasal itching nasal congestion≥ 2 items lasting ≥ 1 hour per day; (2) pallor edema of the nasal mucosa; (3) Allergen skin prick test (SPT) or serum specific IgE positive. "The clinical symptoms are nasal congestion nasal itching sneezing and excessive discharge (two or more of the above symptoms) accompanied by dry eyes itchy eyes and itchy throat. Signs include watery discharge from the nasal cavity swelling of the alar or eyelids and pallor edema or a little hyperemia of the nasal mucosa. Those with a positive allergen skin prick test (SPT) in laboratory tests and one or more indications. (2) Meet the diagnostic standards of traditional Chinese medicine The syndrome differentiation and classification of TCM refer to the relevant standards of the "Guidelines for the Diagnosis and Treatment of Common Diseases in the Department of Otolaryngology of Traditional Chinese Medicine" [8] which is the type of lung and spleen qi deficiency in rhinorhinitis. Manifested as sneezing nasal congestion and a large runny nose accompanied by shortness of breath pale complexion and chills itchy eyes or ears can be seen during attacks; The tongue is pale and white and the pulse is weak. (3) Age 18~65 years old gender is not limited; (4) total nasal symptom score (TNSS) ≥ 4 points; (5) The patient voluntarily participates and signs the informed consent form. (List the criteria for eligible subjects to be included in the list including the diagnostic criteria for diseases (as far as possible there can be upper and lower limits of quantitative test indicators); Relevant medical history course of illness and treatment requirements of pre-enrollment subjects; Other relevant criteria such as age gender etc. )

排除标准：

（1）患有严重及危重的全身性疾病及精神疾病者； （2）近期曾行各类鼻腔手术或颅面及鼻内具有解剖学结构异常者； （3）近2周有其他呼吸系统疾病者； （4）具有出血倾向或凝血功能障碍者； （5）正在接受其他治疗或临床试验者； （6）对针灸针过敏、畏惧针刺治疗、精神高度紧张或易晕针者； （7）不能理解或配合完成评估量表者，不提供真实信息者。

Exclusion criteria：

1) Patients with severe and critical systemic diseases and mental diseases; (2) Those who have recently undergone various nasal surgeries or have anatomical structural abnormalities in the craniofacial and intranasal cavities; (3) Those with other respiratory diseases in the past 2 weeks; (4) Those with bleeding tendency or coagulation dysfunction; (5) Those who are undergoing other treatments or clinical trials; (6) Those who are allergic to acupuncture needles afraid of acupuncture treatment highly stressed or prone to fainting; (7) Those who cannot understand or cooperate with the completion of the assessment scale and do not provide true information.

研究实施时间：

Study execute time：

从From 2025-03-20

至To      2025-12-31

征募观察对象时间：

Recruiting time：

从From 2025-04-20

至To      2025-12-31

干预措施：

Interventions：

组别：

鼻内针组

样本量：

38

Group：

Intranasal Acupuncture Group

Sample size：

干预措施：

双侧内迎香、鼻丘穴各直刺1-2cm，得气后留针30min

干预措施代码：

Intervention：

Insert needles directly for 1-2 cm at each of the bilateral Neitingxiang(LI-20)and Biqiu acupoints.After obtaining the Qi sensation,retain the needles for 30 minutes

Intervention code：

组别：

假针刺组

样本量：

38

Group：

Shame Acupuncture Group

Sample size：

干预措施：

非穴位（双侧内迎香、鼻丘穴的中点处）直刺1-2cm，得气后留针30min

干预措施代码：

Intervention：

Needle insertion directly for 1-2 cm at the midpoint of the bilateral Neitingxiang and Biqiu acupoints.After obtaining the Qi sensation,retain the needles for 30 minutes

Intervention code：

样本总量 Total sample size ： 76

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

黑龙江省

市(区县)：

哈尔滨市

Country：

CHINA

Province：

HEILONGJIANG PROVINCE

City：

HARBIN

单位(医院)：

黑龙江中医药大学附属第二医院

单位级别：

三级甲等

Institution/hospital：

The Second Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine

Level of the institution：

Class 3A

测量指标：

Outcomes：

指标中文名：

症状视觉模拟量表

指标类型：

次要指标

Outcome：

VAS

Type：

Secondary indicator

测量时间点：

基线（T0）、治疗4周（T1）、治疗后2周（T2），治疗后4周（T3）

测量方法：

采用直观类比标尺法评估患者过去7d内最严重时主观鼻部不适程度0分代表无不适，10分代表严重不适，中间的刻度为不同程度鼻部不适感。分别于治疗前、末次治疗后及疗程结束后4周进行评估。VAS评分分值0~10分,分值越高症状越严重。

Measure time point of outcome：

Baseline(T0),after 4 weeks of treatment(T1),2 weeks after treatment(T2),and 4 weeks after treatment(T3).

Measure method：

Use the Visual Analogue Scale (VAS) to assess patients' worst nasal discomfort in the past 7 days (0 = no discomfort, 10 = severe discomfort). Evaluate before treatment, after the last treatment, and 4 weeks after treatment. VAS scores range from 0 - 10, higher scores mean worse symptoms.

指标中文名：

鼻症状总分

指标类型：

主要指标

Outcome：

TNSS

Type：

Primary indicator

测量时间点：

基线（T0）、治疗4周（T1）、治疗后2周（T2），治疗后4周（T3）。

测量方法：

TNSS评分包括鼻塞、鼻痒、流涕和喷嚏4个症状,根据症状轻重程度进行评分:无症状,0分;轻微,1分;中度,2分;较重,3分;非常重,4分。TNSS总分为4个症状评分之和。

Measure time point of outcome：

Baseline(T0),after 4 weeks of treatment(T1),2 weeks after treatment(T2),and 4 weeks after treatment(T3).

Measure method：

The TNSS score includes four symptoms:nasal congestion,nasal itching,rhinorrhea,and sneezing.The severity of each symptom is scored as follows:no symptoms,0 points;mild,1 point;moderate,2 points;severe,3 points;and very severe,4 points.The total TNSS score is the sum of the scores for the four symptoms.

指标中文名：

盲法成功率量表

指标类型：

次要指标

Outcome：

Likert

Type：

Secondary indicator

测量时间点：

基线（T0）、治疗4周（T1）、治疗后2周（T2），治疗后4周（T3）。

测量方法：

评分标准： 盲法有效性：计算“肯定真”+“可能真”与“肯定假”+“可能假”的正确率，成功标准为≤50%（与随机概率无统计学差异）。 症状改善：正向选项（显著改善/略有改善）计为有效，反向选项（加重）计为无效。

Measure time point of outcome：

Baseline(T0),after 4 weeks of treatment(T1),2 weeks after treatment(T2),and 4 weeks after treatment(T3).

Measure method：

Scoring Criteria: • Blinding Effectiveness:Calculate the accuracy rate of"Definitely True"+"Probably True"versus"Definitely False"+"Probably False."The success criterion is≤50%(no statistically significant difference from random probability). • Symptom Improvement:Positive options(Significant Improvement/Minor Improvement)are considered effective,while negative options(Worsening)are considered ineffective.

指标中文名：

生活质量量表

指标类型：

次要指标

Outcome：

RQLQ

Type：

Secondary indicator

测量时间点：

基线（T0）、治疗4周（T1）、治疗后3个月（T2）。

测量方法：

RQLQ评分包括28个条目,7个领域。评分越低,生活质量越好。

Measure time point of outcome：

Baseline(T0),after 4 weeks of treatment(T1),2 weeks after treatment(T2),and 4 weeks after treatment(T3).

Measure method：

The RQLQ score includes 28 items across 7 domains.The lower the score,the better the quality of life.

指标中文名：

伴随症状总分量表

指标类型：

次要指标

Outcome：

TNNSS

Type：

Secondary indicator

测量时间点：

基线（T0）、治疗4周（T1）、治疗后2周（T2），治疗后4周（T3）

测量方法：

TNNSS评分包括鼻涕从咽部流过、流泪、鼻或眼部瘙痒、鼻或口腔上颌疼痛和头痛5个伴随症状,根据症状有或无评分,无,0分; 有,1分。总分最高为5分。

Measure time point of outcome：

Baseline(T0),after 4 weeks of treatment(T1),2 weeks after treatment(T2),and 4 weeks after treatment(T3).

Measure method：

The TNNSS score includes five accompanying symptoms:postnasal drip,tearing,nasal or ocular itching,nasal or maxillary pain,and headache.The scoring is based on the presence or absence of symptoms:none,0 points;present,1 point.The maximum total score is 5 points.

指标中文名：

鼻炎控制评估测试(RCAT)

指标类型：

次要指标

Outcome：

Rhinitis Control Assessment Test(RCAT)

Type：

Secondary indicator

测量时间点：

基线（T0）、治疗4周（T1）、治疗后2周（T2），治疗后4周（T3）。

测量方法：

测试包含6个核心问题，涵盖过去一周内鼻塞、打喷嚏、眼睛流泪、症状对睡眠的影响、活动受限程度及症状总体控制效果，采用分级选项（如“从不”至“非常频繁”）量化症状频率和影响。附加问题进一步调查过去三个月的用药情况（包括处方药、非处方药、鼻腔喷雾剂等）、治疗满意度及具体疗法，以全面评估治疗效果。

Measure time point of outcome：

Baseline(T0)after 4 weeks of treatment(T1)2 weeks after treatment(T2)and 4 weeks after treatment(T3).

Measure method：

The test has 6 core questions on past-week nasal congestion, sneezing, tearing, sleep impact, activity limitation and symptom control. Graded options (e.g., never to very frequently) quantify symptom frequency and impact. Additional questions cover 3-month medication (useprescription drugs, over-the-counter drugs, nasal sprays, etc.), treatment satisfaction and therapies for full treatment evaluation.

指标中文名：

安全性（VAS疼痛评分）

指标类型：

次要指标

Outcome：

Safety(VAS pain score)

Type：

Secondary indicator

测量时间点：

基线（T0）、治疗4周（T1）、治疗后2周（T2），治疗后4周（T3）。

测量方法：

评分范围0-10分（0=无痛，10=难以忍受的剧痛。评估时，患者在治疗后立即于标尺上标记疼痛强度，研究者根据标记位置转换为具体分值。评分标准参考国际疼痛研究协会（IASP）指南，并结合针灸操作特点细化疼痛描述与应对措施（如轻度疼痛以观察为主，重度需紧急处理）。

Measure time point of outcome：

Baseline(T0)after 4 weeks of treatment(T1)2 weeks after treatment(T2)and 4 weeks after treatment(T3).

Measure method：

Score range: 0 - 10 (0 = no pain, 10 = unbearable severe pain). During assessment, patients mark pain intensity on the scale right after treatment, and researchers convert marks to scores. The scoring standard refers to the International Association for the Study of Pain (IASP) guidelines, and refines pain descriptions and countermeasures (e.g., observe mild pain, handle severe pain urgently) based on acupuncture characteristics.

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

不收集人体标本

Fate of sample 

Others

Note：

征募研究对象情况：

尚未开始

Not yet recruiting

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）：

专员采用R语言blockrand包生成混合区块随机序列（区块长4/6/8），总样本量76例（考虑20%脱落率）。 分配隐藏通过密封不透光信封法实现。随机序列被密封于连续编号的防篡改信封中，封面仅标注受试者ID，内页包含分组信息（A组：真针刺；B组：假针刺）及详细操作步骤。信封由独立研究协调员管理，仅在受试者完成基线评估后按顺序拆封，并立即登记分组。空信封留存备查，每10例抽查一次完整性。

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

The research officer used the R package"blockrand"to generate a permuted block randomization sequence(with block sizes of 4/6/8)with a total sample size of 76 participants(considering a 20%dropout rate). Allocation concealment was achieved through the use of sealedopaque envelopes.The randomization sequence was sealed in sequentially numbered tamper-proof envelopes.The envelope cover only indicated the participant's IDwhile the inner page contained the group assignment information(Group A:real acupuncture;Group B:sham acupuncture)and detailed procedural steps.The envelopes were managed by an independent research coordinatorwho only opened them in sequence after the participant had completed the baseline assessment and immediately recorded the group assignment.The empty envelopes were retained for audit purposeswith the integrity of every 10 envelopes being checked periodically.

盲法：

Blinding：

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)：

不共享

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）填写 CRF ，包括可能发生的不良事件及处理措施：鼻出血过多等。研究者根据受试者的住院病历、原始观察记录，及时、完整、正确、清晰地填写病例报告表。 （2）核对 CRF 监督试验是否遵循试验方案。确认所有病例报告表填写正确完整，并与原始资料一致。如有错误和遗漏，及时要求研究者更正。修改时需保持原有记 录清晰可见，改正处需经研究者签名并注明日期。 （3）收回 CRF 对于完成的病例报告表在研究者、数据管理员之间的传送，应有专门的记录，收到时应有相应的签名，记录需妥善保存。

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

(1) Completion of the CRF including possible adverse events and treatment measures: excessive nosebleed etc. The investigator completes the case report form in a timely complete correct and legible manner based on the subject's hospitalization history and original observation record. (2) Verify that the CRF surveillance trial followed the trial protocol. Confirm that all case report forms are filled out correctly and completely and are consistent with the original information. If there are errors or omissions ask the investigator to make corrections in a timely manner. Corrections should be made in such a way that the original records are legible and the corrections should be signed and dated by the investigator. (3) Retrieval of the CRF A special record should be kept of the transmission of the completed CRF between the investigator and the data manager with appropriate signatures on receipt and the record should be kept appropriately.

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）：

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

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