Tiluo Yangxue prescription and acupuncture for visual function of primary open‐angle glaucoma: A Randomized Controlled 2×2 Factorial Trial

注册号:

Registration number:

ITMCTR2025000202

最近更新日期:

Date of Last Refreshed on:

2025-01-28

注册时间:

Date of Registration:

2025-01-28

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

剔络养血方和针刺改善眼压稳定后原发性开角型青光眼视功能的疗效和安全性评价:一项随机对照,2×2析因试验研究

Public title:

Tiluo Yangxue prescription and acupuncture for visual function of primary open‐angle glaucoma: A Randomized Controlled 2×2 Factorial Trial

注册题目简写:

English Acronym:

研究课题的正式科学名称:

剔络养血方和针刺改善眼压稳定后原发性开角型青光眼视功能的疗效和安全性评价:一项随机对照,2×2析因试验研究

Scientific title:

Tiluo Yangxue prescription and acupuncture for visual function of primary open‐angle glaucoma: A Randomized Controlled 2×2 Factorial 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:

李欣

研究负责人:

李欣

Applicant:

Li Xin

Study leader:

Li Xin

申请注册联系人电话:

Applicant telephone:

13466768896

研究负责人电话:

Study leader's telephone:

13466768896

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:

doudou8295@163.com

研究负责人电子邮件:

Study leader's E-mail:

doudou8295@163.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:

北京市石景山区鲁谷路33号

研究负责人通讯地址:

北京市石景山区鲁谷路33号

Applicant address:

33 Lugu Road Shijingshan District Beijing

Study leader's address:

33 Lugu Road Shijingshan 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:

中国中医科学院眼科医院

Applicant's institution:

Eye Hospital of China Academy of CMS

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:

YKEC-KT-2024-053-P002

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:

中国中医科学院眼科医院医学伦理委员会

Name of the ethic committee:

Medical Ethics Committee of Eye Hospital of China Academy of CMS

伦理委员会批准日期:

Date of approved by ethic committee:

2024/11/19 0:00:00

伦理委员会联系人:

张晓敏

Contact Name of the ethic committee:

Zhang Xiaomin

伦理委员会联系地址:

北京市石景山区鲁谷路33号

Contact Address of the ethic committee:

33 Lugu Road Shijingshan District Beijing

伦理委员会联系人电话:

Contact phone of the ethic committee:

010-68688877-5589

伦理委员会联系人邮箱:

Contact email of the ethic committee:

ykec@163.cm

研究实施负责(组长)单位:

中国中医科学院眼科医院

Primary sponsor:

Eye Hospital of China Academy of CMS

研究实施负责(组长)单位地址:

北京市石景山区鲁谷路33号

Primary sponsor's address:

33 Lugu Road Shijingshan 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):

石景山区

Country:

China

Province:

Beijing

City:

Shijingshan District

单位(医院):

中国中医科学院眼科医院

具体地址:

北京市石景山鲁谷路33号

Institution
hospital:

Eye Hospital of China Academy of CMS

Address:

33 Lugu Road Shijingshan District Beijing

经费或物资来源:

中国中医科学院眼科医院中央高水平中医医院项目

Source(s) of funding:

Central High-Level Traditional Chinese Medicine Hospital Project of eye Hospital China Academy of Chinese medical science

研究疾病:

青光眼

研究疾病代码:

Target disease:

glaucoma

Target disease code:

研究类型:

Study type:

干预性研究

Interventional study

研究设计:

Study design:

析因分组(即根据危险因素或暴露因素分组)

Factorial

研究所处阶段:

Study phase:

治疗新技术临床试验

New Treatment Measure Clinical Study

研究目的:

客观评价剔络养血方、针刺,以及二者联合改善青光眼视功能的有效性,探讨作用机制,优化改善青光眼视功能的中医药治疗方案。

Objectives of Study:

Objective evaluation of the effectiveness of Tiaoluo Yangxue Formula acupuncture and their combined improvement of glaucoma visual function exploration of their mechanisms of action and optimization of traditional Chinese medicine treatment plans for improving glaucoma visual function.

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)经完善的眼科检查,符合POAG诊断标准; (2)中医辨证为气血亏虚、络脉幽微证; (3)18岁≤年龄≤70岁; (4)研究眼局部降眼压药物治疗1个月/选择性激光小梁成形术、抗青光眼手术后6个月/未用药情况下,10mmHg≤24小时眼压峰值≤21mmHg(Goldman眼压计测定24小时眼压曲线)。纳入前治疗方案稳定大于3周; (5)研究眼最佳矫正视力≥20/200(ETDRS视力表); (6)研究眼Humphrey视野(改良H-P-A视野分期)为早期、中期、进展期; (7)受试者纳入前正在服用改善循环、营养神经药物,或同类中药汤剂、颗粒剂、中成药者,经 4 周洗脱期,可以纳入本试验。受试者纳入前正在滴用酒石酸溴莫尼定滴眼液者,经2周洗脱期,可以纳入本试验。受试者纳入前正在接受针灸、耳穴压丸等同类型治疗者,停止2周后可以纳入本试验; (8)知情同意并签署知情同意。 注:每位受试者以单眼作为研究对象,具体以发病较重的一侧作为研究眼,双眼严重程度一致者则以右眼作为研究眼。对侧眼接受同样治疗,不纳入临床研究。

Inclusion criteria

(1) After a comprehensive ophthalmic examination it meets the diagnostic criteria for POAG; (2) Traditional Chinese medicine syndrome differentiation is characterized by deficiency of qi and blood and subtle meridians and collaterals; (3) 18 years old ≤ age ≤ 70 years old; (4) Study on the effect of topical intraocular pressure lowering medication for 1 month/6 months after selective laser trabeculoplasty and anti glaucoma surgery/without medication with a peak intraocular pressure of 10mmHg ≤ 24 hours ≤ 21mmHg (measured by Goldman tonometer 24-hour intraocular pressure curve). Stable treatment plan for more than 3 weeks before inclusion; (5) Study the best corrected visual acuity of the eyes ≥ 20/200 (ETDRS visual acuity chart); (6) Study the Humphrey visual field (modified H-P-A visual field staging) as early middle and advanced stages; (7) Subjects who were taking drugs to improve circulation and nutrition or similar traditional Chinese medicine decoction granule traditional Chinese patent medicines and simple preparations before inclusion can be included in this trial after a 4-week wash out period. Subjects who were receiving Bromonidine Tartrate eye drops before inclusion and had a 2-week washout period can be included in this trial. Subjects who were receiving acupuncture and moxibustion ear point pressing pills and the same type of treatment before inclusion can be included in this trial after 2 weeks of cessation; (8) Informed consent and signing of informed consent. Note: Each participant will be studied on one eye with the more severely affected side as the study eye. For those with the same severity in both eyes the right eye will be used as the study eye. The contralateral eye received the same treatment and was not included in the clinical study.

排除标准:

(1)研究眼合并具有临床意义的角膜、虹膜、明显晶状体病变及各种眼底病变、视神经病变,如角膜炎、葡萄膜炎、青光眼睫状体炎综合征,视网膜脱落、视网膜动静脉阻塞、视网膜色素变性、糖尿病性视网膜病变、缺血性视神经病变等; (2)有严重干眼症病史; (3)屈光间质明显混浊,经研究者判断影响视力、视野等检查者(轻度混浊,经研究者判断不影响视力、视野检查者仍可纳入试验); (4)独眼或眼部畸形者; (5)无法接受压平式眼压计测量者(如:角膜表面明显异常、角膜瘢痕、圆锥角膜等); (6)试验期间必须佩戴角膜接触镜者(如:隐形眼镜或者美瞳); (7)任何眼近3个月内任何活动性或复发性眼内感染、眼内炎症者; (8)研究眼近6个月内行任何内眼手术者; (9)研究眼近6个月内存在眼部创伤者; (10)需要使用改善循环、营养神经药物者 ,短期不能停用者; (11)计划行任何眼部的手术或激光治疗者; (12)智力、认知障碍或精神疾病不能给予充分知情同意者(轻度焦虑或抑郁患者除外); (13)筛选检查结果满足以下任意一条标准:①未经治疗或控制不佳的高血压:收缩压(SBP)≥160mmHg和/或舒张压(DBP)≥100 mmHg;②未经治疗或控制不佳的糖尿病;③未经治疗或无法控制的甲状腺功能减退症/甲状腺功能亢进症;④肝功明显异常:ALT/AST)≥1.5倍正常值上限;⑤肾功明显异常:肌酐高于正常值上限;⑤凝血功能障碍;⑥合并重度心肺功能不全、重度心律失常者(快速房颤、房扑,阵发性室速、Ⅲ度房室传导阻滞等);⑦晚期肿瘤,和或其它系统严重或进行性疾病者。 (14)正在参加其他药物临床实验者,或在3个月内曾参加过类似药物的临床试验者; (15)妊娠试验阳性、妊娠期或哺乳期妇女、计划妊娠者; (16)怀疑或确有酒精、药物滥用史者; (17)对3种及以上药物或食物过敏者,或已知对中药颗粒剂及其成分过敏者; (18)研究者认为不适宜参加本临床试验者;

Exclusion criteria:

(1) To study the clinical significance of cornea iris obvious lens diseases and various fundus diseases optic neuropathy in the eyes such as keratitis uveitis glaucoma and ciliary syndrome retinal detachment retinal arteriovenous occlusion retinitis pigmentosa diabetes retinopathy ischemic optic neuropathy etc; (2) History of severe dry eye syndrome; (3) The refractive interstitium is significantly turbid which is judged by the researchers to affect vision visual field and other examinations (mild turbidity which is judged by the researchers to not affect vision visual field and other examinations can still be included in the experiment); (4) Individuals with one eye or eye deformities; (5) Those who cannot accept the use of a flat tonometer for measurement (such as obvious abnormalities on the corneal surface corneal scars keratoconus etc.); (6) Those who must wear contact lenses (such as contact lenses or contact lenses) during the trial period; (7) Any active or recurrent intraocular infection or inflammation in any eye within the past 3 months; (8) Study individuals who have undergone any intraocular surgery within the past 6 months; (9) Study individuals who have experienced eye trauma within the past 6 months; (10) Those who need to use drugs that improve circulation and nourish nerves and those who cannot stop using them in the short term; (11) Those who plan to undergo any eye surgery or laser treatment; (12) Individuals with intellectual or cognitive impairments or mental illnesses who are unable to provide sufficient informed consent (excluding those with mild anxiety or depression); (13) The screening test results meet any of the following criteria: ① Untreated or poorly controlled hypertension: systolic blood pressure (SBP) ≥ 160mmHg and/or diastolic blood pressure (DBP) ≥ 100 mmHg; ② Untreated or poorly controlled diabetes; ③ Untreated or uncontrolled hypothyroidism/hyperthyroidism; ④ Significant abnormal liver function: ALT/AST ≥ 1.5 times the upper limit of normal value; ⑤ Significant abnormalities in renal function: creatinine above the upper limit of normal; ⑤ Coagulation dysfunction; ⑥ Patients with severe heart and lung dysfunction severe arrhythmia (rapid atrial fibrillation atrial flutter paroxysmal ventricular tachycardia third degree atrioventricular block etc.); ⑦ Patients with advanced tumors or other severe or progressive systemic diseases. (14) Those who are currently participating in clinical trials of other drugs or have participated in clinical trials of similar drugs within the past 3 months; (15) Positive pregnancy test pregnant or lactating women and those planning to conceive; (16) Suspected or with a history of alcohol or drug abuse; (17) Individuals who are allergic to three or more drugs or foods or known to be allergic to traditional Chinese medicine granules and their components; (18) Researchers believe that individuals who are not suitable to participate in this clinical trial;

研究实施时间:

Study execute time:

From 2024-04-01

To      2026-09-30

征募观察对象时间:

Recruiting time:

From 2025-02-15

To      2026-06-30

干预措施:

Interventions:

组别:

中药颗粒剂+针刺组

样本量:

77

Group:

Chinese herbal granules+acupuncture group

Sample size:

干预措施:

剔络养血颗粒剂冲服,针刺治疗

干预措施代码:

A1B1

Intervention:

Tiluo Yangxue Granules for oral administration,acupuncture treatmentt

Intervention code:

组别:

中药模拟颗粒剂+针刺等待组

样本量:

77

Group:

Chinese herbal simulated granules+acupuncture waiting group

Sample size:

干预措施:

剔络养血模拟颗粒剂,针刺等待

干预措施代码:

A0B0

Intervention:

Tiluo Yangxue simulated Granules for oral administration,acupuncture treatment later

Intervention code:

组别:

中药模拟颗粒剂+针刺组

样本量:

77

Group:

Chinese herbal simulated granules+acupuncture Group

Sample size:

干预措施:

剔络养血模拟颗粒剂,针刺治疗

干预措施代码:

A0B1

Intervention:

Tiluo Yangxue simulated Granules for oral administration,acupuncture treatment

Intervention code:

组别:

中药颗粒剂+针刺等待组

样本量:

77

Group:

Chinese herbal granules+acupuncture waiting group

Sample size:

干预措施:

剔络养血颗粒剂冲服,针刺等待

干预措施代码:

A1B0

Intervention:

Tiluo Yangxue Granules for oral administration,acupuncture treatment later

Intervention code:

样本总量 Total sample size : 308

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):

石景山

Country:

China

Province:

Beijing

City:

单位(医院):

中国中医科学院眼科医院

单位级别:

三级甲等专科医院

Institution/hospital:

Eye Hospital of China Academy of CMS

Level of the institution:

Grade III Grade A specialized hospital

国家:

中国

省(直辖市):

北京

市(区县):

海淀区

Country:

China

Province:

Beijing

City:

Haidian District

单位(医院):

中国中医科学院西苑医院

单位级别:

三级甲等综合医院

Institution/hospital:

Xiyuan Hospital Chinese Academy of Traditional Chinese Medicine

Level of the institution:

Grade III Grade A Comprehensive Hospital

国家:

中国

省(直辖市):

北京

市(区县):

丰台区

Country:

China

Province:

Beijing

City:

Fengtai District

单位(医院):

北京中医药大学东方医院

单位级别:

三级甲等综合医院

Institution/hospital:

Dongfang Hospital of Beijing University of Traditional Chinese Medicine

Level of the institution:

Grade III Grade A Comprehensive Hospital

测量指标:

Outcomes:

指标中文名:

治疗4周末视网膜电图明视负波反应(PhNR)振幅较基线的变化

指标类型:

附加指标

Outcome:

The changes in amplitude of photopic negative wave response (PhNR) in electroretinogram after 4 weeks of treatment compared to baseline

Type:

Additional indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

治疗2周末视野平均缺损(MD)较基线的变化

指标类型:

次要指标

Outcome:

The change in mean defect (MD) of visual field from baseline at 2 weeks 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2周末、治疗4周末中医证候量化表评分较基线的变化

指标类型:

次要指标

Outcome:

The Changes in Traditional Chinese Medicine Syndrome Quantification Scale Scores from Baseline at Weekends 2 and 4 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:

治疗结束后第4周末视野模式标准差(PSD)较基线的变化

指标类型:

附加指标

Outcome:

The Changes in standard deviation of visual field pattern (PSD) compared to baseline at the end of the fourth week after treatment

Type:

Additional indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

治疗结束后第4周末青光眼患者生活质量量表(Glau-QoL17)评分较基线的变化

指标类型:

附加指标

Outcome:

The changes in Glau-QoL17 scores of glaucoma patients compared to baseline at the end of the fourth week after treatment

Type:

Additional indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

治疗结束后第4周末视野平均缺损(MD)较基线的变化

指标类型:

附加指标

Outcome:

The Changes in mean visual field defect (MD) compared to baseline at the end of the fourth week after treatment

Type:

Additional indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

治疗结束后第4周末最佳矫正视力(BCVA)较基线的变化

指标类型:

附加指标

Outcome:

The changes in best corrected visual acuity (BCVA) compared to baseline at the end of the fourth week after treatment

Type:

Additional indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

治疗结束后第4周末中医证候量化表评分较基线的变化

指标类型:

附加指标

Outcome:

The changes in Traditional Chinese Medicine Syndrome Quantification Scale Score Compared to Baseline at the Fourth Weekend After Treatment

Type:

Additional indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

治疗2周末、治疗4周末最佳矫正视力(BCVA)较基线的变化

指标类型:

次要指标

Outcome:

The changes in best corrected visual acuity (BCVA) compared to baseline during the 2nd and 4th weekend 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4周末视野平均缺损(MD)较基线的变化

指标类型:

主要指标

Outcome:

The change in mean defect (MD) of visual field from baseline the end of 4 weeks of treatment

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2周末、治疗4周末视野模式标准差(PSD)较基线的变化

指标类型:

次要指标

Outcome:

The changes in the pattern standard deviation (PSD) of the visual field at 2 and 4 weeks of treatment compared with the baseline

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2周末、治疗4周末青光眼患者生活质量量表(Glau-QoL17)评分较基线的变化

指标类型:

次要指标

Outcome:

The Changes in Quality of Life Scale (Glau-QoL17) scores of glaucoma patients after 2 and 4 weeks of treatment compared to baseline

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4周末视盘血流密度较基线的变化

指标类型:

附加指标

Outcome:

The changes in optic disc blood flow density compared to baseline after 4 weeks of treatment

Type:

Additional 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:

征募研究对象情况:

尚未开始

Not yet recruiting

年龄范围:

最小 18
Min age years
最大 70
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):

本项目应用中国中医科学院中医药数据中心中央随机系统,使用SAS 9.2版生成随机化方案,按1:1:1:1的比例随机分为4组: 中药颗粒剂+针刺组、中药颗粒剂+针刺等待组、中药模拟颗粒剂+针刺组,中药模拟颗粒剂+针刺等待组,将每组随机代码按照中心分层,区组随机的方式,配置到中央随机系统中。

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

This project will apply the central randomization system of the Traditional Chinese Medicine Data Center of the Chinese Academy of Traditional Chinese Medicine. SAS version 9.2 is used to generate a randomization scheme which is randomly divided into four groups in a 1:1:1:1 ratio: Chinese herbal granules+acupuncture group Chinese herbal granules+acupuncture waiting group Chinese herbal simulated granules+acupuncture group Chinese herbal simulated granules+acupuncture waiting group. The random codes of each group are configured into the central randomization system according to the central stratification and block randomization method.

盲法:

Blinding:

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):

研究完成后会以文章发表的方式共享数据,部分原始数据可通过邮箱与通讯作者联系获得

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

After the research is completed, the data will be shared in the form of an article, and some of the raw data can be obtained by contacting the corresponding author via email

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:

填写CRF表,应用中国中医科学院中医药数据EDC系统进行数据管理

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

Fill out the CRF form and use the Traditional Chinese Medicine Data EDC system of the Chinese Academy of Traditional Chinese Medicine for data management

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):

ITMCTR BJ-ICP:07032215-5 Tip: IE8 is recommended Use the system with widescreen display resolution above