我要注册
立即登录
中文/English
平台介绍|试验检索|关于我们|新闻公告
A Randomised Pilot Trial Evaluating a Chinese Medicine Formula in the Treatment of Chronic Subjective Tinnitus

注册号：

Registration number：

ITMCTR2200005486

最近更新日期：

Date of Last Refreshed on：

2021-05-23

注册时间：

Date of Registration：

2021-05-23

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

A Randomised Pilot Trial Evaluating a Chinese Medicine Formula in the Treatment of Chronic Subjective Tinnitus

Public title：

A Randomised Pilot Trial Evaluating a Chinese Medicine Formula in the Treatment of Chronic Subjective Tinnitus

注册题目简写：

Chinese medicine for tinnitus

English Acronym：

Chinese medicine for tinnitus

研究课题的正式科学名称：

A Randomised Pilot Trial Evaluating a Chinese Medicine Formula in the Treatment of Chronic Subjective Tinnitus

Scientific title：

A Randomised Pilot Trial Evaluating a Chinese Medicine Formula in the Treatment of Chronic Subjective Tinnitus

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：

ChiCTR2100046632 ; ChiMCTR2200005486

申请注册联系人：

Zhang, Hongwei

研究负责人：

Zhang, Hongwei

Applicant：

Zhang, Hongwei

Study leader：

Zhang, Hongwei

申请注册联系人电话：

Applicant telephone：

+852-39439845

研究负责人电话：

Study leader's telephone：

+852-39439845

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：

zhanghw@cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

zhanghw@cuhk.edu.hk

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：

中國香港特別行政區新界沙田香港中文大學崇基學院信和樓一樓

研究负责人通讯地址：

中國香港特別行政區新界沙田香港中文大學崇基學院信和樓一樓

Applicant address：

1st floor, Sino Building, Chung Chi College, The Chinese University of Hong Kong, Shatin, N.T. Hong Kong, China

Study leader's address：

1st floor, Sino Building, Chung Chi College, The Chinese University of Hong Kong, Shatin, N.T. Hong Kong, China

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：

香港中文大學

Applicant's institution：

The Chinese University of Hong Kong

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：

2019.670

伦理委员会批件附件：

Approved file of Ethical Committee：

批准本研究的伦理委员会名称：

香港中文大學-新界東醫院聯網臨床研究倫理聯席委員會

Name of the ethic committee：

The Joint Chinese University of Hong Kong – New Territories East Cluster Clinical Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

1990/1/1 0:00:00

伦理委员会联系人：

Envy Lee

Contact Name of the ethic committee：

Envy Lee

伦理委员会联系地址：

中國香港特別行政區新界沙田銀城街威爾士親王醫院呂志和臨床醫學大樓八樓

Contact Address of the ethic committee：

8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, N.T., Hong Kong, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

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：

School of Chinese Medicine, the Chinese University of Hong Kong

Primary sponsor：

School of Chinese Medicine, the Chinese University of Hong Kong

研究实施负责（组长）单位地址：

中國香港特別行政區新界沙田香港中文大學崇基學院信和樓一樓

Primary sponsor's address：

1st floor, Sino-building, School of Chinese Medicine, the Chinese University of Hong Kong, N.T. Hong Kong, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中國

省(直辖市)：

香港特別行政區

市(区县)：

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

香港中文大學

具体地址：

新界沙田香港中文大學崇基學院信和樓

Institution
hospital：

Chinese University of Hong Kong

Address：

1st floor, Sino-building, School of Chinese Medicine, the Chinese University of Hong Kong, N.T.

经费或物资来源：

Hong Kong Health and Medical Research Fund

Source(s) of funding：

Hong Kong Health and Medical Research Fund

研究疾病：

Chronic Subjective Tinnitus

研究疾病代码：

Target disease：

Chronic Subjective Tinnitus

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：

To determine the feasibility of performing a full-scale RCT for evaluating the effectiveness and safety of BHT for patients with chronic subjective tinnitus; To explore whether a TCM formula (BHT) has additional effect on improving the impact of tinnitus in daily life and psychological function and also the perception of tinnitus after 8-week treatment and 4-week follow-up when compared to informative counselling alone.

Objectives of Study：

To determine the feasibility of performing a full-scale RCT for evaluating the effectiveness and safety of BHT for patients with chronic subjective tinnitus; To explore whether a TCM formula (BHT) has additional effect on improving the impact of tinnitus in daily life and psychological function and also the perception of tinnitus after 8-week treatment and 4-week follow-up when compared to informative counselling alone.

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) Diagnosis of unilateral or bilateral subjective continuous (24 hours) tinnitus with normal hearing or bilateral / unilateral mild to moderate hearing loss. i.e. an average pure-tone audiometry threshold for 500, 1000 and 2000 Hz between 0 dB HL and 55 dB HL; 2) Aged between 18 and 50 years old; 3) Tinnitus duration of at least 6 months; 4) Moderate level of distress caused by tinnitus with scores above 38 on the Chinese (Cantonese) version of the Tinnitus Handicap Inventory (THI-CH) [25-26]; 5) Having symptoms of low back pain or general fatigue, and dark or pale tongue, which are symptoms or signs of TCM syndrome of kidney essence deficiency and stagnation of Qi and blood flowing in the meridian.

Inclusion criteria

1) Diagnosis of unilateral or bilateral subjective continuous (24 hours) tinnitus with normal hearing or bilateral / unilateral mild to moderate hearing loss. i.e. an average pure-tone audiometry threshold for 500, 1000 and 2000 Hz between 0 dB HL and 55 dB HL; 2) Aged between 18 and 50 years old; 3) Tinnitus duration of at least 6 months; 4) Moderate level of distress caused by tinnitus with scores above 38 on the Chinese (Cantonese) version of the Tinnitus Handicap Inventory (THI-CH) [25-26]; 5) Having symptoms of low back pain or general fatigue, and dark or pale tongue, which are symptoms or signs of TCM syndrome of kidney essence deficiency and stagnation of Qi and blood flowing in the meridian.

排除标准：

1) Has predisposing disease with tinnitus symptoms amenable to medical or surgical intervention; 2) Has diagnosis of pulsatile tinnitus, somatosounds, or objective tinnitus; 3) Has emotional, psychological, or psychiatric condition precluding full participation of the study; 4) Has ever received any clinical treatment for tinnitus within previous one month; 5) being pregnant, preparing for pregnancy or breast-feeding; 6) has ever taken any Chinese herbal medicine treatment in the previous one month; 7) has history of being allergy to Chinese herbal medicines; 8) Has ever taken any anti-coagulant or anti-platelet agents other than low dose (≤81 mg per day) aspirin; 9) Has sever diabetes, hypertension or cardiac, liver, renal, cerebrovascular disease, or malignant diseases.

Exclusion criteria：

1) Has predisposing disease with tinnitus symptoms amenable to medical or surgical intervention; 2) Has diagnosis of pulsatile tinnitus, somatosounds, or objective tinnitus; 3) Has emotional, psychological, or psychiatric condition precluding full participation of the study; 4) Has ever received any clinical treatment for tinnitus within previous one month; 5) being pregnant, preparing for pregnancy or breast-feeding; 6) has ever taken any Chinese herbal medicine treatment in the previous one month; 7) has history of being allergy to Chinese herbal medicines; 8) Has ever taken any anti-coagulant or anti-platelet agents other than low dose (≤81 mg per day) aspirin; 9) Has sever diabetes, hypertension or cardiac, liver, renal, cerebrovascular disease, or malignant diseases.

研究实施时间：

Study execute time：

从From 2020-09-01

至To      2022-04-30

征募观察对象时间：

Recruiting time：

从From 2021-06-01

至To      2022-03-31

干预措施：

Interventions：

组别：

Experimental group

样本量：

12

Group：

Experimental group

Sample size：

干预措施：

Chinese medicine formula plus informative counselling

干预措施代码：

Intervention：

Chinese medicine formula plus informative counselling

Intervention code：

组别：

Control group

样本量：

12

Group：

Control group

Sample size：

干预措施：

Informative counselling

干预措施代码：

Intervention：

Informative counselling

Intervention code：

样本总量 Total sample size ： 24

研究实施地点：

Countries of recruitment
and research settings：

国家：

中國

省(直辖市)：

香港特別行政區

市(区县)：

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

CUHK

单位级别：

Tertiary Hospital

Institution/hospital：

CUHK

Level of the institution：

Tertiary Hospital

测量指标：

Outcomes：

指标中文名：

feasibility of a full-scale RCT

指标类型：

主要指标

Outcome：

feasibility of a full-scale RCT

Type：

Primary 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：

组织：

Sample Name：

None

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：

正在进行

Recruiting

年龄范围：

最小 18 岁
Min age years
最大 50 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）：

A computer-generated random allocation sequence through the block randomization method will be used. A research staff, with no clinical involvement in the trial, will be responsible for keeping the random allocation list and preparing sealed, opaque sequentially numbered envelopes, each containing a random number denoting&

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

A computer-generated random allocation sequence through the block randomization method will be used.

盲法：

Not stated

Blinding：

Not stated

是否共享原始数据：

IPD sharing：

是

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）：

Publish in academic journal

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

Publish in academic journal

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：

Case report forms (CRFs) will be developed for recording the individual patient data. The investigators will assure all reported trial data are accurate, complete and verifiable from source documents.All adverse events during the study will be monitored and recorded on the Adverse Event Page of the CRF. The study committee will hold regular conference to monitor the patients’ safety and the integrity of the data with respect to the original study design, and to provide advice on study conduct.

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

Case report forms (CRFs) will be developed for recording the individual patient data. The investigators will assure all reported trial data are accurate, complete and verifiable from source documents.All adverse events during the study will be monitored and recorded on the Adverse Event Page of the CRF. The study committee will hold regular conference to monitor the patients’ safety and the integrity of the data with respect to the original study design, and to provide advice on study conduct.

数据管理委员会：

Data Managemen Committee：

有

Yes

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):

返回
平台信息
平台简介
关于我们
试验注册
常见问题
伦理审查
公共服务
试验检索
参与我们
国际传统医学临床试验注册平台 京ICP备07032215号-5 提示：推荐使用IE8.0以上版本 宽屏显示分辨率下使用系统