Clinical Study to Evaluate the Effect of "Postoperative thyroid Cancer Chinese medicine decoction " combined with Eugenol in the Treatment of Postoperative Differentiated Thyroid Cancer

注册号:

Registration number:

ITMCTR2025000210

最近更新日期:

Date of Last Refreshed on:

2025-02-03

注册时间:

Date of Registration:

2025-02-03

注册号状态:

Registration Status:

补注册

Retrospective registration

注册题目:

“ 甲癌术后方”联合优甲乐治疗分化型甲状腺癌术后临床研究

Public title:

Clinical Study to Evaluate the Effect of "Postoperative thyroid Cancer Chinese medicine decoction " combined with Eugenol in the Treatment of Postoperative Differentiated Thyroid Cancer

注册题目简写:

English Acronym:

研究课题的正式科学名称:

“ 甲癌术后方”联合优甲乐治疗分化型甲状腺癌术后临床研究

Scientific title:

Clinical Study to Evaluate the Effect of "Postoperative thyroid Cancer Chinese medicine decoction " combined with Eugenol in the Treatment of Postoperative Differentiated Thyroid Cancer

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:

王玥琦

研究负责人:

夏仲元

Applicant:

Wang Yueqi

Study leader:

Xia Zhongyuan

申请注册联系人电话:

Applicant telephone:

18810382867

研究负责人电话:

Study leader's telephone:

13701338757

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:

yqw3@qq.com

研究负责人电子邮件:

Study leader's E-mail:

2718421708@qq.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:

北京市朝阳区樱花园东街2号中日友好医院,

研究负责人通讯地址:

北京市朝阳区樱花园东街2号中日友好医院,

Applicant address:

No.2 Yinghuayuan East Street Chaoyang District Beijing

Study leader's address:

No.2 Yinghuayuan East Street Chaoyang 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:

中日友好医院

Applicant's institution:

China-Japan Friendship Hospital

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:

2022-KY-062

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:

中日友好医院临床研究伦理委员会

Name of the ethic committee:

Clinical Research Ethics Committee of China-Japan Friendship Hospital

伦理委员会批准日期:

Date of approved by ethic committee:

2022/6/24 0:00:00

伦理委员会联系人:

崔勇

Contact Name of the ethic committee:

Cui Yong

伦理委员会联系地址:

中日友好医院,北京市朝阳区樱花园东街2号

Contact Address of the ethic committee:

China-Japan Friendship HospitalNo.2 Yinghuayuan East Street Chaoyang District Beijing

伦理委员会联系人电话:

Contact phone of the ethic committee:

84205566

伦理委员会联系人邮箱:

Contact email of the ethic committee:

zryyzczx2021@163.com

研究实施负责(组长)单位:

中日友好医院

Primary sponsor:

China-Japan Friendship Hospital

研究实施负责(组长)单位地址:

北京市朝阳区樱花园东街2号中日友好医院,

Primary sponsor's address:

No.2 Yinghuayuan East Street Chaoyang 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):

北京

Country:

China

Province:

Beijing

City:

单位(医院):

中日友好医院

具体地址:

北京市朝阳区樱花园东街2号中日友好医院,

Institution
hospital:

China-Japan Friendship Hospital

Address:

No.2 Yinghuayuan East Street Chaoyang District Beijing

经费或物资来源:

中央高水平医院临床科研业务费资助

Source(s) of funding:

National High Level Hospital Clinical Research Funding

研究疾病:

分化型甲状腺癌

研究疾病代码:

Target disease:

Differentiated Thyroid Carcinoma

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:

其它

Others

研究目的:

本研究拟设计单中心、优效对照临床研究,以 DTC 术后患者为研究对象, 将 306 例患者随机分为对照组与治疗组,对照组给予标准化优甲乐治疗,治疗组 予优甲乐+甲癌术后方治疗,通过为期 6 月的治疗、随访,观察患者生活质量量 表(QLQ-C-30)、甲状腺超声、甲功、甲状腺球蛋白、中医证候指标积分、疗效 反应分级、肝肾功的变化,评价患者 DTC 术后应用“甲癌术后方”的临床疗效 和安全性,为“甲癌术后方”应用于 DTC 术后临床管理提供循证医学证据

Objectives of Study:

This study intends to design a single-center, superiority-controlled clinical trial, targeting postoperative patients of differentiated thyroid carcinoma (DTC). 306 patients will be randomly divided into the control group and the treatment group. Patients in the control group will receive standardized levothyroxine (LT4) treatment, while those in the treatment group will be treated with LT4 combined with the "Postoperative thyroid Cancer Chinese medicine decoction " . Through a 6-month treatment and follow-up period, the quality of life scale (QLQ-C-30), thyroid ultrasound, thyroid function tests, thyroid globulin, the integral of TCM syndrome indicators, therapeutic response grading, and changes in liver and kidney functions will be observed. The clinical efficacy and safety of applying the "Postoperative thyroid Cancer Chinese medicine decoction " to postoperative clinical management of DTC patients will be evaluated, providing evidence-based medical evidence for the application of the "Postoperative thyroid Cancer Chinese medicine decoction " in the clinical management of DTC postoperative patients.

药物成份或治疗方案详述:

甲癌术后方药物组成:党参、麦冬、五味子、夏枯草、丹参、白芍、香附、姜黄、玄参、法半夏、女贞子、甘草等

Description for medicine or protocol of treatment in detail:

The composition of the Thyroid Carcinoma postoperative prescription: Codonopsis, Ophiopogon japonicum, Schisandrae fructus, Prunella vulgaris, Salvia miltiorrhiza, Radix paeoniae alba, Rhizoma fragrans, turmeric, scrophularia, Pinellia, Ligustrum, licorice, etc

纳入标准:

①年龄在25-70岁,经手术后病理确诊为DTC;②甲状腺癌术后(或术后碘131治疗后)常规给予优甲乐治疗,TSH抑制值达到指南标准者;③中医辨证属气阴两虚兼肝郁者;④签署知情同意书的患者。

Inclusion criteria

① Patients aged from 25 to 70 years old were diagnosed as DTC by postoperative pathology; ② patients with thyroid cancer after surgery (or after postoperative iodine-131 therapy) routinely treated with Euthyrox, TSH suppression value reached the guideline standard; ③ qi and Yin deficiency combined with liver depression in TCM syndrome differentiation; ④ patients who signed informed consent.

排除标准:

①严重的心、肝、肾等全身性疾病和精神疾病患者; ②对药物所含成分过敏者; ③发现远处转移癌灶; ④妊娠、哺乳期妇女; ⑤正在参加其他临床药物试验者 ⑥不签署知情同意书的患者;符合上述任何一项者,均予以排除。

Exclusion criteria:

① patients with serious systemic diseases such as heart, liver, kidney and mental diseases; ② Allergic to the ingredients contained in the drug; ③ the presence of distant metastasis; ④ pregnant and lactating women; ⑤ those who were participating in other clinical drug trials ⑥ patients who did not sign the informed consent; Those fulfilling any of the above criteria were excluded.

研究实施时间:

Study execute time:

From 2022-05-01

To      2025-05-31

征募观察对象时间:

Recruiting time:

From 2022-07-01

To      2025-05-31

干预措施:

Interventions:

组别:

对照组

样本量:

153

Group:

Control group

Sample size:

干预措施:

优甲乐口服,服用剂量按照DTC诊疗指南抑制标准确定。

干预措施代码:

Intervention:

Euthyrox was administered orally, and the dose was determined according to the inhibition standard of DTC diagnosis and treatment guidelines.

Intervention code:

组别:

试验组

样本量:

153

Group:

treatment group

Sample size:

干预措施:

在优甲乐治疗基础上,加甲癌术后方口服,日1剂。药物组成:党参、麦冬、五味子、夏枯草、丹参、白芍、香附、姜黄、玄参、法半夏、女贞子、甘草等)。

干预措施代码:

Intervention:

On the basis of Euthyrox treatment, the Thyroid Carcinoma postoperative prescription was added orally, 1 dose daily. Drug composition: Codonopsis, ophiopogon, Schisandrae, Prunella vulgaris, salvia miltiorrhiza, Radix paeoniae, Rhizoma fragrans, turmeric, scrophala, Pinellia, Ligustrum, licorice, etc.

Intervention code:

样本总量 Total sample size : 306

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):

Country:

China

Province:

Beijing

City:

单位(医院):

中日友好医院

单位级别:

中日友好医院

Institution/hospital:

China-Japan Friendship Hospital

Level of the institution:

grade A tertiary hospital

测量指标:

Outcomes:

指标中文名:

甲状腺球蛋白

指标类型:

次要指标

Outcome:

Thyroglobulin

Type:

Secondary indicator

测量时间点:

治疗期的第12周

测量方法:

血液检验

Measure time point of outcome:

The 12th week of the treatment period

Measure method:

Blood test

指标中文名:

中医证侯积分

指标类型:

次要指标

Outcome:

TCM Syndrome Score

Type:

Secondary indicator

测量时间点:

治疗期的第12周

测量方法:

计算中医证候积分

Measure time point of outcome:

The 12th week of the treatment period

Measure method:

Calculate the score of TCM syndrome

指标中文名:

甲状腺超声

指标类型:

次要指标

Outcome:

Thyroid ultrasound

Type:

Secondary indicator

测量时间点:

治疗期的第12周

测量方法:

超声检查

Measure time point of outcome:

The 12th week of the treatment period

Measure method:

Ultrasound examination

指标中文名:

甲功

指标类型:

次要指标

Outcome:

Thyroid function

Type:

Secondary indicator

测量时间点:

治疗期的第12周

测量方法:

血液检验

Measure time point of outcome:

The 12th week of the treatment period

Measure method:

Blood test

指标中文名:

疗效反应分级

指标类型:

次要指标

Outcome:

Grade of therapeutic response

Type:

Secondary indicator

测量时间点:

治疗期的第12周

测量方法:

评估疗效反应的级别

Measure time point of outcome:

The 12th week of the treatment period

Measure method:

Evaluate the level of therapeutic response

指标中文名:

生活质量量表QLQ-C-30

指标类型:

主要指标

Outcome:

EORTC QLQ-C30

Type:

Primary indicator

测量时间点:

治疗12周后

测量方法:

填写量表

Measure time point of outcome:

After 12 weeks of treatment

Measure method:

Complete the questionnaire

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:

正在进行

Recruiting

年龄范围:

最小 25
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):

统计人员采用随机数字表计算机产生随机数字序列这一随机化方法,按照 1:1 比例将患者分为试验组和对照组。

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

Patients were assigned to the trial group or the control group in a 1:1 ratio with the use of computer-generated random-number sequences from a random-number table.

盲法:

Blinding:

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):

试验结束后以文章发表的形式进行公开

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

expected to be shared as an article paper after the trial ends

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:

病例记录表采集原始数据

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

The case record form was used to collect the original data.

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