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补肾化痰方联合八段锦治疗肾虚痰湿型IR-PCOS的临床疗效观察
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注册号:

Registration number:

ChiCTR2100043415 

最近更新日期:

Date of Last Refreshed on:

2021-06-05 

注册时间:

Date of Registration:

2021-02-15 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

补肾化痰方联合八段锦治疗肾虚痰湿型IR-PCOS的临床疗效观察 

Public title:

Efficacy of Bushen Huatan Decoction combined with Baduanjin in the treatment of polycystic ovary syndrome with insulin resistance (IR-PCOS), kidney deficiency and phlegm dampness: protocol for a randomized controlled pilot trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

补肾化痰方联合八段锦治疗肾虚痰湿型IR-PCOS的临床疗效观察 

Scientific title:

Efficacy of Bushen Huatan Decoction combined with Baduanjin in the treatment of polycystic ovary syndrome with insulin resistance (IR-PCOS), kidney deficiency and phlegm dampness: protocol for a randomized controlled pilot trial 

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:

ChiMCTR2100004448 

申请注册联系人:

钱海晴 

研究负责人:

王利红 

Applicant:

Qian Haiqing 

Study leader:

Wang Lihong 

申请注册联系人电话:

Applicant telephone:

+86 18260091618 

研究负责人电话:

Study leader's telephone:

+86 15250358008 

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:

qhq779672731@126.com 

研究负责人电子邮件:

Study leader's E-mail:

wanglihong8008@163.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:

江苏省张家港市长安南路77号张家港市中医医院 

研究负责人通讯地址:

江苏省张家港市长安南路77号张家港市中医医院 

Applicant address:

Zhangjiagang TCM Hospital Affiliated to Nanjing University of Chinese Medicine,77 Chang'an Road South, Zhangjiagang, Jiangsu, China 

Study leader's address:

Zhangjiagang TCM Hospital Affiliated to Nanjing University of Chinese Medicine,77 Chang'an Road South, Zhangjiagang, Jiangsu, China 

申请注册联系人邮政编码:

Applicant postcode:

215600 

研究负责人邮政编码:

Study leader's postcode:

215600 

申请人所在单位:

南京中医药大学张家港市附属医院 

Applicant's institution:

Zhangjiagang TCM Hospital Affiliated to Nanjing University of Chinese Medicine 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

2020-80-2 

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:

南京中医药大学张家港市附属医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Zhangjiagang TCM Hospital Affiliated to Nanjing University of Chinese Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2021-01-18 

伦理委员会联系人:

钱洁 

Contact Name of the ethic committee:

Qian Jie 

伦理委员会联系地址:

江苏省张家港市长安南路77号张家港市中医医院 

Contact Address of the ethic committee:

Zhangjiagang TCM Hospital Affiliated to Nanjing University of Chinese Medicine,77 Chang'an Road South, Zhangjiagang, Jiangsu, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 512-56380935 

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:

南京中医药大学张家港市附属医院 

Primary sponsor:

Zhangjiagang TCM Hospital Affiliated to Nanjing University of Chinese Medicine 

研究实施负责(组长)单位地址:

江苏省张家港市长安南路77号张家港市中医医院 

Primary sponsor's address:

Zhangjiagang TCM Hospital Affiliated to Nanjing University of Chinese Medicine,77 Chang'an Road South, Zhangjiagang, Jiangsu, 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):

江苏

市(区县):

张家港

Country:

China

Province:

Jiangsu

City:

Zhangjiagang

单位(医院):

南京中医药大学张家港市附属医院

具体地址:

长安南路77号张家港市中医医院

Institution
hospital:

Zhangjiagang TCM Hospital Affiliated to Nanjing University of Chinese Medicine

Address:

Zhangjiagang TCM Hospital Affiliated to Nanjing University of Chinese Medicine,77 Chang'an Road South

经费或物资来源:

南京中医药大学张家港市附属医院 

Source(s) of funding:

Zhangjiagang TCM Hospital Affiliated to Nanjing University of Chinese Medicine 

研究疾病:

多囊卵巢综合征 

Target disease:

Polycystic ovarian syndrome 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

上市后药物 

Study phase:

研究目的:

观察“补肾化痰方”联合八段锦治疗肾虚痰湿型IR-PCOS的临床疗效,明确此综合干预方案对IR-PCOS患者月经周期调整、胰岛素抵抗改善以及糖代谢紊乱纠正方面的有效性,以期形成中药-行为联合干预治疗IR-PCOS的具体方案,达到对患者进行长期管理、改善其临床症状及体征、解决生育相关问题、维护健康及提高生活质量的目的。 

Objectives of Study:

To observe the clinical efficacy of "Kidney-Tonifying and Phlegm-Dispelling Prescription" combined with "Baduanjin Exercise" in the treatment of "kidney deficiency and phlegm dampness" IR-PCOS.To determine the effectiveness of this comprehensive intervention scheme for patients with IR-PCOS in terms of menstrual cycle regulation, insulin resistance improvement and glucose metabolism disorder correction.Hoping to develop a specific treatment plan combined with TCM and behavior for IR-PCOS.To achieve the long-term management of patients, improve their clinical symptoms and signs, solve fertility related problems, maintain health and improve the quality of life. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

(1)年龄:18-35岁中国女性; (2)BMI≥25Kg/m2; (3)符合西医诊断标准(IR-PCOS); (4)符合中医辨证诊断标准(肾虚痰湿证); (5)符合胰岛素抵抗诊断标准:HOMA-IR≥2.29; (6)治疗前3个月无激素类药物及影响糖代谢类药物使用史; (7)志愿参加并知情同意。 

Inclusion criteria

(1) Chinese women aged from 18 to 35 years old. (2) BMI over 25.0 kg/m2. (3) Confirmed diagnosis of PCOS according to the 2003 Rotterdam criteria: (a) irregular menstruation cycles (a periodic interval > 35 days or < 8 cycles in a year) or amenorrhea (a periodic interval > 90 days) or abnormal uterine bleeding; (b) clinical manifestations of hyperandrogenism (hirsutism in mainland China is taken as Ferriman-Gallwey score >= 5) and/or hyperandrogenemia [free androgen index (FAI)=total testosterone (nmol/L)/SHBG (nmol/L) x 100 >4.5]; and (c) transvaginal ultrasonography showing PCOM: the number of follicles with a diameter of 2-9 mm in one or both ovaries >= 12, and/or ovarian volume >= 10 ml [ovarian volume calculation: 0.5* long diameter (cm) * diameter (cm) * anteroposterior diameter (cm)]. Among all the above, (a) is a necessary condition, and matching one of (b) or (c) represents suspected PCOS, which then requires ruling out other factors and diseases that may cause hyperandrogenism and ovulation dysfunction. (4) In line with the diagnosis criteria of TCM syndrome differentiation: kidney deficiency and phlegm dampness. (5) Confirming the diagnosis of insulin resistance: the criteria of IR are defined according to the homeostatic model assessment of insulin resistance (HOMA-IR) [fasting plasma glucose (mmol/l) * fasting serum insulin (uIU/ml)/22.5]. A value >= 2.29 is considered to be indicative of IR. (6) No history of using hormone drugs or drugs that affect glucose metabolism within the 3 months prior to treatment. (7) Volunteer to participate in this trial and give informed consent. 

排除标准:

(1)合并其他与本病相关内分泌疾患(如库欣综合征、先天性肾上腺皮质增生症、21-羟化酶缺乏症、高泌乳素血症、未矫正的甲状腺疾患、1型或2型糖尿病等); (2)合并生殖系先天畸形或缺陷、生殖系器质性病变(如子宫肌瘤、卵巢囊肿等); (3)合并生殖系恶性肿瘤(如子宫内膜癌、宫颈癌等); (4)合并生殖器炎症、生殖器结核、盆腔炎性疾病; (5)夫妻双方任意一方有梅毒、艾滋等性传播疾病; (6)合并心脑血管、肝、肾和造血系统严重原发性疾病及精神性疾患; (7)合并染色体异常,或处于妊娠期、哺乳期; (8)近3个月内合并其他用药史(包括激素、影响糖代谢的药物、中药或针灸等); (9)对本研究所使用药物过敏; (10)正在参加其他临床试验。 

Exclusion criteria:

(1) Patients with any other endocrine diseases related to this disease (such as Cushing's syndrome, congenital adrenal hyperplasia, 21-hydroxylase deficiency, hyperprolactinemia, uncorrected thyroid disease, type 1 or type 2 diabetes mellitus, etc. ). (2) Patients with congenital malformations or defects of the reproductive system, organic lesions of the reproductive system (such as uterine fibroids, ovarian cysts, etc. ). (3) Patients with reproductive malignancies (such as endometrial cancer, cervical cancer, etc. ). (4) Patients with genital inflammation, genital tuberculosis, and pelvic inflammatory disease. (5) One of the spouses has a sexually transmitted disease such as syphilis and AIDS. (6) Patients with serious primary diseases of the cardiovascular, cerebrovascular, liver, kidney and hematopoietic systems or psychoses. (7) Patients with chromosomal abnormalities, pregnancy or lactation. (8) Interventions of any other medication treatments, including hormone drugs, drugs that will affect glucose metabolism, Chinese herbal prescriptions or acupuncture in the previous 3 months. (9) Patients allergic to the drugs used in this study. (10) Patients in other clinical trials at the same time. 

研究实施时间:

Study execute time:

From2021-01-01To 2023-01-01 

征募观察对象时间:

Recruiting time:

From2021-03-01To 2022-09-01 

干预措施:

Interventions:

组别:

治疗A组

样本量:

38

Group:

Group A

Sample size:

干预措施:

单纯给予盐酸二甲双胍片口服

干预措施代码:

Intervention:

metformin at a dose of 500 mg per meal, 3 times per day

Intervention code:

组别:

治疗B组

样本量:

38

Group:

Group B

Sample size:

干预措施:

单纯给予中药补肾化痰方口服

干预措施代码:

Intervention:

BSHTD at a total dose of 400 ml per day, divided into 2 oral

Intervention code:

组别:

治疗C组

样本量:

38

Group:

Group C

Sample size:

干预措施:

单纯给予八段锦生活方式干预

干预措施代码:

Intervention:

Baduanjin exercise for 30 minutes per day

Intervention code:

组别:

治疗D组

样本量:

38

Group:

Group D

Sample size:

干预措施:

给予补肾化痰方联合盐酸二甲双胍片(格华止)口服

干预措施代码:

Intervention:

BSHTD combined with metformin

Intervention code:

组别:

治疗E组

样本量:

38

Group:

Group E

Sample size:

干预措施:

给予补肾化痰方口服联合八段锦生活方式干预

干预措施代码:

Intervention:

BSHTD combined with Baduanjin exercise

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

江苏 

市(区县):

张家港 

Country:

China 

Province:

Jiangsu 

City:

Zhangjiagang 

单位(医院):

南京中医药大学附属张家港市中医医院 

单位级别:

三级甲等 

Institution
hospital:

Zhangjiagang TCM Hospital Affiliated to Nanjing University of Chinese Medicine  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

胰岛素抵抗指数

指标类型:

主要指标 

Outcome:

HOMA-IR

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

口服糖耐量试验

指标类型:

主要指标 

Outcome:

OGTT

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

胰岛素释放试验

指标类型:

主要指标 

Outcome:

INS

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

基础性激素水平

指标类型:

次要指标 

Outcome:

the levels of basic serum sex hormones

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

排卵率

指标类型:

次要指标 

Outcome:

the ovulation rate in each menstrual cycle

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

临床妊娠率

指标类型:

次要指标 

Outcome:

the clinical pregnancy rate

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

体重指数

指标类型:

次要指标 

Outcome:

BMI

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

游离睾酮指数

指标类型:

次要指标 

Outcome:

FAI

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

多毛评分

指标类型:

次要指标 

Outcome:

Ferriman-Gallwey 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:

TCM syndrome 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:

血常规

指标类型:

副作用指标 

Outcome:

routine blood examination

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

尿粪常规

指标类型:

副作用指标 

Outcome:

routine urine and stool tests

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肝肾功能

指标类型:

副作用指标 

Outcome:

hepatic and renal function

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

心电图

指标类型:

副作用指标 

Outcome:

ECG examination

Type:

Adverse events 

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:

尿液

组织:

Sample Name:

Urine

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:

粪便

组织:

Sample Name:

Stool

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 years
最大 Max age years

性别:

女性

Gender:

Female

随机方法(请说明由何人用什么方法产生随机序列):

SPSS 25.0软件的随机数生成器来执行随机化过程。

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

use a random number generator of the Statistical Package for Social Sciences (SPSS) version 25.0 to carry out the randomization process.

盲法:

未说明

Blinding:

Not stated

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

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):

网络平台或杂志社投稿 请阅读网页注册指南中关于 原始数据共享 的内容。

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

submit articles to online platforms or magazines

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

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

Case Record Form(CRF)

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2021-02-15
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