ChiCTR2100044108 版本V1.4 版本创建时间2021/07/17 18:14:16 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2100044108 

最近更新日期：

Date of Last Refreshed on：

 2021-07-17 18:12:33 

注册时间：

Date of Registration：

 2021-03-11 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

调经促孕针刺结合火龙灸治疗卵巢储备功能减退的病例序列研究

Public title：

A case sequence study of acupuncture for regulating menstruation and promoting pregnancy combined with fire dragon moxibustion for treatment of ovarian reserve hypofunction

注册题目简写：

English Acronym：

研究课题的正式科学名称：

调经促孕针刺结合火龙灸治疗卵巢储备功能减退的病例序列研究

Scientific title：

A case sequence study of acupuncture for regulating menstruation and promoting pregnancy combined with fire dragon moxibustion for treatment of ovarian reserve hypofunction

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：

ChiMCTR2100004560

申请注册联系人：

何婷 

研究负责人：

何婷 

Applicant：

He Ting 

Study leader：

He Ting 

申请注册联系人电话：

Applicant telephone：

 +86 13595368240

研究负责人电话：

Study leader's
telephone：

+86 13595368240

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：

 570534779@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 570534779@qq.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：

贵州省贵阳市云岩区宝山北路71号

研究负责人通讯地址：

贵州省贵阳市云岩区宝山北路71号

Applicant address：

71 Baoshan Road North, Yunyan District, Guiyang, Guizhou

Study leader's address：

71 Baoshan Road North, Yunyan District, Guiyang, Guizhou

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：

贵州中医药大学第一附属医院

Applicant's institution：

The First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine

研究负责人所在单位：

贵州中医药大学第一附属医院

Affiliation of the Leader：

The First Affiliated Hospital of Guizhou University of Traditional 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：

 K2020-039

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：

贵州中医药大学第一附属医院伦理委员会

Name of the ethic committee：

Ethics Committee of the First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

 2020-11-12 00:00:00

伦理委员会联系人：

李红日

Contact Name of the ethic committee：

LI Hongri

伦理委员会联系地址：

贵州省贵阳市宝山北路71号

Contact Address of the ethic committee：

71 Baoshan Road North, Guiyang, Guizhou

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：

贵州中医药大学第一附属医院

Primary sponsor：

The First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine

研究实施负责（组长）单位地址：

贵州省贵阳市云岩区宝山北路71号

Primary sponsor's address：

71 Baoshan Road North, Yunyan District, Guiyang, Guizhou

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

贵州

市(区县)：

贵阳

Country：

China

Province：

Guizhou

City：

Guiyang

单位(医院)：

贵州中医药大学第一附属医院

具体地址：

云岩区宝山北路71号

Institution
hospital：

The First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine

Address：

71 Baoshan Road North, Yunyan District

经费或物资来源：

贵州中医药大学科研项目

Source(s) of funding：

Scientific Research Project of Guizhou University of Traditional Chinese Medicine

研究疾病：

卵巢储备功能减退  

Target disease：

Decreased ovarian reserve

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：

 其它 

Study phase：

N/A

研究设计：

非随机对照试验 

Study design：

Non randomized control 

研究目的：

主要目标是初步探索调经促孕针刺结合火龙灸治疗卵巢储备功能减退的有效性和安全性。  

Objectives of Study：

The main goal is to initially explore the effectiveness and safety of acupuncture for regulating menstruation and promoting pregnancy combined with fire dragon moxibustion in the treatment of ovarian reserve hypofunction.

药物成份或治疗方案详述：

调经促孕针刺 针具：针具和电针仪均来自于苏州医疗用品厂有限公司（注册证号：苏食药监械生产许2001-0020号；注册证编号：苏械注准20162270970）。针具型号：华佗牌一次性针灸针，长75mm，粗0.30mm；长40mm，粗0.25mm；长25mm，粗0.25mm。电针仪型号：华佗牌电子针疗仪SDZ-II型。 取穴：穴组①：百会、神庭、中脘、关元及（双侧）本神、天枢、大赫、卵巢（脐下3寸，前正中线旁开3寸）、足三里、三阴交、太溪、太冲穴；穴组②：（双侧）肾俞、次髎穴。详细参照2006年的中国国家标准（GB/T-11246-2006）《腧穴名称与定位》。 操作：两穴组交替使用，采用一次性无菌针灸针常规消毒后针刺。百会、本神、神庭穴采用0.25×25mm针灸针以15°角向后平刺10-15mm，只捻转不提插，捻转频率为150次/min，持续1min；中脘、天枢、关元、大赫、卵巢、足三里、肾俞穴采用0.25×40mm针灸针直刺20-30mm；三阴交、太溪、太冲穴采用0.25×25mm针灸针直刺10-15mm；次髎穴采用0.30×75mm针灸针约呈45°角向正中线斜下刺40-50mm，入第2骶后孔中，使针感向会阴部传导。所有腧穴均要求得气，留针30min。电针：在双侧肾俞、中髎的针柄上横向连接电针仪电极。电针参数：疏密波；2/15Hz，电流强度以患者能耐受、不产生不适感为度，留针30 min。 疗程：穴组①、穴组②交替针刺，每次留针30min，每周间隔治疗3次，共12周。 火龙灸： 材料：艾条为江苏康美制药有限公司生产的清艾条（生产批号：国药准字Z32020253）；患者自备搅碎的生姜末。 取穴：背部督脉及两侧膀胱经区域，腹部任脉及冲脉区域。详细参照2006年的中国国家标准（GB/T-11246-2006）《腧穴名称与定位》。 操作：患者先取俯卧位，取背部督脉及两侧膀胱经区域，涂抹生姜汁，然后铺上一层宣纸，宣纸上铺生姜末，厚度为2-3cm，最后在生姜上铺艾绒，厚度为2-3cm，点燃艾绒，施灸1小时。施灸结束后，患者取仰卧位，按上述方法施灸腹部任脉及冲脉区域，施灸1小时。 疗程：每次治疗时间约为2小时，每周治疗1次，连续治疗12周。 

Description for medicine or protocol of treatment in detail：

Acupuncture for regulating menstruation and promoting pregnancy Needles: Needles and electroacupuncture instruments are from Suzhou Medical Supplies Factory Co., Ltd. (Registration number: Su Food and Drug Administration Approval No. 2001-0020; Registration Certificate No.: Su Xie Zhuzhun 20162270970). Needle model: Huatuo brand disposable acupuncture needle, length 75mm, thickness 0.30mm; length 40mm, thickness 0.25mm; length 25mm, thickness 0.25mm. Electroacupuncture instrument model: Huatuo brand electronic acupuncture instrument SDZ-II. Acupoint selection: acupoint group 1: Baihui, Shenting, Zhongwan, Guanyuan and (bilateral) Benshen, Tianshu, Dahe, ovary (3 inches below the umbilicus, 3 inches beside the front midline), Zusanli, Sanyinjiao, Taixi, and Taichong points; point group 2: (bilateral) Shenshu and Ciliao points. For details, please refer to the 2006 Chinese National Standard (GB/T-11246-2006) "Acupoint Names and Positions". Operation: The two-point groups are used alternately, and acupuncture is performed with sterile disposable acupuncture needles after routine disinfection. Use 0.25x25mm acupuncture needles at Baihui, Benshen, and Shenting to puncture 10-15mm backwards at an angle of 15 degrees. Twist only without lifting. The twisting frequency is 150 times/min for 1 min; Zhongwan and Tianshu Use 0.25 x 40mm acupuncture needles to directly puncture 20-30mm with 0.25 x 40mm acupuncture needles at Guanyuan, Dahe, Ovarian, Zusanli and Shenshu points; puncture 10-15mm with 0.25 x 25mm acupuncture needles at Sanyinjiao, Taixi and Taichong points; A 0.30 x 75mm acupuncture needle was used to puncture 40-50mm obliquely towards the midline at an angle of about 45 degrees, into the second posterior foramen, so that the needle sensation was transmitted to the perineum. All acupoints are required to get qi, and the needle should be kept for 30 minutes. Electroacupuncture: Connect the electrodes of the electroacupuncture instrument across the needle handles of both Shenshu and Zhongliu. Electroacupuncture parameters: density wave; 2/15Hz, the current intensity should be tolerable by the patient without discomfort, and the needle should be retained for 30 minutes. Course of treatment: alternating acupuncture in the acupoint group 1 and the acupoint group 2, leaving the needle for 30 minutes each time, and treatment is performed 3 times a week for 12 weeks. Fire dragon moxibustion Materials: Moxa sticks are Qingmoxa sticks produced by Jiangsu Kangmei Pharmaceutical Co., Ltd. (manufacturing batch number: Z32020253); patients prepare crushed ginger powder. Acupoint selection: the governor channel on the back and the bladder meridian area on both sides, and the abdomen Ren channel and Chongmai area. For details, please refer to the 2006 Chinese National Standard (GB/T-11246-2006) "Acupoint Names and Positions". Operation: The patient first takes the prone position, takes the governor meridian on the back and the bladder meridian area on both sides, smears ginger juice, and then spreads a layer of rice paper with ground ginger with a thickness of 2-3cm, and finally spreads moxa on the ginger, thickness For 2-3cm, light moxa and apply moxibustion for 1 hour. After the moxibustion is over, the patient takes the supine position and moxibuses the region of the abdomen and Chongmai as described above for 1 hour. Course of treatment: each treatment time is about 2 hours, once a week, continuous treatment for 12 weeks. 

纳入标准：

（1）符合诊断标准：①18岁≤年龄＜40岁；②临床表现：月经异常，包括月经稀发或经量减少，严重者可出现闭经及不孕；同时可伴有围绝经期症状，如腰膝酸软、头晕耳鸣、失眠多梦、面部潮红、烘热汗出、性情烦躁、神疲乏力、性欲减退等。③10U/L＜FSH＜25U/L；④AMH＜1.1ng/mL；⑤窦卵泡计数＜7个。具备①、②和③-⑤中的任意1项即可诊断。
（2）签署知情同意书，自愿参加本项研究。
注：同时符合以上2项的患者，方可纳入本项研究。

Inclusion criteria

1. Meet the diagnostic criteria:
(1)Aged <=18 years and <40 years;
(2)Clinical manifestations: abnormal menstruation, including oligomenorrhea or decreased menstrual flow, severe cases may cause amenorrhea and infertility; at the same time, it may be accompanied by perimenopausal symptoms, such as Soreness of waist and knees, dizziness, tinnitus, insomnia, facial flushing, hot sweating, irritability, fatigue, loss of libido, etc.
(3)10U/L < FSH < 25U/L;
(4)AMH < 1.1ng/mL;
(5)Antral follicle count < 7. It can be diagnosed with any one of (1), (2) and (3)-(5).
2. Sign informed consent and voluntarily participate in this research.
Note: Patients who meet the above 2 items at the same time can be included in this study.

排除标准：

①因卵巢局部手术引起者；
②因服用激素、免疫抑制剂等药物引起的卵巢功能减退者；
③日常生活及工作中有长时间的放射线及化学毒物接触史者；
④卵巢肿瘤、先天性生殖器官发育异常者；
⑤炎症、肿瘤疾病、严重心脑血管疾病或一般状况差，无法配合者；
⑥装有心脏起搏器，严重惧针、晕针或金属过敏者。

Exclusion criteria：

1. Caused by local ovarian surgery;
2. Patients with hypofunction of ovaries caused by taking hormones, immunosuppressants and other drugs;
3. Persons who have a long history of exposure to radiation and chemical poisons in daily life and work;
4. Patients with ovarian tumors and congenital reproductive organ development abnormalities
5. Inflammation, tumor disease, severe cardiovascular and cerebrovascular disease or poor general condition, unable to cooperate;
6. Those who are equipped with a pacemaker and are severely afraid of needles, fainting or metal allergies.

研究实施时间：

Study execute time：

从 From 2020-07-01 00:00:00至 To 2022-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2021-04-01 00:00:00 至 To 2022-08-31 00:00:00

干预措施：

Interventions：

组别：

治疗组

样本量：

 10

Group：

therapy group

Sample size：

干预措施：

电针结合火龙灸

干预措施代码：

Intervention：

Electroacupuncture combined with fire dragon moxibustion

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 贵州 

市(区县)：

 贵阳 

Country：

China

Province：

Guizhou

City：

Guiyang

单位(医院)：

 贵州中医药大学第一附属医院 

单位级别：

 三级甲等 

Institution
hospital：

The First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

血清激素水平（FSH、AMH）、窦卵泡计数

指标类型：

主要指标

Outcome：

Serum hormone levels (FSH, AMH), AFC

Type：

Primary indicator

测量时间点：

第12周

测量方法：

抽血、B超

Measure time point of outcome：

Week 12

Measure method：

Blood draw

指标中文名：

月经情况（周期、经量、经色）

指标类型：

次要指标

Outcome：

Menstrual condition (cycle, menstrual volume, menstrual color)

Type：

Secondary indicator

测量时间点：

第12周

测量方法：

问诊

Measure time point of outcome：

Week 12

Measure method：

inquiry

指标中文名：

焦虑自评量表评分

指标类型：

次要指标

Outcome：

Self-rating anxiety scale

Type：

Secondary indicator

测量时间点：

第12周

测量方法：

问卷

Measure time point of outcome：

Week 12

Measure method：

Questionnaire

指标中文名：

安全性评价

指标类型：

次要指标

Outcome：

Safety evaluation

Type：

Secondary indicator

测量时间点：

每次治疗完进行回顾性评价

测量方法：

Measure time point of outcome：

Retrospective evaluation after each treatment

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：

Recruiting status：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 39 岁 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）：

非随机

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

Non-randomization

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

由于针灸临床的特殊性，不能采用严格标准的盲法进行评价，故由不参与临床操作的第三者进行疗效评价；实行疗效评价者、操作者及统计人员三分离。

Blinding：

Due to the particularity of acupuncture and moxibustion, a strict standard blind method cannot be used for evaluation. Therefore, a third party who does not participate in the clinical operation will evaluate the curative effect; the curative effect evaluator, the operator and the statistician are separated.

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

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）：

试验完成后公开，内容包括原始记录数据和研究计划书

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

After the test is completed, it will be published, including the original record data and research plan

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

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

Case Record Form

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2021-03-11 04:56:03