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Investigating the Role of Herbal Plant mixtures in the Management of Poly Cystic Ovary Syndrome (A Randomized double blinded placebo controlled clinical trial
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注册号：

Registration number：

 ChiCTR2100047382 

最近更新日期：

Date of Last Refreshed on：

 2022-02-07 11:44:49 

注册时间：

Date of Registration：

 2021-06-13 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Investigating the Role of Herbal Plant mixtures in the Management of Poly Cystic Ovary Syndrome (A Randomized double blinded placebo controlled clinical trial

Public title：

Investigating the Role of Herbal Plant mixtures in the Management of Poly Cystic Ovary Syndrome (A Randomized double blinded placebo controlled clinical trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Investigating the Role of Herbal Plant mixtures in the Management of Poly Cystic Ovary Syndrome (A Randomized double blinded placebo controlled clinical trial

Scientific title：

Investigating the Role of Herbal Plant mixtures in the Management of Poly Cystic Ovary Syndrome (A Randomized double blinded placebo controlled clinical 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：

申请注册联系人：

Jeza Muhamad Abdul Aziz 

研究负责人：

Jeza Muhamad Abdul Aziz 

Applicant：

Jeza Muhamad Abdul Aziz 

Study leader：

Jeza Muhamad Abdul Aziz 

申请注册联系人电话：

Applicant telephone：

 +9647700559681

研究负责人电话：

Study leader's
telephone：

+9647700559681

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：

 jeza1981@gmail.com

研究负责人电子邮件：

Study leader's E-mail：

 jeza1981@gmail.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

 University of human development

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：

Sulaimani, Kurdistan Regional Government, Iraq

研究负责人通讯地址：

Sulaimani, Kurdistan Regional Government, Iraq

Applicant address：

Sulaimani, Kurdistan Regional Government, Iraq

Study leader's address：

Sulaimani, Kurdistan Regional Government, Iraq

申请注册联系人邮政编码：

Applicant postcode：

 +964

研究负责人邮政编码：

Study leader's postcode：

 +964

申请人所在单位：

伊拉克Baxshin Hospital

Applicant's institution：

Department of Medical Laboratory of Science, College of Health Sciences, University of Human Development, Sulaimani, Kurdistan Regional Government, Iraq 7Baxshin Research Centre, Baxshin Hospital

研究负责人所在单位：

伊拉克Baxshin Hospital

Affiliation of the Leader：

Department of Medical Laboratory of Science, College of Health Sciences, University of Human Development, Sulaimani, Kurdistan Regional Government, Iraq 7Baxshin Research Centre, Baxshin Hospital, Su

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：

 74

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：

Ethical committee of the college of Medicine

Name of the ethic committee：

Ethical committee of the college of Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

 2021-04-27 00:00:00

伦理委员会联系人：

Ass.prof.Dr.Kamaran Awrahman Majeed

Contact Name of the ethic committee：

Ass.prof.Dr.Kamaran Awrahman Majeed

伦理委员会联系地址：

University of Sulaimani, Kurdistan region of Iraq

Contact Address of the ethic committee：

University of Sulaimani, Kurdistan region of Iraq

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：

Nisreen Ghafour Majeed

Primary sponsor：

Nisreen Ghafour Majeed

研究实施负责（组长）单位地址：

Senior Obstetrician and gynecologist ,Baxshen Hospital, Sulaimani, Kurdistan region, Iraq

Primary sponsor's address：

Senior Obstetrician and gynecologist ,Baxshen Hospital, Sulaimani, Kurdistan region, Iraq

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

伊拉克

省(直辖市)：

库尔德斯坦

市(区县)：

Country：

Iraq

Province：

Kurdistan

City：

单位(医院)：

Baxshin Hospital

具体地址：

Malik Mahmood Ring Road Beside Hiwa Hospital,Sulaimani, Kurdistan, Iraq

Institution
hospital：

Baxshin Hospital

Address：

Malik Mahmood Ring Road Beside Hiwa Hospital,Sulaimani, Kurdistan, Iraq

经费或物资来源：

Baxshin Hospital

Source(s) of funding：

Baxshin Hospital

研究疾病：

Poly Cystic Ovary  

Target disease：

Poly Cystic Ovary

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：

 探索性研究/预试验 

Study phase：

0

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

To evaluate if regular taking a special mixture of herbal tea, from ingredients which are known to have role in treating menstrual disturbances, hormonal imbalances and insulin resistance, by women who are diagnosed as PCO, have benefits inform of clinical picture, hormonal profile, lipid profile, insulin resistance and ultrasound findings  

Objectives of Study：

To evaluate if regular taking a special mixture of herbal tea, from ingredients which are known to have role in treating menstrual disturbances, hormonal imbalances and insulin resistance, by women who are diagnosed as PCO, have benefits inform of clinical picture, hormonal profile, lipid profile, insulin resistance and ultrasound findings

药物成份或治疗方案详述：

Participants will be advised to prepare powder as tea, by steeping the container on a glass of hot water, leave it for 10 minutes then drink them without eating or drinking anything one hour before and after, two times daily for two months. During these two months patients will be seen every two weeks for assessing there general wellbeing, will be asked if they notice any adverse effects at the same time to ensure that they are using the materials appropriately. At the end of two months, patients will be reassessed clinically and biochemically as following: 1. blood pressure measurements; 2. Body mass index; 3. Waist hip circumferences; 4. Ferriman score; 5. Blood sample will be sent for total testosterone, free testosterone, DHEA_S, LH, FSH, AMH serum prolactin, lipid profile, fasting blood glucose and insulin as well as ultrasound by the same person and machine for size of ovary and number of immature follicles.  

Description for medicine or protocol of treatment in detail：

Participants will be advised to prepare powder as tea, by steeping the container on a glass of hot water, leave it for 10 minutes then drink them without eating or drinking anything one hour before and after, two times daily for two months. During these two months patients will be seen every two weeks for assessing there general wellbeing, will be asked if they notice any adverse effects at the same time to ensure that they are using the materials appropriately. At the end of two months, patients will be reassessed clinically and biochemically as following: 1. Blood pressure measurements; 2. Body mass index; 3. Waist hip circumferences; 4. Ferriman score; 5. Blood sample will be sent for total testosterone, free testosterone, DHEA_S, LH, FSH, AMH serum prolactin, lipid profile, fasting blood glucose and insulin as well as ultrasound by the same person and machine for size of ovary and number of immature follicles.  

纳入标准：

Inclusion criteria

排除标准：

1. Menarche less than one year;
2. Who have any chronic illness example: renal disease, diabetes, hypertension, thyroid disease, or bleeding tendency;
3. Who are on long term pharmacological treatments;
4. Who are on conventional therapy for PCOS;
5. Who are pregnant;
6. Those who are using any herbal treatment.

Exclusion criteria：

1. Menarche less than one year;
2. Who have any chronic illness example: renal disease, diabetes, hypertension, thyroid disease, or bleeding tendency;
3. Who are on long term pharmacological treatments;
4. Who are on conventional therapy for PCOS;
5. Who are pregnant;
6. Those who are using any herbal treatment.

研究实施时间：

Study execute time：

从 From 2021-05-20 00:00:00至 To 2022-05-20 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2021-05-20 00:00:00 至 To 2022-02-20 00:00:00

干预措施：

Interventions：

组别：

1

样本量：

 30

Group：

1

Sample size：

干预措施：

tea herbal

干预措施代码：

Intervention：

tea herbal

Intervention code：

组别：

2

样本量：

 30

Group：

2

Sample size：

干预措施：

placebo

干预措施代码：

Intervention：

placebo

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 伊拉克

省(直辖市)：

 库尔德斯坦 

市(区县)：

 苏莱曼尼 

Country：

Iraq

Province：

Kurdistan

City：

Sulaimani

单位(医院)：

 Baxshin 

单位级别：

 Tertiary 

Institution
hospital：

Baxshin

Level of the institution：

Tertiary

测量指标：

Outcomes：

指标中文名：

The primary outcome of the current research will be the level of the hormone (FSH, LH, AMH, total testosterone, free testosterone, DHEAs, lipid profile, fasting insulin, TSH, FBS, sex hormone binding globulin, prolactin, FTSH)

指标类型：

主要指标

Outcome：

The primary outcome of the current research will be the level of the hormone (FSH, LH, AMH, total testosterone, free testosterone, DHEAs, lipid profile, fasting insulin, TSH, FBS, sex hormone binding globulin, prolactin, FTSH)

Type：

Primary indicator

测量时间点：

two month

测量方法：

Measure time point of outcome：

two month

Measure method：

指标中文名：

The secondary outcome will be the other clinical measurements including (Blood pressure, BMI, WHR)

指标类型：

次要指标

Outcome：

The secondary outcome will be the other clinical measurements including (Blood pressure, BMI, WHR)

Type：

Secondary indicator

测量时间点：

two month

测量方法：

Measure time point of outcome：

two month

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

Blood

组织：

Sample Name：

Blood

Tissue：

人体标本去向

 使用后保存  

说明

Fate of sample：

Preservation 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 16 岁 years
最大 Max age 40 岁 years

性别：

男性

Gender：

Male

随机方法（请说明由何人用什么方法产生随机序列）：

Bahar Factory

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

Bahar Factory

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：

Double blind

Blinding：

Double blind

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）：

available from the chief investigator upon reasonable request

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

available from the chief investigator upon reasonable request

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：

Data collection for clinical research involves gathering variables relevant to research hypotheses. These variables (‘patient parameters,’ ‘data items,’ ‘data elements,’ or ‘questions’) are aggregated into data-collection forms (‘Case Report Forms’ or CRFs) for study implementation.

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

Data collection for clinical research involves gathering variables relevant to research hypotheses. These variables (‘patient parameters,’ ‘data items,’ ‘data elements,’ or ‘questions’) are aggregated into data-collection forms (‘Case Report Forms’ or CRFs) for study implementation.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2021-06-13 04:42:00
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