ChiCTR2300079249 版本V1.4 版本创建时间2024/01/09 17:03:56 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：

 ChiCTR2300079249 

最近更新日期：

Date of Last Refreshed on：

 2024-01-08 17:25:24 

注册时间：

Date of Registration：

 2023-12-28 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Interventional study

Public title：

The determination of the comparative effect of ertugliflozin, pioglitazone, and metformin in patients of nonalcoholic fatty liver diseases in type 2 diabetes mellitus.

注册题目简写：

English Acronym：

研究课题的正式科学名称：

The determination of the comparative effect of ertugliflozin, pioglitazone, and metformin in patients of nonalcoholic fatty liver diseases in type 2 diabetes mellitus.

Scientific title：

The determination of the comparative effect of ertugliflozin, pioglitazone, and metformin in patients of nonalcoholic fatty liver diseases in type 2 diabetes mellitus.

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：

ADIL KHALIQ 

研究负责人：

HARRON BADSHAH 

Applicant：

ADIL KHALIQ 

Study leader：

HAROON BADSHAHH 

申请注册联系人电话：

Applicant telephone：

 +92 313 9668112

研究负责人电话：

Study leader's
telephone：

+92 340 5840121

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：

 adilkhaliq@awkum.edu.pk

研究负责人电子邮件：

Study leader's E-mail：

 hbadshah@awkum.edu.pk

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：

MARDAN, KHYBER PAKHTUN KHWA, PAKISTAN

研究负责人通讯地址：

MARDAN, KHYBER PAKHTUN KHWA, PAKISTAN

Applicant address：

MARDAN, KHYBER PAKHTUN KHWA, PAKISTAN

Study leader's address：

MARDAN, KHYBER PAKHTUN KHWA, PAKISTAN

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：

DEPARTMENT OF PHARMACY ABDUL WALI KHAN UNIVERSITY MARDAN KYBERPAKHTUNKHWA PAKISTAN

Applicant's institution：

DEPARTMENT OF PHARMACY ABDUL WALI KHAN UNIVERSITY MARDAN KYBERPAKHTUNKHWA

研究负责人所在单位：

DEPARTMENT OF PHARMACY ABDUL WALI KHAN UNIVERSITY MARDAN KYBERPAKHTUNKHWA

Affiliation of the Leader：

DEPARTMENT OF PHARMACY ABDUL WALI KHAN UNIVERSITY MARDAN KYBERPAKHTUNKHWA

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：

 DHQH/2022/04-33

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：

DISTRICT HEADQUARTER HOSPITAL NOWSHERA ETHICAL COMMITTE

Name of the ethic committee：

DISTRICT HEADQUARTER HOSPITAL NOWSHERA ETHICAL COMMITTE

伦理委员会批准日期：

Date of approved by ethic committee：

 2023-08-14 00:00:00

伦理委员会联系人：

DR MUJTABA ALI

Contact Name of the ethic committee：

DR AFZAL ASGHAR

伦理委员会联系地址：

NOWSHERA KALAN, NOWSHERA, KYBERPAKHTUNKHWA, PAKISTAN

Contact Address of the ethic committee：

DISTRICT HEADQUARTER HOSPITAL NOWSHERA ETHICAL COMMITTE

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +92 345 8949385

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：

ADIL KHALIQ

Primary sponsor：

ADIL KHALIQ

研究实施负责（组长）单位地址：

MARDAN, KHYBER PAKHTUN KHWA, PAKISTAN

Primary sponsor's address：

MARDAN, KHYBER PAKHTUN KHWA, PAKISTAN

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

nil

省(直辖市)：

nil

市(区县)：

Country：

Pakistan

Province：

KHYBER PAKHTUN KHWA

City：

Mardan

单位(医院)：

nil

具体地址：

nil

Institution
hospital：

Abdul Wali Khan University

Address：

Toru Road

经费或物资来源：

NIL

Source(s) of funding：

SELF FUNDING

研究疾病：

Non-Alcoholic fatty liver diseases with type 2 diabetes mellitus  

Target disease：

Liver enzyme function deterioration/ Abnormal liver function

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：

 治疗新技术临床试验 

Study phase：

New Treatment Measure Clinical Study

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

The purpose of the study is to determine the effect of ertugliflozin, pioglitazone, and metformin in the improvement of nonalcoholic fatty liver diseases with type 2 diabetes mellitus. Other outcomes include improvement in an elevated liver enzyme and blood cholesterol as well as a change in the quality of life of the patient.  

Objectives of Study：

The aim and objective of this study is to evaluate the effect of ertugliflozin on Non alcoholic fatty liver diseases patients with type 2 diabetes mellitus along with its impact on the function of liver enzymes

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

The standard drug will be used for this study is pioglitazone 30mg and metformin 500mg oral once daily for 6 months.

Inclusion criteria

Participants for this randomize control trail must be Adult patients with age above 20 years and less than 70 years diagnosed with non alcoholic fatty liver diseases along with type 2 diabetes mellitus.

排除标准：

Participants not having non alcoholic fatty liver diseases along with type 2 diabetes mellitus, not willing to participate and the patient having elevated liver enzyme with any other risk factor such as hepatitis or other viral infection.

Exclusion criteria：

Participants not having non alcoholic fatty liver diseases along with type 2 diabetes mellitus, not willing to participate and the patient having elevated liver enzyme with any other risk factor such as hepatitis or other viral infection.

研究实施时间：

Study execute time：

从 From 2024-01-01 00:00:00至 To 2024-08-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2024-01-01 00:00:00 至 To 2024-01-31 00:00:00

干预措施：

Interventions：

组别：

Control drug

样本量：

 60

Group：

Pioglitazone (Control)

Sample size：

干预措施：

To determine the effect of pioglitazone a control in patients of nonalcoholic fatty liver diseases with type 2 diabetes mellitus.

干预措施代码：

Intervention：

Pioglitazone

Intervention code：

组别：

Control drug

样本量：

 60

Group：

Metformin (Control)

Sample size：

干预措施：

To determine the effect of metformin a control in patients of nonalcoholic fatty liver diseases with type 2 diabetes mellitus.

干预措施代码：

Intervention：

Metformin

Intervention code：

组别：

Test drug

样本量：

 60

Group：

Ertugliflozin (Test drug)

Sample size：

干预措施：

To determine the effect of ertugliflozin a control in patients of nonalcoholic fatty liver diseases with type 2 diabetes mellitus.

干预措施代码：

Intervention：

Ertugliflozin

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 Khberpakhtunkhwa

省(直辖市)：

 Khberpakhtunkhwa 

市(区县)：

 Nowshera 

Country：

Pakistan

Province：

Khberpakhtunkhwa

City：

Nowshera

单位(医院)：

 District headquarter hospital Nowshera 

单位级别：

 Community hospital 

Institution
hospital：

District headquarter hospital Nowshera

Level of the institution：

Tertiary

测量指标：

Outcomes：

指标中文名：

Liver function Profile

指标类型：

主要指标

Outcome：

Improvement in liver function profile

Type：

Primary indicator

测量时间点：

12 weeks

测量方法：

Biochemical tests

Measure time point of outcome：

24 weeks

Measure method：

指标中文名：

Lipid profile

指标类型：

次要指标

Outcome：

Improvement in Lipid profile

Type：

Secondary indicator

测量时间点：

12 weeks

测量方法：

Biochemical tests

Measure time point of outcome：

24 weeks

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

nil

组织：

nil

Sample Name：

nil

Tissue：

nil

人体标本去向

 使用后销毁  

说明

nil

Fate of sample：

Destruction after use  

Note：

nil

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 20 岁 years
最大 Max age 70 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

Computer generated randomization.

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

he participants will be randomized into three groups. The random technique will be used form a list of random numbers obtained from computer of eligible patients which will be compiled by using the patients’ hospital identification numbers.

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：

Blinded (masking used)

Blinding：

The study is double blinded nether the participant know and nether the experimenter or investigator knows.

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）：

None

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

None

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：

None

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

None

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：

  2023-12-28 11:18:10