Real world study on the efficacy and safety of Shenqi Jiangtang tablets in the treatment of type 2 diabetes mellitus

Registration number:

ITMCTR2100004820

Date of Last Refreshed on:

2021-03-23

Date of Registration:

2021-03-23

Registration Status:

Prospective registration

Public title:

Real world study on the efficacy and safety of Shenqi Jiangtang tablets in the treatment of type 2 diabetes mellitus

English Acronym:

Scientific title:

Real world study on the efficacy and safety of Shenqi Jiangtang tablets in the treatment of type 2 diabetes mellitus

Scientific title acronym:

Study subject ID:

The registration number of the Partner Registry or other register:

ChiCTR2100044493 ; ChiMCTR2100004820

Applicant:

Liangjun Hu

Study leader:

Enfeng Song, Ling Gao

Applicant telephone:

+86 15827639709

Study leader's telephone:

+86 15307143917, +86 15927469449

Applicant Fax:

Study leader's fax:

Applicant E-mail:

16765084@qq.com

Study leader's E-mail:

16765084@qq.com

Study leader's website(voluntary supply):

Study leader's website
(voluntary supply):

Applicant address:

Office 4018, New World International Trade Building, 586 Jianshe Avenue, Jianghan District, Wuhan, Hubei

Study leader's address:

99 Zhangzhidong Road (formerly Ziyang Road), 238 Jiefang Road, Wuchang District, Wuhan, Hubei

Applicant postcode:

Study leader's postcode:

Applicant's institution:

Schwitt (Wuhan) Medical Technology Co., Ltd

Approved by ethic committee:

Approved No. of ethic committee:

ChiECRCT20210109

Approved file of Ethical Committee:

View

Name of the ethic committee:

Chinese Ethics Committee of Registering Clinical TRials

Date of approved by ethic committee:

2021/4/24 0:00:00

Contact Name of the ethic committee:

Wu Chun

Contact Address of the ethic committee:

Chinese Clinical trial Hong Kong Centre, Baptist University Road, Kowloon Tong, Hong Kong SAR, China

Contact phone of the ethic committee:

+86 18980604562

Contact email of the ethic committee:

chictr001@chictr.org.cn

Primary sponsor:

People's Hospital of Wuhan University

Primary sponsor's address:

99 Zhangzhidong Road (formerly Ziyang Road), 238 Jiefang Road, Wuchang District, Wuhan, Hubei

Secondary sponsor:

Country:

China

Province:

Guangdong

City:

Shantou

Institution
hospital:

Guangdong Wanqing Pharmaceutical Co., Ltd

Address:

No.08, Area 16, Chaoyang Road, Jinyuan Industrial City

Source(s) of funding:

raise independently

Target disease:

Type 2 diabetes

Target disease code:

Study type:

Observational study

Study design:

Sequential

Study phase:

Post-marketing clinical trial

Objectives of Study:

Taking fasting blood glucose, HbA1c as the main indexes, to explore the efficacy and safety of Shenqi Jiangtang tablets combined with conventional standard treatment of Western medicine in the treatment of type 2 diabetes.

Description for medicine or protocol of treatment in detail:

In this clinical trial, patients with type 2 diabetes mellitus were selected as the target group. On the basis of conventional western medicine treatment, Shenqi Jiangtang Tablet was combined with intervention. The observation period was 6 months. The main indications were fasting blood glucose, HbA1c and TCM syndrome score. The efficacy of Shenqi Jiangtang Tablet on patients with diabetes mellitus was discussed, and its safety was further observed.

Inclusion criteria

1. Patients who met the diagnostic criteria of Chinese guidelines for the prevention and treatment of type 2 diabetes (2017 Edition); 2. Aged 18-75 years; 3. 7% < HbA1c <= 10%; 4. Patients agreed and signed informed consent.

Exclusion criteria:

1. Blood glucose >= 13.57mmol/l; 2. Abnormal liver and kidney function: ALT or ast > 2 x ULN or TBIL > 2 x ULN; Cr > 1 x ULN or CCR < 60ml / min; 3. Pregnant or lactating women within half a year; 4. Allergic constitution or known allergy to the drugs and their components used in this test; 5. Patients considered unsuitable by the researchers.

Study execute time:

From 2021-03-01

To      2024-02-28

Recruiting time:

From 2021-04-01

To      2023-06-01

Interventions:

5000

Group:

Observation group

Sample size:

Intervention:

Add Shenqi Jiangtang Tablet to hypoglycemic Western Medicine

Intervention code:

Total sample size : 5000

Countries of recruitment
and research settings:

Country:

China

Province:

Hubei

City:

Wuhan

Institution/hospital:

People's Hospital of Wuhan University

Level of the institution:

Tertiary A

Outcomes:

Outcome:

proportion of HbA1c<=7%

Type:

Primary indicator

Measure time point of outcome:

Measure method:

Outcome:

HbA1c

Type:

Primary indicator

Measure time point of outcome:

Measure method:

Outcome:

FPG

Type:

Primary indicator

Measure time point of outcome:

Measure method:

Collecting sample(s)
from participants:

Recruiting

18
Min age years
75
Max age years

Recruiting status:

Participant age:

Gender:

Both

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

Non-randomization.

Blinding:

N/A

IPD sharing:

Yes

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

Schwitt research cloud platform https://yun.shivictory.com/home/main October 30th, 2024

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

Schwitt research cloud platform (EDC)

Data Managemen Committee:

Not yet

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