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Clinical study on Chinese medicine intervention in diabetes

Registration number：

ITMCTR2024000647

Date of Last Refreshed on：

2024-11-03

Date of Registration：

2024-11-03

Registration Status：

Retrospective registration

Public title：

Clinical study on Chinese medicine intervention in diabetes

English Acronym：

Scientific title：

Clinical study on Chinese medicine intervention in diabetes

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Lingfeng Qiu

Study leader：

Junfen Fu

Applicant telephone：

+86 173 0098 6692

Study leader's telephone：

+86 137 7745 7849

Applicant Fax：

Study leader's fax：

Applicant E-mail：

1785410079@qq.com

Study leader's E-mail：

fjf68@qq.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

3333 Binsheng Road Binjiang District Hangzhou Zhejiang China

Study leader's address：

3333 Binsheng Road Binjiang District Hangzhou Zhejiang China

Applicant postcode：

Study leader's postcode：

Applicant's institution：

The Children's Hospital Zhejiang University School of Medicine

Approved by ethic committee：

Approved No. of ethic committee：

2024-IRB-0194-P-01

Approved file of Ethical Committee：

View

Name of the ethic committee：

The Ethics Committee of Children's Hospital Zhejiang University School of Medicin

Date of approved by ethic committee：

2024/8/29 0:00:00

Contact Name of the ethic committee：

Ma Aimei

Contact Address of the ethic committee：

3333 Binsheng Road Binjiang District Hangzhou Zhejiang China

Contact phone of the ethic committee：

+86 571 8667 0072

Contact email of the ethic committee：

zuchiec@163.com

Primary sponsor：

Children's Hospital Zhejiang University School of Medicine National Clinical Research

Primary sponsor's address：

3333 Binsheng Road Binjiang District Hangzhou Zhejiang China

Secondary sponsor：

Country：

China

Province：

Zhejiang

City：

Hangzhou

Institution
hospital：

Children's Hospital Zhejiang University School of Medicine National Clinical Research

Address：

3333 Binsheng Road Binjiang District Hangzhou Zhejiang China

Source(s) of funding：

National Key R&D Program [2021YFC2701901]National Key R&D Program [2021YFC2701903]

Target disease：

diabetes

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Others

Objectives of Study：

To explore the effectiveness of traditional Chinese medicine in improving blood glucose levels and insulin resistance in obese people with pre-diabetes or newly diagnosed diabetes based on a multicenter randomized controlled trial.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

(1) Over 8 years old (2) Obesity: BMI≥ P95 of the BMI of the same age and sex or waist circumference ≥ P95 of the waist circumference of the same age and sex. (3) Patients with pre-diabetes or first diagnosed diabetes who have not taken medication: 1. According to the American Diabetes Association (ADA) guidelines meeting the diagnostic criteria for prediabetes means meeting one or more of the following conditions: a)5.6 mmol/L ≤ fasting blood glucose ≤ 6.9 mmol/L; b)7.8mmol/L ≤ OGTT 2 hours blood glucose ≤ 11.0 mmol/L; c)5.7% ≤ Hemoglobin A1C (HbA1C) ≤ 6.4%x 2. First diagnosis of diabetes: diabetes has just been diagnosed and has not been treated with drugs

Exclusion criteria：

1) Clinically used drugs (such as metformin etc.); 2) With moderate to severe complications; 3) Infectious disease (active stage) or receiving medication for acute disease; 4) People who can't cooperate

Study execute time：

From 2024-08-30

To      2026-12-31

Recruiting time：

From 2024-09-13

To      2024-12-31

Interventions：

60

Group：

Buried wire- spleen deficiency wet group

Sample size：

Intervention：

The corresponding acupoint buried wire

Intervention code：

60

Group：

Traditional Chinese medicine - spleen deficiency wet group

Sample size：

Intervention：

The corresponding Chinese medicine intervention

Intervention code：

60

Group：

Traditional Chinese medicine - control group

Sample size：

Intervention：

no-intervention

Intervention code：

60

Group：

Buried wire - Stomach heat dampness group

Sample size：

Intervention：

The corresponding acupoint buried wire

Intervention code：

60

Group：

Buried wire - control group

Sample size：

Intervention：

no-intervention

Intervention code：

60

Group：

Traditional Chinese medicine - Stomach heat dampness group

Sample size：

Intervention：

The corresponding Chinese medicine intervention

Intervention code：

Total sample size ： 360

Countries of recruitment
and research settings：

Country：

China

Province：

Zhejiang

City：

Hangzhou

Institution/hospital：

Hangzhou First People's Hospital

Level of the institution：

Tertiary A

Country：

China

Province：

Zhejiang

City：

Hangzhou

Institution/hospital：

Children's Hospital Zhejiang University School of Medicine National Clinical Research

Level of the institution：

Tertiary A

Country：

China

Province：

Zhejiang

City：

Hangzhou

Institution/hospital：

The First Affiliated Hospital of Zhejiang University of Traditional Chinese Medicine

Level of the institution：

Tertiary A

Outcomes：

Outcome：

Fasting insulin

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Fasting blood glucose

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

blood glucose at OGTT 2 hours

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Insulin resistance index

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

HbA1c

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

urine

Tissue：

Fate of sample 

Destruction after use

Note：

Sample Name：

faeces

Tissue：

Fate of sample 

Destruction after use

Note：

Sample Name：

blood

Tissue：

Fate of sample 

Destruction after use

Note：

Recruiting

8
Min age years
60
Max age years

Recruiting status：

Participant age：

Gender：

Both

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

Random number method

Blinding：

none

IPD sharing：

Yes

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

2027.06.30 ResMan (www.medresman.org.cn)

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

CRF

Data Managemen Committee：

Not yet

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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