Register Now
Log In
中文/English
About ITMCTR|Search Trials|About Us|News
Clinical study on Lianmei Rougui Recipe treatment for type 2 diabetes mellitus patients with the syndrome of heat in intestinal and cold in Gan

Registration number：

ITMCTR2023000031

Date of Last Refreshed on：

2023-08-22

Date of Registration：

2023-08-22

Registration Status：

Prospective registration

Public title：

Clinical study on Lianmei Rougui Recipe treatment for type 2 diabetes mellitus patients with the syndrome of heat in intestinal and cold in Gan

English Acronym：

Scientific title：

Clinical study on Lianmei Rougui Recipe treatment for type 2 diabetes mellitus patients with the syndrome of heat in intestinal and cold in Gan

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Xiachengdong

Study leader：

Xiachengdong

Applicant telephone：

13693597579

Study leader's telephone：

13693597579

Applicant Fax：

Study leader's fax：

Applicant E-mail：

xiachengdong72@163.com

Study leader's E-mail：

xiachengdong72@163.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

Department of Endocrinology, Xiyuan Hospital of China Academy of Chinese Medical Sciences. 1 Caochang , Xiyuan, 100091,Beijing ,China

Study leader's address：

Department of Endocrinology, Xiyuan Hospital of China Academy of Chinese Medical Sciences. 1 Caochang , Xiyuan, 100091,Beijing ,China

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Approved by ethic committee：

Approved No. of ethic committee：

2023XLA054-2

Approved file of Ethical Committee：

View

Name of the ethic committee：

The medical ethics committee of Xiyuan Hospital of China Academy of Chinese Medical Sciences

Date of approved by ethic committee：

2023/4/27 0:00:00

Contact Name of the ethic committee：

Zimingjie

Contact Address of the ethic committee：

Institute of Clinical Pharmacology，Xiyuan Hospital of China Academy of Chinese Medical Sciences. 1 Caochang , Xiyuan, 100091,Beijing ,China

Contact phone of the ethic committee：

01062835646

Contact email of the ethic committee：

593982598@qq.com

Primary sponsor：

Xiyuan Hospital of China Academy of Chinese Medical Sciences.

Primary sponsor's address：

Xiyuan Hospital of China Academy of Chinese Medical Sciences. 1 Caochang , Xiyuan, 100091,Beijing ,China

Secondary sponsor：

Country：

China

Province：

Beijing

City：

Haidian

Institution
hospital：

Xiyuan Hospital of China Academy of Chinese Medical Sciences.

Address：

Xiyuan Hospital of China Academy of Chinese Medical Sciences. 1 Caochang , Xiyuan, 100091,Beijing ,China

Source(s) of funding：

Unit self-raised funds

Target disease：

type 2 diabetes mellitus

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Pilot clinical trial

Objectives of Study：

In this study, metformin tablets were used as a positive drug control to carry out a randomized controlled prospective clinical study of Lianmei Rougui Recipe in the treatment of newly diagnosed patients with type 2 diabetes with the syndrome of heat in intestinal and cold in Gan. A total of 100 patients newly diagnosed type 2 diabetes mellitus with the syndrome of heat in intestinal and cold in Gan were included, and 50 cases were included in the Lianmei Rougui Recipe experimental group and the metformin control group. The experimental group used Lianmei Rougui Recipe, and the control group used metformin tablets; The course of treatment is 12 weeks. To detect blood glucose, glycated hemoglobin, blood lipids, serum insulin level, body weight, waist-hip ratio, Traditional Chinese Medicine syndrome points, and safety indicators such as blood and urine routine, liver and kidney function, electrocardiogram before and after the treatment intervention. To evaluate the efficacy and safety of Lianmei Rougui Recipe in the treatment of patients with type 2 diabetes mellitus with the syndrome of heat in intestinal and cold in Gan; In order to form a diagnosis and treatment plan for Lianmei Rougui Recipe for the treatment of type 2 diabetes patients with the syndrome of heat in intestinal and cold in Gan, innovate the pathogenesis theory of " heat in intestinal and cold in Gan" of type 2 diabetes, give full play to the characteristics of traditional Chinese medicine to diagnose and treat type 2 diabetes, and lay a clinical evidence foundation.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

Patients with type 2 diabetes mellitus who were newly diagnosed within half a year and did not receive any hypoglycemic drug treatment ; the diagnostic criteria of Traditional Chinese Medicine syndromes of intestinal heat and liver cold syndrome ; aged between 18-65 years old ; fasting plasma glucose concentration < 11.1mmol / L, and glycated hemoglobin A1c< 9.5 % ; patients were informed and voluntarily signed informed consent.

Exclusion criteria：

In the past 1 month,patients had the acute metabolic disorders such as diabetic ketoacidosis or severe infection ; patients with severe primary diseases such as liver, kidney, hematopoietic system, malignant tumor or severe mental illness ; those who did not cooperate during the introduction period ( referring to those who could not cooperate with diet and exercise control and lifestyle adjustment ) ; pregnant or lactating women ; patients participated in other clinical trials in the past 3 months ; Patients with contraindications to metformin or unsuitable for metformin.

Study execute time：

From 2023-04-01

To      2026-12-31

Recruiting time：

From 2023-09-01

To      2025-12-31

Interventions：

50

Group：

Lianmei Rougui Recipe group

Sample size：

Intervention：

Lianmei Rougui Recipe

Intervention code：

50

Group：

metformin group

Sample size：

Intervention：

metformin

Intervention code：

Total sample size ： 100

Countries of recruitment
and research settings：

Country：

China

Province：

Beijing

City：

Haidian

Institution/hospital：

Xiyuan Hospital of China Academy of Chinese Medical Sciences. 1 Caochang , Xiyuan, 100091,Beijing ,China

Level of the institution：

grade A class three hospital

Outcomes：

Outcome：

low-density lipoprotein cholesterol

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

insulin resistance index

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

fasting fingertip blood glucose

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

fingerstick blood glucose 2 hours after meals

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

high-density lipoprotein cholesterol

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

plasma glucose concentration 2 hours after meals

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

total cholesterol

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

triglycerides

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

fasting plasma glucose concentration

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

plasma insulin

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

glycated hemoglobin A1c

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

blood

Tissue：

Fate of sample 

Destruction after use

Note：

Not yet recruiting

18
Min age years
65
Max age years

Recruiting status：

Participant age：

Gender：

Both

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

The biostatistician who had nothing to do with the data management and statistical analysis of this experiment, would use SAS 8.0 statistical software package on the computer to obtain the randomized codes; The experimental group and the control group would be randomly coded according to the ratio of 1 : 1.

Blinding：

IPD sharing：

No

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

In December 2026, the conclusion report of the study.

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

Case Record Form

Data Managemen Committee：

Yes

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

back
Platform information
About ITMCTR
About Us
Register Trials
Frequently Asked Questions
Ethical Review
The public service
Search Trials
Join Us
ITMCTR BJ-ICP:07032215-5 Tip: IE8 is recommended Use the system with widescreen display resolution above