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A randomized partially double-blind controlled multicenter clinical study of Gegen Qinlian Modified granules combined with irbesartan in the treatment of damp-heat type 2 diabetic nephropathy

Registration number：

ITMCTR2024000601

Date of Last Refreshed on：

2024-10-23

Date of Registration：

2024-10-23

Registration Status：

Prospective registration

Public title：

A randomized partially double-blind controlled multicenter clinical study of Gegen Qinlian Modified granules combined with irbesartan in the treatment of damp-heat type 2 diabetic nephropathy

English Acronym：

Scientific title：

A randomized partially double-blind controlled multicenter clinical study of Gegen Qinlian Modified granules combined with irbesartan in the treatment of damp-heat type 2 diabetic nephropathy

Scientific title acronym：

Study subject ID：

CXZH202308

The registration number of the Partner Registry or other register：

Applicant：

FAN YANG

Study leader：

XIAOFENG GU

Applicant telephone：

13013683212

Study leader's telephone：

0510-85108060

Applicant Fax：

Study leader's fax：

Applicant E-mail：

2895646478@qq.com

Study leader's E-mail：

Wxszyyy@163.com

Study leader's website(voluntary supply)：

https://www.wxtcm.com

Study leader's website
(voluntary supply)：

https://www.wxtcm.com

Applicant address：

No. 8 Zhongnan West Road Wuxi City

Study leader's address：

No. 8 Zhongnan West Road Wuxi City

Applicant postcode：

214071

Study leader's postcode：

214071

Applicant's institution：

Wuxi Traditional Chinese Medicine Hospital affliated to Nanjing University of Chinese Medicine

Approved by ethic committee：

Approved No. of ethic committee：

2024(研)-101-01

Approved file of Ethical Committee：

View

Name of the ethic committee：

IRB of Wuxi Hospital of Traditional Chinese Medicine

Date of approved by ethic committee：

2024/9/19 0:00:00

Contact Name of the ethic committee：

YANJU SHEN

Contact Address of the ethic committee：

No. 8 Zhongnan West Road Wuxi City

Contact phone of the ethic committee：

0510-82703775

Contact email of the ethic committee：

wxtcmirb@163.com

Primary sponsor：

Wuxi Traditional Chinese Medicine Hospital affliated to Nanjing University of Chinese Medicine

Primary sponsor's address：

Wuxi Traditional Chinese Medicine Hospital affliated to Nanjing University of Chinese Medicine

Secondary sponsor：

Country：

China

Province：

Jiangsu Province

City：

Wuxi

Institution
hospital：

Wuxi Traditional Chinese Medicine Hospital affliated to Nanjing University of Chinese Medicine

Address：

No. 8 Zhongnan West Road Wuxi City

Source(s) of funding：

Supported by China Science and Technology Development Center for Chinese Medicine

Target disease：

diabetic kidney disease(DKD)

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Others

Objectives of Study：

Verify the intervention effect of GQ formula granules on damp-heat type 2 DKD and comprehensively evaluate its safety. Compare the efficacy differences between GQ formula granules and traditional decoctions in the treatment of damp-heat type 2 DKD. Evaluate whether the efficacy of GQ formula granules in treating damp-heat type 2 DKD shows a dose-effect relationship and provide a scientific basis for determining the optimal therapeutic dose.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

(1) Meeting the western medical diagnostic criteria for diabetic nephropathy. (2) Aged between 18 and 70 years old regardless of gender. (3) Blood pressure ≤ 160/95 mmHg. (4) Fasting blood glucose (FPG) ≤ 14 mmol/L and glycosylated hemoglobin (HbA1c) ≤ 8%. (5) Creatinine clearance rate is 30 - 59 ml/min or 24-hour urine protein quantification (24hUPro) is 0.15 - 3.49 g/24h. (6) Signing the informed consent form voluntarily participating in the trial and being able to take medicine and undergo examinations as agreed.

Exclusion criteria：

(1) Those with other types of diabetes except type 2 diabetes and those who have had acute complications such as diabetic ketoacidosis and hyperglycemic hyperosmolar coma recently. (2) Pregnant or lactating women. (3) Those with proteinuria caused by other diseases such as chronic glomerulonephritis IgA nephropathy and membranous nephropathy. (4) Those with malignant tumors severe infections those with cardiac and pulmonary insufficiency and those who have received hemodialysis and after kidney transplantation. (5) Those with abnormal liver function more than three times higher than the normal value. (6) Patients with a history of alcohol and drug abuse and those with mental disorders. (7) Those with contraindications to drug use or allergic to drugs. (8) Those who have had obvious renal function damage caused by daily oral drugs. (9) Those who have used ACEI and ARB drugs within nearly 4 weeks. (10) Those who have started using SGLT2i GLP-1RA and MRA drugs within nearly 4 weeks. (11) Those who participate in other clinical trials during the treatment period.

Study execute time：

From 2024-03-01

To      2025-05-31

Recruiting time：

From 2024-10-25

To      2025-05-31

Interventions：

30

Group：

GQ decoction group (group D)

Sample size：

Intervention：

Lifestyle interventions+Irbesartan（Basic treatment）+GQ decoction

Intervention code：

30

Group：

Conventional dose GQ formula granule group (group M)

Sample size：

Intervention：

Lifestyle interventions+Irbesartan（Basic treatment）+Conventional dose GQ formula granule

Intervention code：

30

Group：

GQ formula granule simulator group (group P)

Sample size：

Intervention：

Lifestyle interventions+Irbesartan（Basic treatment）+GQ formula granule simulator

Intervention code：

30

Group：

Low-dose GQ formula granule group (group L)

Sample size：

Intervention：

Lifestyle interventions+Irbesartan（Basic treatment）+Low-dose GQ formula

Intervention code：

Total sample size ： 120

Countries of recruitment
and research settings：

Country：

China

Province：

Jiangsu Province

City：

Wuxi

Institution/hospital：

Yixing Traditional Chinese Medicine Hospital

Level of the institution：

Tertiary A

Country：

China

Province：

Jiangsu Province

City：

Wuxi

Institution/hospital：

Wuxi Traditional Chinese Medicine Hospital affliated to Nanjing University of Chinese Medicine

Level of the institution：

Tertiary A

Outcomes：

Outcome：

Vital signs

Type：

Additional indicator

Measure time point of outcome：

Measure method：

Outcome：

IMT

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

HbA1c

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

mALb

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

IPAQ

Type：

Additional indicator

Measure time point of outcome：

Measure method：

Outcome：

AI

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

DKD symptom score form

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Fundus examination

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

HDL

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

TG

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Cr

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

BUN

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

TC

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Physical examination

Type：

Additional indicator

Measure time point of outcome：

Measure method：

Outcome：

2hPBG

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

24hUPro

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Traditional Chinese medicine syndrome score form for DKD

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Damp heat certificate points table

Type：

Additional indicator

Measure time point of outcome：

Measure method：

Outcome：

FBG

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

LDL-C

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Diet Scale

Type：

Additional indicator

Measure time point of outcome：

Measure method：

Outcome：

UACR

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

DKD staging and grading assessment form

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

eGFR

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

CysC

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

EQ-5D-5L

Type：

Additional indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

Fecal

Tissue：

Fate of sample 

Preservation after use

Note：

Sample Name：

Urine

Tissue：

Fate of sample 

Preservation after use

Note：

Sample Name：

Blood

Tissue：

Fate of sample 

Preservation after use

Note：

Not yet recruiting

18
Min age years
70
Max age years

Recruiting status：

Participant age：

Gender：

Both

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

The stratified block randomization method is adopted. Stratification is carried out according to centers. With the help of SAS statistical software and a given seed number the Center Coding Random Number Table is generated. Firstly it is randomly divided into the GQ decoction group (group D) and the formula granule group (the ratio of the two groups is 1:3). Then the three groups in the GQ formula granule group are randomly grouped again. The conventional dose formula granule group (group M): low-dose formula granule group (group L): formula granule simulator group (group P) is 1:1:1. Subjects are enrolled according to random numbers. If the patient meets the enrollment conditions the researcher logs in to the randomization system and enters the user name and password (the user name and password are uniformly distributed to each center by the system administrator). After entering the system input patient-related information (such as name date of birth gender etc.) and the system automatically generates a random number.

Blinding：

IPD sharing：

No

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

Do not share raw data

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

Case Record Form 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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