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Clinical study on the treatment of diabetic nephropathy with Tangshen Qushi formula combined with probiotics

Registration number：

ITMCTR2024000344

Date of Last Refreshed on：

2024-09-01

Date of Registration：

2024-09-01

Registration Status：

Prospective registration

Public title：

Clinical study on the treatment of diabetic nephropathy with Tangshen Qushi formula combined with probiotics

English Acronym：

Clinical study on the treatment of diabetic nephropathy with Tangshen Qushi formula combined with probiotics

Scientific title：

Clinical study on the treatment of diabetic nephropathy with Tangshen Qushi formula combined with probiotics

Scientific title acronym：

Clinical study on the treatment of diabetic nephropathy with Tangshen Qushi formula combined with probiotics

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Junhui chen

Study leader：

Xusheng Liu

Applicant telephone：

17683994798

Study leader's telephone：

13503078703

Applicant Fax：

Study leader's fax：

Applicant E-mail：

1135432917@qq.com

Study leader's E-mail：

liuxu801@126.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

Room 16, 8/F, Training Building, Guangdong Provincial Hospital of Traditional Chinese

Study leader's address：

Room 16, 8/F, Training Building, Guangdong Provincial Hospital of Traditional Chinese

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Guangdong Provincial Hospital of Chinese Medicine

Approved by ethic committee：

Approved No. of ethic committee：

YF2024-191-01

Approved file of Ethical Committee：

View

Name of the ethic committee：

Ethics Committee of Guangdong Hospital of Traditional Chinese Medicine

Date of approved by ethic committee：

2024/6/20 0:00:00

Contact Name of the ethic committee：

Xiaoyan Li

Contact Address of the ethic committee：

Room 1912, Advanced Training Building, 111 Dade Road, Yuexiu District, Guangzhou, Guangdong, China

Contact phone of the ethic committee：

+86 20 81887233

Contact email of the ethic committee：

llbgs@gzucm.edu.cn

Primary sponsor：

Guangdong Provincial Hospital of Chinese Medicine

Primary sponsor's address：

111 Dade Road, Yuexiu District, Guangzhou, Guangdong

Secondary sponsor：

Country：

China

Province：

Guangdong

City：

Guangzhou

Institution
hospital：

Guangdong Provincial Hospital of Chinese Medicine

Address：

111 Dade Road, Yuexiu District

Source(s) of funding：

Guangzhou Municipal Science and Technology Bureau

Target disease：

Diabetic kidney disease

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Others

Objectives of Study：

Using traditional Chinese medicine Qushi formula combined with probiotics in the treatment of patients with diabetic nephropathy to provide therapeutic targets for the synergistic mechanism of probiotics combined with traditional Chinese medicine Qushi formula from the perspective of intestinal microecology

Description for medicine or protocol of treatment in detail：

Inclusion criteria

① Age 18-80 years old; ② Meet the diagnostic criteria of diabetic nephropathy; ③ Glomerular filtration rate eGFR in the range of 15-60 mL /min /1. 73 ㎡ and fluctuation range ≤ 30% in the 3 months before enrollment; ④ Voluntary informed consent. Diagnostic criteria for diabetic nephropathy: meet the diagnostic criteria for diabetes mellitus established by the American Diabetes Association in 2020, i.e., a clear history of diabetes mellitus, as well as the existence of a causal relationship with changes in urinary albumin and renal function, and the exclusion of other primary and secondary glomerular and systemic diseases, and meet one of the following conditions: (1) Random urinary albumin- to-creatinine ratio (UACR) ≥ 30 mg/g or urinary albumin excretion rate (UAER) ≥ 30 mg/24h, and repeated examinations within 3 to 6 months of UACR or UAER, with 2 out of 3 times meeting or exceeding the threshold value; other interfering factors such as infection were excluded; (2) eGFR <60 mL/min/1.73m2 for no less than 3 months; (3) Renal puncture biopsy consistent with DKD pathologic changes.

Exclusion criteria：

① taking antibiotic medication within 30 days or a probiotic product within 14 days; ② Immediate need for dialysis treatment; ③ Being treated with hormones or immunosuppressants; ④ Combination of active malignant tumors; ⑤Severe cardiac arrhythmia, severe heart failure, NYHA class III and above; ⑥. pregnant or lactating patients; ⑦. Those who are unable to cooperate, such as psychiatric patients; ⑧. patients who are participating in other clinical trials.

Study execute time：

From 2024-09-01

To      2025-09-01

Recruiting time：

From 2024-09-01

To      2025-03-01

Interventions：

30

Group：

Probiotic Group

Sample size：

Intervention：

Probiotics combined with Tangshen Qushi formula placebo plus usual care

Intervention code：

30

Group：

Western medicine conventional treatment group

Sample size：

Intervention：

Tangshen Qushi formula placebo combined with probiotics placebo pius usual care

Intervention code：

30

Group：

Tangshen Qushi formula Group

Sample size：

Intervention：

Tangshen Qushi formula combined with probiotics placebo pius usual care

Intervention code：

30

Group：

Probiotics combined with Tangshen Qushi formula Group

Sample size：

Intervention：

Probiotics combined with Tangshen Qushi formula plus usual care

Intervention code：

Total sample size ： 120

Countries of recruitment
and research settings：

Country：

China

Province：

Guangdong

City：

Guangzhou

Institution/hospital：

Guangdong Provincial Hospital of Chinese Medicine

Level of the institution：

Tertiary A

Country：

China

Province：

Guangdong

City：

Meizhou

Institution/hospital：

Meizhou Hospital of Traditional Chinese Medicine

Level of the institution：

Tertiary A

Country：

China

Province：

Guangxi

City：

Nanning

Institution/hospital：

The First Affiliated Hospital of Guangxi University of Chinese Medicine

Level of the institution：

Tertiary A

Country：

Chia

Province：

Guangdong

City：

Shenzhen

Institution/hospital：

Beijing University of Chinese Medicine Shenzhen Hospital

Level of the institution：

Tertiary A

Outcomes：

Outcome：

Liver function set (ALT, AST, albumin, globulin)

Type：

Adverse events

Measure time point of outcome：

Every 12 weeks (from baseline to end of study)

Measure method：

Outcome：

Annual eGFR slope

Type：

Primary indicator

Measure time point of outcome：

Every 12 weeks (from baseline to end of study)

Measure method：

CKD-EPI equation

Outcome：

Urinary albumin creatinine ratio

Type：

Secondary indicator

Measure time point of outcome：

Every 12 weeks (from baseline to end of study)

Measure method：

Outcome：

HbA1c%

Type：

Secondary indicator

Measure time point of outcome：

Every 12 weeks (from baseline to end of study)

Measure method：

Outcome：

Urinary protein creatinine ratio

Type：

Secondary indicator

Measure time point of outcome：

Every 12 weeks (from baseline to end of study)

Measure method：

Outcome：

Score of dampness syndrome scale of Chinese medicine

Type：

Secondary indicator

Measure time point of outcome：

Every 12 weeks (from baseline to end of study)

Measure method：

Outcome：

Serum potassium, calcium, phosphate

Type：

Adverse events

Measure time point of outcome：

Every 12 weeks (from baseline to end of study)

Measure method：

Outcome：

Renal function set (serum creatinine, blood urea nitrogen, serum uric acid, serum albumin)

Type：

Secondary indicator

Measure time point of outcome：

Every 12 weeks (from baseline to end of study)

Measure method：

Outcome：

Blood lipids profile (triglycerides, cholesterol, high- and low-density lipoprotein cholesterol)

Type：

Secondary indicator

Measure time point of outcome：

Every 12 weeks (from baseline to end of study)

Measure method：

Outcome：

The survival time of renal composite endpoint events

Type：

Secondary indicator

Measure time point of outcome：

Every 12 weeks (from baseline to end of study)

Measure method：

Collecting sample(s)
from participants：

Sample Name：

Feces

Tissue：

Fate of sample 

Destruction after use

Note：

Ten years for storage

Sample Name：

Urine

Tissue：

Fate of sample 

Destruction after use

Note：

Ten years for storage

Not yet recruiting

18
Min age years
80
Max age years

Recruiting status：

Participant age：

Gender：

Both

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

Subjects who met the criteria for natriuresis would be randomly assigned to the probiotic group, the Chinese medicine compound group, the probiotic combined with Chinese medicine compound group, and the conventional western medicine treatment group in the ratio of 1:1:1:1, with 30 patients in each group. The randomization protocol was conducted by the Key Research Office of Clinical Research Methodology in Traditional Chinese Medicine of Guangdong Provincial Hospital of Traditional Chinese Medicine, and the randomization sequences were generated by the SAS software.

Blinding：

Double-blind (hidden groups for both subjects and investigators)

IPD sharing：

No

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

N/A

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

Case Record Form and Electronic Medical Record will be used for data collection and management.

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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