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Efficacy and safety of Keluoxin capsule combined with SGLT2 inhibitor in the treatment of diabetic nephropathy

Registration number：

ITMCTR2024000586

Date of Last Refreshed on：

2024-10-21

Date of Registration：

2024-10-21

Registration Status：

Prospective registration

Public title：

Efficacy and safety of Keluoxin capsule combined with SGLT2 inhibitor in the treatment of diabetic nephropathy

English Acronym：

Scientific title：

Efficacy and safety of Keluoxin capsule combined with SGLT2 inhibitor in the treatment of diabetic nephropathy

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Yin Jingxia

Study leader：

Yin Jingxia

Applicant telephone：

13527349863

Study leader's telephone：

13527349863

Applicant Fax：

Study leader's fax：

Applicant E-mail：

906802276@qq.com

Study leader's E-mail：

906802276@qq.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

90 Weiguo Road, Danzishi, Nan'an District, Chongqing, China

Study leader's address：

90 Weiguo Road, Danzishi, Nan'an District, Chongqing, China

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Armed Police Hospital of Chongqing

Approved by ethic committee：

Approved No. of ethic committee：

(2024)伦理临审第(WJ-240104)号

Approved file of Ethical Committee：

View

Name of the ethic committee：

Ethics Committee of Armed Police Hospital of Chongqing

Date of approved by ethic committee：

2024/7/27 0:00:00

Contact Name of the ethic committee：

Wang Juan

Contact Address of the ethic committee：

90 Weiguo Road, Danzishi, Nan'an District, Chongqing, China

Contact phone of the ethic committee：

17365293920

Contact email of the ethic committee：

17720870@qq.com

Primary sponsor：

Armed Police Hospital of Chongqing

Primary sponsor's address：

90 Weiguo Road, Danzishi, Nan'an District, Chongqing, China

Secondary sponsor：

Country：

China

Province：

Chongqing

City：

Nan'an District

Institution
hospital：

Armed Police Hospital of Chongqing

Address：

90 Weiguo Road, Danzishi, Nan'an District, Chongqing, China

Source(s) of funding：

Traditional Chinese Medicine Research Project of Chongqing City Health Commission

Target disease：

Type 2 diabetic nephropathy

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Post-marketing clinical trial

Objectives of Study：

1. To understand the efficacy of Keluoxin Capsule combined with SGLT2i in treating patients with DKD with deficiency of both qi and yin and blood stasis syndrome, and to evaluate the outcome of patients with different renal functions and different urinary microprotein levels after treatment, so as to find the best suitable group for this integrated traditional Chinese and Western medicine treatment. 2. By evaluating the impact of this treatment on the underlying disease state (blood pressure, blood sugar, blood lipids), insulin resistance, and blood uric acid, we will evaluate whether this integrated traditional Chinese and Western medicine treatment method can play an important role in the high-risk factors of the progression of DKD, and help its clinical efficacy. Make an objective evaluation. 3. By monitoring adverse reactions such as liver function, urogenital infections, hypoglycemia, and diarrhea, we can understand the safety of long-term medication and help patients improve treatment compliance.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

1. Patients who have been diagnosed with T2DM according to the 1999 WHO diagnostic criteria; 2. Patients with diabetic nephropathy diagnosed according to the diagnostic criteria recommended in the 2021 "Chinese Guidelines for the Prevention and Treatment of Diabetic Kidney Disease"; that is, UACR≥30 mg/g at least twice within 3 months, excluding interfering factors; 3. The estimated glomerular filtration rate (eGFR) is between 30 and 90mL/min/1.73m2. 4. According to the syndrome differentiation and classification standards for the treatment of diabetes in the "Guiding Principles for Clinical Research of New Traditional Chinese Medicine (Trial)" and the diagnostic standards for blood stasis syndrome formulated by the Chinese Society of Integrated Traditional Chinese and Western Medicine, those who meet the syndrome of deficiency of both qi and yin and blood stasis; 5. Have received stable maximum tolerated doses of ACEi/ARB for ≥4 weeks.

Exclusion criteria：

1. Patients with non-deficiency of both qi and yin combined with blood stasis syndrome or patients with nephropathy caused by other types of diabetes; 2. Pregnant and nursing women; 3. Acute complications of severe diabetes; 4. Patients with severe liver dysfunction; 5. Acute attack period of severe cardiovascular and cerebrovascular diseases; 6. Have used or are using other proprietary Chinese medicines with renal-protecting effects SGLT2i drugs and other drugs that have an impact on renal function within the previous 3 months; 7. In the opinion of the investigator there are any other circumstances that may prevent the subject from completing the study or pose significant risks to the subject.

Study execute time：

From 2024-11-01

To      2026-05-31

Recruiting time：

From 2024-11-01

To      2025-11-30

Interventions：

98

Group：

SGLT2i combined with Keloxin capsule treatment group

Sample size：

Intervention：

Taking Keloxin capsules and SGLT2i drugs with evidence of renal protection

Intervention code：

98

Group：

SGLT2i treatment group

Sample size：

Intervention：

Taking SGLT2i drugs empagliflozin tablets or dapagliflozin tablets with evidence of renal protection

Intervention code：

98

Group：

Keluoxin Capsule treatment group

Sample size：

Intervention：

Take Keloxin Capsules

Intervention code：

Total sample size ： 294

Countries of recruitment
and research settings：

Country：

China

Province：

Chongqing

City：

Nan'an District

Institution/hospital：

Armed Police Hospital of Chongqing

Level of the institution：

tertiary hospitals

Outcomes：

Outcome：

TCM symptom points

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

weight

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

waist-hip ratio

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

adverse event rates

Type：

Adverse events

Measure time point of outcome：

Measure method：

Outcome：

body mass index

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

blood glucose

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

waist height ratio

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

serum uric acid

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

blood lipid

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

islet function

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

blood pressure

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Kidney disease progression rate

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Effective treatment of kidney disease

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Determine blood creatinine levels

Outcome：

Delayed or reversed kidney disease rate

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Determination of urinary microalbumin content

Collecting sample(s)
from participants：

Sample Name：

blood

Tissue：

Fate of sample 

Destruction after use

Note：

Sample Name：

urine

Tissue：

Fate of sample 

Destruction after use

Note：

Not yet recruiting

18
Min age years
90
Max age years

Recruiting status：

Participant age：

Gender：

Both

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

Statistical experts from the Department of Epidemiology and Health Statistics of the Army Medical University participated in the study and were randomized according to the randomization principle of random number table method. Random work was completed by persons not associated with the study.

Blinding：

IPD sharing：

No

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

No

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

NO

Data Managemen Committee：

Yes

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

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