Clinical trial NCT06006689: Efficacy and Safety of QiShen YiQi Dripping Pills in the Treatment of Diabetic Kidney Disease (Syndrome of Qi Deficiency With Blood Stasis)
Official title: A Randomized, Double-blind, Multi-center, Standardise-loaded, Placebo-parallel Controlled Clinical Trial of Efficacy and Safety of QiShen YiQi Dripping Pills in the Treatment of Diabetic Kidney Disease (Syndrome of Qi Deficiency With Blood Stasis)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Diabetic Kidney Disease
Lead sponsor: Tasly Pharmaceutical Group Co., Ltd
Sponsor class: INDUSTRY
First posted: 2023-08-23
Enrollment: 228
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy and Safety of QiShen YiQi Dripping Pills in the treatment of Diabetic Kidney Disease (syndrome of Qi deficiency with blood stasis)


Eligibility criteria: Inclusion Criteria:

* Man or woman between 18-75 years-old
* Subjects with type 2 diabetes mellitus
* Subjects with a clinical diagnosis of diabetic kidney disease
* eGFR≥ 45 mL/min/1.73 m2
* UACR ≥ 30 mg/g but ≤ 300 mg/g
* Conformed to the TCM syndrome differentiation standard of chronic heart failure syndrome of Qi deficiency and blood stasis
* Received Steady dose of ACEI or ARB therapy for chronic heart failure at least 2 weeks before receiving investigational drug
* Abide by the experimental protocol and cooperate with the data collection according to the researcher's judgment

Exclusion Criteria:

* Subjects with type 1 diabetes mellitus or other specific types of diabetes
* Acute complications of diabetes such as diabetic ketoacidosis and hyperosmolar hyperglycemia occurred in the past 3 months
* HbA1c ≥8.5% or fasting blood glucose \>11 mmol/L
* Urinary sediment indicates "active" glomerulogenic hematuria
* Subjects have been clinically confirmed cases of primary glomerular disease, secondary glomerular disease other than DKD or other systemic diseases
* The presence of uncontrolled hypertension, systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg or Hypotension with a systolic blood pressure \<90mmHg and/or a diastolic blood pressure \<60mmHg
* ALT or AST\> 2 times the upper limit of normal
* Serum potassium\> the upper limit of normal
* Patients with unstable basic treatment for lowering blood glucose and blood lipids within the past 3 months, and patients with unstable basic treatment for lowering blood pressure within the past 1 month (changing the type of drugs, such as changing the β-receptor blockers to calcium ion antagonists, etc.)
* Take the following medications within the last 2 weeks：a. Other drugs for the treatment of DKD (Finerenone, Keluoxin capsule, Qizhi Yishen capsule, SGLT2i drugs, GLP-1 drugs, etc.), b. Calcium oxybenzenesulfonate for the treatment of diabetic retinopathy, c. Chinese patent medicine, Chinese medicine decoction, formula granule and other Chinese medicine preparations with the same composition or function indications, d. Tripterygium wilfordii related preparations, Huangkui capsule
* Patients who need to take antiplatelet drugs, the dose was stable for less than 1 month
* Serious diseases of other systemic systems that may affect the judgment of efficacy and safety
* A history of alcohol or drug abuse with a combination of mental illness and poor control
* Allergic to the experimental drug or its ingredients
* Women who are pregnant or breastfeeding, or who have a need to have children during the trial
* Participating in other clinical studies and taking investigational drugs from other studies within 3 months prior to screening
* The investigator deems that the patient is not suitable to participate in the study

Primary outcomes:
measure: Change in UACR(urinary albumin ⁃ to ⁃ creatinine ratio).
timeFrame: Baseline to weeks 4, 8 and 12
Secondary outcomes:
measure: Ratio of subjects with UACR returned to normal.
timeFrame: Baseline to weeks 4, 8 and 12
measure: Ratio of subjects with UACR decrease of more than 30% from baseline.
timeFrame: Baseline to weeks 4, 8 and 12
measure: Ratio of subjects from microalbuminuria stage to macroalbuminuria
timeFrame: Baseline to weeks 4, 8 and 12
measure: Change in eGFR(estimated glomerular filtration rate).
timeFrame: Baseline to weeks 4, 8 and 12
measure: Change in Traditional Chinese Medicine Syndrome Score
timeFrame: Baseline to weeks 4, 8 and 12
measure: TCM syndrome
timeFrame: Baseline to weeks 4, 8 and 12
Other outcomes:
measure: Change in β2-MG.
timeFrame: Baseline to weeks 4, 8 and 12
measure: Change in Cys-C.
timeFrame: Baseline to weeks 4, 8 and 12
measure: Change in PCX.
timeFrame: Baseline to week 12
measure: Change in MCP-1.
timeFrame: Baseline to week 12
Locations:
city: Beijing
country: China
facility: Dongzhimen Hospital of Beijing University of Chinese Medicine
state: Beijing
city: Beijing
country: China
facility: Xiyuan Hospital of China Academy of Chinese Medical Sciences
state: Beijing
city: Guangzhou
country: China
facility: The Affiliated TCM Hospital of Guangzhou Medical University
state: Guangdong
city: Shijiazhuang
country: China
facility: Hebei Province Hospital of Traditional Chinese Medicine
state: Hebei
city: Ha'erbin
country: China
facility: Heilongjiang Academy of Traditional Chinese Medicine (Heilongjiang Provincial Hospital of Traditional Chinese Medicine)
state: Heilongjiang
city: Kaifeng
country: China
facility: Kaifeng Hospital of Traditional Chinese Medicine
state: Henan
city: Luoyang
country: China
facility: Luoyang Third People's Hospital
state: Henan
city: Sanmenxia
country: China
facility: Sanmenxia Central Hospital
state: Henan
city: Changsha
country: China
facility: The First Hospital of Hunan University of Chinese Medicine
state: Hunan
city: Xi'an
country: China
facility: Shananxi Province Hospital of Traditional Chinese Medicine
state: Shananxi
city: Shanghai
country: China
facility: Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Sixth People's Hospital
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
state: Tianjin
city: Hangzhou
country: China
facility: Hangzhou hospital of traditional Chinese medicine
state: Zhejiang
city: Hangzhou
country: China
facility: The Second Affiliated Hospital Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References: