Efficacy and Safety of QiShen YiQi Dripping Pills in the Treatment of Diabetic Kidney Disease (Syndrome of Qi Deficiency With Blood Stasis)
NCT ID: NCT06006689
Last Updated: 2024-03-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
228 participants
INTERVENTIONAL
2023-09-04
2025-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo group
Qishen Yiqi Dripping Pills placebo, 3 bags, take orally after meals, 3 times a day
Qishen Yiqi Dripping Pills placebo 3 bags
Qishen Yiqi Dripping Pills placebo contain Qishen Yiqi dripping pills placebo 3 bags(0.52g dripping pills placebo per bag),take orally after meals, 3 times a day for 12weeks
Low dose group
Low dose Qishen Yiqi Dripping Pills, 3 bags, take orally after meals, 3 times a day
Low dose Qishen Yiqi Dripping Pills 3 bags
Low dose Qishen Yiqi Dripping Pills contain Qishen Yiqi dripping pills 2 bags(0.52g dripping pills per bag) and Qishen Yiqi dripping pills placebo 1 bag(0.52g dripping pills placebo per bag),take orally after meals, 3 times a day for 12weeks
High dose group
High dose Qishen Yiqi Dripping Pills, 3 bags, take orally after meals, 3 times a day
High dose Qishen Yiqi Dripping Pills 3 bags
High dose Qishen Yiqi Dripping Pills contain Qishen Yiqi dripping pills 3 bags(0.52g dripping pills per bag),take orally after meals, 3 times a day for 12weeks
Interventions
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Qishen Yiqi Dripping Pills placebo 3 bags
Qishen Yiqi Dripping Pills placebo contain Qishen Yiqi dripping pills placebo 3 bags(0.52g dripping pills placebo per bag),take orally after meals, 3 times a day for 12weeks
Low dose Qishen Yiqi Dripping Pills 3 bags
Low dose Qishen Yiqi Dripping Pills contain Qishen Yiqi dripping pills 2 bags(0.52g dripping pills per bag) and Qishen Yiqi dripping pills placebo 1 bag(0.52g dripping pills placebo per bag),take orally after meals, 3 times a day for 12weeks
High dose Qishen Yiqi Dripping Pills 3 bags
High dose Qishen Yiqi Dripping Pills contain Qishen Yiqi dripping pills 3 bags(0.52g dripping pills per bag),take orally after meals, 3 times a day for 12weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Tasly Pharmaceutical Group Co., Ltd
INDUSTRY
Responsible Party
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Locations
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Dongzhimen Hospital of Beijing University of Chinese Medicine
Beijing, Beijing Municipality, China
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, China
The Affiliated TCM Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Hebei Province Hospital of Traditional Chinese Medicine
Shijiazhuang, Hebei, China
Heilongjiang Academy of Traditional Chinese Medicine (Heilongjiang Provincial Hospital of Traditional Chinese Medicine)
Harbin, Heilongjiang, China
Kaifeng Hospital of Traditional Chinese Medicine
Kaifeng, Henan, China
Luoyang Third People's Hospital
Luoyang, Henan, China
Sanmenxia Central Hospital
Sanmenxia, Henan, China
The First Hospital of Hunan University of Chinese Medicine
Changsha, Hunan, China
Shananxi Province Hospital of Traditional Chinese Medicine
Xi'an, Shananxi, China
Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, China
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin Municipality, China
Hangzhou hospital of traditional Chinese medicine
Hangzhou, Zhejiang, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TSL-TCM-QSYQDW-DKD-Ⅱ
Identifier Type: -
Identifier Source: org_study_id
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