Efficacy and Safety of QiShen YiQi Dripping Pills in the Treatment of Diabetic Kidney Disease (Syndrome of Qi Deficiency With Blood Stasis)

Diabetic Kidney Disease Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06006689
• Other study ID #: TSL-TCM-QSYQDW-DKD-?
• Status: Recruiting
• Phase: Phase 2
• Start date: September 4, 2023
• Est. completion date: September 1, 2025

Study information

• Verified date: March 2024
• Source: Tasly Pharmaceutical Group Co., Ltd
• Contact: Rui Liu
• Phone: 022-86343626
• Email: liurui2[@]tasly.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 228
• Est. completion date: September 1, 2025
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 ß-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

Related Conditions & MeSH terms

• Diabetic Kidney Disease
• Diabetic Nephropathies
• Kidney Diseases

Intervention

Drug:
• 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

Locations

Country	Name	City	State
China	Dongzhimen Hospital of Beijing University of Chinese Medicine	Beijing	Beijing
China	Xiyuan Hospital of China Academy of Chinese Medical Sciences	Beijing	Beijing
China	The First Hospital of Hunan University of Chinese Medicine	Changsha	Hunan
China	West China Hospital of Sichuan University	Chengdu	Sichuan
China	The Affiliated TCM Hospital of Guangzhou Medical University	Guangzhou	Guangdong
China	Heilongjiang Academy of Traditional Chinese Medicine (Heilongjiang Provincial Hospital of Traditional Chinese Medicine)	Ha'erbin	Heilongjiang
China	Hangzhou hospital of traditional Chinese medicine	Hangzhou	Zhejiang
China	The Second Affiliated Hospital Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Kaifeng Hospital of Traditional Chinese Medicine	Kaifeng	Henan
China	Luoyang Third People's Hospital	Luoyang	Henan
China	Sanmenxia Central Hospital	Sanmenxia	Henan
China	Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine	Shanghai	Shanghai
China	Shanghai Sixth People's Hospital	Shanghai	Shanghai
China	Hebei Province Hospital of Traditional Chinese Medicine	Shijiazhuang	Hebei
China	First Teaching Hospital of Tianjin University of Traditional Chinese Medicine	Tianjin	Tianjin
China	Shananxi Province Hospital of Traditional Chinese Medicine	Xi'an	Shananxi

Sponsors (1)

Lead Sponsor	Collaborator
Tasly Pharmaceutical Group Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in ß2-MG.	Change in ß2-MG from baseline to weeks 4, 8 and 12.	Baseline to weeks 4, 8 and 12
Other	Change in Cys-C.	Change in Cys-C from baseline to weeks 4, 8 and 12.	Baseline to weeks 4, 8 and 12
Other	Change in PCX.	Change in PCX from baseline to week 12.	Baseline to week 12
Other	Change in MCP-1.	Change in MCP-1 from baseline to week 12.	Baseline to week 12
Primary	Change in UACR(urinary albumin ? to ? creatinine ratio).	Change in UACR from baseline to weeks 4, 8 and 12.	Baseline to weeks 4, 8 and 12
Secondary	Ratio of subjects with UACR returned to normal.	Ratio of subjects with UACR returned to normal at weeks 4, 8 and 12.	Baseline to weeks 4, 8 and 12
Secondary	Ratio of subjects with UACR decrease of more than 30% from baseline.	Ratio of subjects with UACR decrease of more than 30% from baseline at weeks 4, 8 and 12.	Baseline to weeks 4, 8 and 12
Secondary	Ratio of subjects from microalbuminuria stage to macroalbuminuria	Ratio of subjects from microalbuminuria stage to macroalbuminuria at weeks 4, 8 and 12.	Baseline to weeks 4, 8 and 12
Secondary	Change in eGFR(estimated glomerular filtration rate).	Change in eGFR from baseline to weeks 4, 8 and 12.	Baseline to weeks 4, 8 and 12
Secondary	Change in Traditional Chinese Medicine Syndrome Score	Change in Traditional Chinese Medicine Syndrome Score from baseline to weeks 4, 8 and 12. There were 9 clinical primary symptoms, 7 clinical secondary symptoms, tongue picture and pulse condition evaluated as TCM symptoms, which was defined as TCM syndrome score. The standard of TCM primary symptoms and secondary symptoms scored as without 0, light 2, medium 4, heavy 6 points. Tongue picture and pulse condition did not count.	Baseline to weeks 4, 8 and 12
Secondary	TCM syndrome	Number and ratio of subjects with Clinical recovery, obvious effect, effective or ineffective in curative effect of TCM syndrome at weeks 4, 8 and 12.	Baseline to weeks 4, 8 and 12