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

NCT06006689 | Recruiting Phase 2

• 1 other identifier: TSL-TCM-QSYQDW-DKD-Ⅱ
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 16

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)

Conditions

Diabetic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Ratio of subjects with UACR returned to normal.

  Baseline to weeks 4, 8 and 12

• Ratio of subjects with UACR decrease of more than 30% from baseline.

  Baseline to weeks 4, 8 and 12

• Ratio of subjects from microalbuminuria stage to macroalbuminuria

  Baseline to weeks 4, 8 and 12

• Change in eGFR(estimated glomerular filtration rate).

  Baseline to weeks 4, 8 and 12

• Change in Traditional Chinese Medicine Syndrome Score

  Baseline to weeks 4, 8 and 12

Other Outcomes (4)

• Change in β2-MG.

  Baseline to weeks 4, 8 and 12

• Change in Cys-C.

  Baseline to weeks 4, 8 and 12

• Change in PCX.

  Baseline to week 12

Study Arms (3)

Placebo group

PLACEBO COMPARATOR

Qishen Yiqi Dripping Pills placebo, 3 bags, take orally after meals, 3 times a day

Drug: Qishen Yiqi Dripping Pills placebo 3 bags

Low dose group

EXPERIMENTAL

Low dose Qishen Yiqi Dripping Pills, 3 bags, take orally after meals, 3 times a day

Drug: Low dose Qishen Yiqi Dripping Pills 3 bags

High dose group

EXPERIMENTAL

High dose Qishen Yiqi Dripping Pills, 3 bags, take orally after meals, 3 times a day

Drug: High dose Qishen Yiqi Dripping Pills 3 bags

Interventions

Qishen Yiqi Dripping Pills placebo 3 bags DRUG

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

Also known as: Placebo group

Placebo group

Low dose Qishen Yiqi Dripping Pills 3 bags DRUG

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

Also known as: Low dose group

Low dose group

High dose Qishen Yiqi Dripping Pills 3 bags DRUG

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

Also known as: High dose group

High dose group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tasly Pharmaceutical Group Co., Ltd: lead

Study Sites (16)

Dongzhimen Hospital of Beijing University of Chinese Medicine

Beijing, Beijing Municipality, China

RECRUITING

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, China

RECRUITING

The Affiliated TCM Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

RECRUITING

Hebei Province Hospital of Traditional Chinese Medicine

Shijiazhuang, Hebei, China

RECRUITING

Heilongjiang Academy of Traditional Chinese Medicine (Heilongjiang Provincial Hospital of Traditional Chinese Medicine)

Harbin, Heilongjiang, China

RECRUITING

Kaifeng Hospital of Traditional Chinese Medicine

Kaifeng, Henan, China

RECRUITING

Luoyang Third People's Hospital

Luoyang, Henan, China

RECRUITING

Sanmenxia Central Hospital

Sanmenxia, Henan, China

RECRUITING

The First Hospital of Hunan University of Chinese Medicine

Changsha, Hunan, China

RECRUITING

Shananxi Province Hospital of Traditional Chinese Medicine

Xi'an, Shananxi, China

RECRUITING

Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, China

RECRUITING

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

West China Hospital of Sichuan University

Chengdu, Sichuan, China

RECRUITING

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Tianjin, Tianjin Municipality, China

RECRUITING

Hangzhou hospital of traditional Chinese medicine

Hangzhou, Zhejiang, China

RECRUITING

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Diabetic Nephropathies

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Central Study Contacts

Rui Liu

CONTACT

022-86343626; liurui2@tasly.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2023
• First Posted: August 23, 2023
• Study Start: September 4, 2023
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: March 13, 2024

Record last verified: 2024-03

Locations

CN (16)