Using QiShen YiQi Dripping Pills to treat diabetic kidney disease
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)
This study tests if QiShen YiQi Dripping Pills can improve kidney function and overall health in people with diabetic kidney disease and type 2 diabetes.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 228 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Tasly Pharmaceutical Group Co., Ltd Industry-sponsored |
| Locations | 16 sites (Beijing, Beijing and 15 other locations) |
| Trial ID | NCT06006689 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy and safety of QiShen YiQi Dripping Pills in patients with diabetic kidney disease characterized by Qi deficiency and blood stasis. Participants will receive either a placebo or varying doses of the treatment over a specified period. The study aims to determine how well this traditional Chinese medicine can improve kidney function and overall health in individuals with type 2 diabetes. The trial will include a range of assessments to monitor patient responses and side effects.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with type 2 diabetes and a clinical diagnosis of diabetic kidney disease.
Not a fit: Patients with type 1 diabetes or those experiencing acute complications of diabetes may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new therapeutic option for managing diabetic kidney disease.
How similar studies have performed: While this approach is based on traditional Chinese medicine, similar studies have shown promise in treating chronic conditions, though this specific treatment's efficacy is still being evaluated.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Beijing, Beijing and 15 other locations
- Dongzhimen Hospital of Beijing University of Chinese Medicine — Beijing, Beijing, China (Recruiting)
- Xiyuan Hospital of China Academy of Chinese Medical Sciences — Beijing, Beijing, 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) — Ha'erbin, 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, China (Recruiting)
- Shanghai Sixth People's Hospital — Shanghai, Shanghai, China (Recruiting)
- West China Hospital of Sichuan University — Chengdu, Sichuan, China (Recruiting)
- First Teaching Hospital of Tianjin University of Traditional Chinese Medicine — Tianjin, Tianjin, 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)
Study contacts
- Study coordinator: Rui Liu
- Email: liurui2@tasly.com
- Phone: 022-86343626
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.