Diabetic Kidney DiseasePhase 2NCT06006689
Efficacy and Safety of QiShen YiQi Dripping Pills in the Treatment of Diabetic Kidney Disease (Syndrome of Qi Deficiency With Blood Stasis)
A Phase 2 study testing Low dose Qishen Yiqi Dripping Pills 3 bags and High dose Qishen Yiqi Dripping Pills 3 bags in people with Diabetic Kidney Disease, run by Tasly Pharmaceutical Group Co., Ltd at 16 sites in China.
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) Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetic Kidney Disease
- What is being tested?
- Low dose Qishen Yiqi Dripping Pills 3 bags and High dose Qishen Yiqi Dripping Pills 3 bags
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 228 participants
- Where
- 16 sitesChina
- Study dates
- 15 Sep 2023to 16 Apr 2025
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
China16 sites
Dongzhimen Hospital of Beijing University of Chinese Medicine
Beijing, Beijing Municipality
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality
The First Hospital of Hunan University of Chinese Medicine
Changsha, Hunan
West China Hospital of Sichuan University
Chengdu, Sichuan
The Affiliated TCM Hospital of Guangzhou Medical University
Guangzhou, Guangdong
Hangzhou hospital of traditional Chinese medicine
Hangzhou, Zhejiang
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang
Heilongjiang Academy of Traditional Chinese Medicine (Heilongjiang Provincial Hospital of Traditional Chinese Medicine)
Harbin, Heilongjiang
Kaifeng Hospital of Traditional Chinese Medicine
Kaifeng, Henan
Luoyang Third People's Hospital
Luoyang, Henan
Sanmenxia Central Hospital
Sanmenxia, Henan
Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality
Hebei Province Hospital of Traditional Chinese Medicine
Shijiazhuang, Hebei
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin Municipality
Shananxi Province Hospital of Traditional Chinese Medicine
Xi'an, Shananxi
About this study
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)
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
- Being tested
- Qishen Yiqi Dripping Pills placebo 3 bags, Low dose Qishen Yiqi Dripping Pills 3 bags, High dose Qishen Yiqi Dripping Pills 3 bags
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qishen Yiqi Dripping Pills placebo 3 bagsDrug
Also called Placebo group
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 bagsDrug
Also called Low dose group
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 bagsDrug
Also called High dose group
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
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Placebo comparator | Qishen Yiqi Dripping Pills placebo, 3 bags, take orally after meals, 3 times a day Receives: 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 Receives: 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 Receives: Drug: High dose Qishen Yiqi Dripping Pills 3 bags |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in UACR(urinary albumin ⁃ to ⁃ creatinine ratio).
Change in UACR from baseline to weeks 4, 8 and 12.
Measured: Baseline to weeks 4, 8 and 12
Secondary outcomes (6)
Ratio of subjects with UACR returned to normal.
Ratio of subjects with UACR returned to normal at weeks 4, 8 and 12.
Measured: Baseline to weeks 4, 8 and 12
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.
Measured: Baseline to weeks 4, 8 and 12
Ratio of subjects from microalbuminuria stage to macroalbuminuria
Ratio of subjects from microalbuminuria stage to macroalbuminuria at weeks 4, 8 and 12.
Measured: Baseline to weeks 4, 8 and 12
Change in eGFR(estimated glomerular filtration rate).
Change in eGFR from baseline to weeks 4, 8 and 12.
Measured: Baseline to weeks 4, 8 and 12
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.
Measured: Baseline to weeks 4, 8 and 12
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.
Measured: Baseline to weeks 4, 8 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start15 Sep 2023
- Primary completion16 Apr 2025
- Study completion16 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tasly Pharmaceutical Group Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06006689
- Sponsor's protocol ID
- TSL-TCM-QSYQDW-DKD-Ⅱ
- Status last verified
- Mar 2026
- First submitted
- 17 Aug 2023
- Last updated
- 23 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No