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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
Are there results?
None posted in the registry

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
Show all 17Show fewer
  • 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

Other trials in China

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)

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 groups in NCT06006689
Study groupRoleWhat they receive
Placebo groupPlacebo comparatorQishen 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 groupExperimentalLow 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 groupExperimentalHigh 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.

  1. 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)

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.

  1. First posted23 Aug 2023
  2. Study start15 Sep 2023
  3. Primary completion16 Apr 2025
  4. Study completion16 Apr 2025

Resources

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)
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

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in UACR(urinary albumin ⁃ to ⁃ creatinine ratio). (time frame: Baseline to weeks 4, 8 and 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06006689.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.

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