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

March 12, 2024 updated by: Tasly Pharmaceutical Group Co., Ltd

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)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
228

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Recruiting
        • Xiyuan Hospital of China Academy of Chinese Medical Sciences
        • Contact:
      • Beijing, Beijing, China
        • Recruiting
        • Dongzhimen Hospital of Beijing University of Chinese Medicine
        • Contact:
          • Shidong Wang
          • Phone Number: 010-84012709
          • Email: dzmk@163.net
    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • The Affiliated TCM Hospital of Guangzhou Medical University
        • Contact:
    • Hebei
      • Shijiazhuang, Hebei, China
        • Recruiting
        • Hebei Province Hospital of Traditional Chinese Medicine
        • Contact:
    • Heilongjiang
      • Ha'erbin, Heilongjiang, China
        • Recruiting
        • Heilongjiang Academy of Traditional Chinese Medicine (Heilongjiang Provincial Hospital of Traditional Chinese Medicine)
        • Contact:
    • Henan
      • Kaifeng, Henan, China
        • Recruiting
        • Kaifeng Hospital of Traditional Chinese Medicine
        • Contact:
      • Luoyang, Henan, China
        • Recruiting
        • Luoyang Third People's Hospital
        • Contact:
      • Sanmenxia, Henan, China
        • Recruiting
        • Sanmenxia Central Hospital
        • Contact:
    • Hunan
      • Changsha, Hunan, China
        • Recruiting
        • The First Hospital of Hunan University of Chinese Medicine
        • Contact:
    • Shananxi
      • Xi'an, Shananxi, China
        • Recruiting
        • Shananxi Province Hospital of Traditional Chinese Medicine
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China
        • Recruiting
        • Shanghai Sixth People's Hospital
        • Contact:
      • Shanghai, Shanghai, China
        • Recruiting
        • Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China
        • Recruiting
        • West China Hospital of Sichuan University
        • Contact:
    • Tianjin
      • Tianjin, Tianjin, China
        • Recruiting
        • First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • The Second Affiliated Hospital Zhejiang University School of Medicine
        • Contact:
      • Hangzhou, Zhejiang, China
        • Recruiting
        • Hangzhou Hospital of Traditional Chinese Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo group
Qishen Yiqi Dripping Pills placebo, 3 bags, take orally after meals, 3 times a day
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
Other Names:
  • Placebo group
Experimental: Low dose group
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
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
Other Names:
  • Low dose group
Experimental: High dose group
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
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
Other Names:
  • High dose group

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in UACR(urinary albumin ⁃ to ⁃ creatinine ratio).
Time Frame: Baseline to weeks 4, 8 and 12
Change in UACR from baseline to weeks 4, 8 and 12.
Baseline to weeks 4, 8 and 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Ratio of subjects with UACR returned to normal.
Time Frame: Baseline to weeks 4, 8 and 12
Ratio of subjects with UACR returned to normal at weeks 4, 8 and 12.
Baseline to weeks 4, 8 and 12
Ratio of subjects with UACR decrease of more than 30% from baseline.
Time Frame: Baseline to weeks 4, 8 and 12
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
Ratio of subjects from microalbuminuria stage to macroalbuminuria
Time Frame: Baseline to weeks 4, 8 and 12
Ratio of subjects from microalbuminuria stage to macroalbuminuria at weeks 4, 8 and 12.
Baseline to weeks 4, 8 and 12
Change in eGFR(estimated glomerular filtration rate).
Time Frame: Baseline to weeks 4, 8 and 12
Change in eGFR from baseline to weeks 4, 8 and 12.
Baseline to weeks 4, 8 and 12
TCM syndrome
Time Frame: Baseline to weeks 4, 8 and 12
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
Change in Traditional Chinese Medicine Syndrome Score
Time Frame: Baseline to weeks 4, 8 and 12
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

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in β2-MG.
Time Frame: Baseline to weeks 4, 8 and 12
Change in β2-MG from baseline to weeks 4, 8 and 12.
Baseline to weeks 4, 8 and 12
Change in Cys-C.
Time Frame: Baseline to weeks 4, 8 and 12
Change in Cys-C from baseline to weeks 4, 8 and 12.
Baseline to weeks 4, 8 and 12
Change in PCX.
Time Frame: Baseline to week 12
Change in PCX from baseline to week 12.
Baseline to week 12
Change in MCP-1.
Time Frame: Baseline to week 12
Change in MCP-1 from baseline to week 12.
Baseline to week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tasly Pharmaceutical Group Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 4, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 17, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 23, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 13, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TSL-TCM-QSYQDW-DKD-Ⅱ

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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