search
Back to results

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

Primary Purpose

Diabetic Kidney Disease

Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Qishen Yiqi Dripping Pills placebo 3 bags
Low dose Qishen Yiqi Dripping Pills 3 bags
High dose Qishen Yiqi Dripping Pills 3 bags
Sponsored by
Tasly Pharmaceutical Group Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Kidney Disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dongzhimen Hospital of Beijing University of Chinese Medicine
  • Xiyuan Hospital of China Academy of Chinese Medical Sciences
  • The Affiliated TCM Hospital of Guangzhou Medical University
  • Hebei Province Hospital of Traditional Chinese Medicine
  • Heilongjiang Academy of Traditional Chinese Medicine (Heilongjiang Provincial Hospital of Traditional Chinese Medicine)
  • Kaifeng Hospital of Traditional Chinese Medicine
  • Luoyang Third People's Hospital
  • Sanmenxia Central Hospital
  • The First Hospital of Hunan University of Chinese Medicine
  • Shananxi Province Hospital of Traditional Chinese Medicine
  • Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine
  • Shanghai Sixth People's Hospital
  • West China Hospital of Sichuan University
  • First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
  • Hangzhou hospital of traditional Chinese medicine
  • The Second Affiliated Hospital Zhejiang University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo group

Low dose group

High dose group

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Change in UACR(urinary albumin ⁃ to ⁃ creatinine ratio).
Change in UACR from baseline to weeks 4, 8 and 12.

Secondary Outcome Measures

Ratio of subjects with UACR returned to normal.
Ratio of subjects with UACR returned to normal at 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.
Ratio of subjects from microalbuminuria stage to macroalbuminuria
Ratio of subjects from microalbuminuria stage to macroalbuminuria at weeks 4, 8 and 12.
Change in eGFR(estimated glomerular filtration rate).
Change in eGFR from 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.
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.

Full Information

First Posted
August 17, 2023
Last Updated
August 22, 2023
Sponsor
Tasly Pharmaceutical Group Co., Ltd
search

1. Study Identification

Unique Protocol Identification Number
NCT06006689
Brief Title
Efficacy and Safety of QiShen YiQi Dripping Pills in the Treatment of Diabetic Kidney Disease (Syndrome of Qi Deficiency With Blood Stasis)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
September 1, 2025 (Anticipated)
Study Completion Date
September 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tasly Pharmaceutical Group Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Kidney Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
228 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Qishen Yiqi Dripping Pills placebo, 3 bags, take orally after meals, 3 times a day
Arm Title
Low dose group
Arm Type
Experimental
Arm Description
Low dose Qishen Yiqi Dripping Pills, 3 bags, take orally after meals, 3 times a day
Arm Title
High dose group
Arm Type
Experimental
Arm Description
High dose Qishen Yiqi Dripping Pills, 3 bags, take orally after meals, 3 times a day
Intervention Type
Drug
Intervention Name(s)
Qishen Yiqi Dripping Pills placebo 3 bags
Other Intervention Name(s)
Placebo group
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Low dose Qishen Yiqi Dripping Pills 3 bags
Other Intervention Name(s)
Low dose group
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
High dose Qishen Yiqi Dripping Pills 3 bags
Other Intervention Name(s)
High dose group
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in UACR(urinary albumin ⁃ to ⁃ creatinine ratio).
Description
Change in UACR from baseline to weeks 4, 8 and 12.
Time Frame
Baseline to weeks 4, 8 and 12
Secondary Outcome Measure Information:
Title
Ratio of subjects with UACR returned to normal.
Description
Ratio of subjects with UACR returned to normal at weeks 4, 8 and 12.
Time Frame
Baseline to weeks 4, 8 and 12
Title
Ratio of subjects with UACR decrease of more than 30% from baseline.
Description
Ratio of subjects with UACR decrease of more than 30% from baseline at weeks 4, 8 and 12.
Time Frame
Baseline to weeks 4, 8 and 12
Title
Ratio of subjects from microalbuminuria stage to macroalbuminuria
Description
Ratio of subjects from microalbuminuria stage to macroalbuminuria at weeks 4, 8 and 12.
Time Frame
Baseline to weeks 4, 8 and 12
Title
Change in eGFR(estimated glomerular filtration rate).
Description
Change in eGFR from baseline to weeks 4, 8 and 12.
Time Frame
Baseline to weeks 4, 8 and 12
Title
Change in Traditional Chinese Medicine Syndrome Score
Description
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.
Time Frame
Baseline to weeks 4, 8 and 12
Title
TCM syndrome
Description
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.
Time Frame
Baseline to weeks 4, 8 and 12
Other Pre-specified Outcome Measures:
Title
Change in β2-MG.
Description
Change in β2-MG from baseline to weeks 4, 8 and 12.
Time Frame
Baseline to weeks 4, 8 and 12
Title
Change in Cys-C.
Description
Change in Cys-C from baseline to weeks 4, 8 and 12.
Time Frame
Baseline to weeks 4, 8 and 12
Title
Change in PCX.
Description
Change in PCX from baseline to week 12.
Time Frame
Baseline to week 12
Title
Change in MCP-1.
Description
Change in MCP-1 from baseline to week 12.
Time Frame
Baseline to week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rui Liu
Phone
022-86343626
Email
liurui2@tasly.com
Facility Information:
Facility Name
Dongzhimen Hospital of Beijing University of Chinese Medicine
City
Beijing
State/Province
Beijing
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shidong Wang
Phone
010-84012709
Email
dzmk@163.net
Facility Name
Xiyuan Hospital of China Academy of Chinese Medical Sciences
City
Beijing
State/Province
Beijing
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Renhuan Yu
Phone
010-62835646
Email
xiyuan5649@126.com
Facility Name
The Affiliated TCM Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenying Wang
Phone
020-81226210
Email
gcp6335@163.com
Facility Name
Hebei Province Hospital of Traditional Chinese Medicine
City
Shijiazhuang
State/Province
Hebei
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinchuan Tan
Phone
0311-69095606
Email
szyyyxllh@126.com
Facility Name
Heilongjiang Academy of Traditional Chinese Medicine (Heilongjiang Provincial Hospital of Traditional Chinese Medicine)
City
Ha'erbin
State/Province
Heilongjiang
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaojun Cai
Phone
0451-86096799
Email
30393458@qq.com
Facility Name
Kaifeng Hospital of Traditional Chinese Medicine
City
Kaifeng
State/Province
Henan
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fang Zhang
Phone
0371-22868815
Email
kfszyyllwyh@163.com
Facility Name
Luoyang Third People's Hospital
City
Luoyang
State/Province
Henan
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junhang Tian
Phone
0379-63963566
Email
lysygcp@163.com
Facility Name
Sanmenxia Central Hospital
City
Sanmenxia
State/Province
Henan
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yunchou Ning
Phone
0398-3118657
Email
zxyyjgb888@126.com
Facility Name
The First Hospital of Hunan University of Chinese Medicine
City
Changsha
State/Province
Hunan
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoling Zou
Phone
0731-85369039
Email
zyfyjigouban@163.com
Facility Name
Shananxi Province Hospital of Traditional Chinese Medicine
City
Xi'an
State/Province
Shananxi
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yang Xiao
Phone
029-87251691
Email
sxzyjgb@126.com
Facility Name
Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine
City
Shanghai
State/Province
Shanghai
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hua Yang
Phone
021-64385700
Email
lhgcpoffice@126.com
Facility Name
Shanghai Sixth People's Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Niansong Wang
Phone
021-24056429
Email
liuyuangcp@163.com
Facility Name
West China Hospital of Sichuan University
City
Chengdu
State/Province
Sichuan
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Zhou
Phone
028-85423237
Email
huaxigcp@163.com
Facility Name
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
City
Tianjin
State/Province
Tianjin
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bin Wang
Phone
022-27986257
Email
yfyjdb@163.com
Facility Name
Hangzhou hospital of traditional Chinese medicine
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongyu Chen
Phone
0571-85827896
Email
hzgxgcp@163.com
Facility Name
The Second Affiliated Hospital Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chao Zheng
Phone
0571-87783759
Email
ruanzr@126.com

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs