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the Integrated Traditional Chinese and Western Medicine Treat Middle Stage DKD

Primary Purpose

Diabetic Nephropathy Type 2

Status
Completed
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
ShenqiDihuang Decoction
ShenqiDihuang Decoction placebo
Sponsored by
Shanghai University of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Nephropathy Type 2 focused on measuring Diabetic Kidney Disease，Traditional Chinese medicine

Eligibility Criteria

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

Inclusion Criteria:

  1. Identify the diagnosis of type 2 diabetes;
  2. It meets the medical history of diabetic kidney disease, according to the Mogensen diagnostic staging standard DKD IV;
  3. eGFR ≥ 30 ml / min / 1.73 m2;
  4. Age 18-75 years old, gender ＆ethnicity are not limited;
  5. glycated hemoglobin ≤ 10%;
  6. Blood pressure is controlled below 130/80mmHg

Exclusion Criteria:

  1. Combine other ACEI and ARB application indications other than hypertension;
  2. Combine severe primary diseases related to heart, brain, liver and hematopoietic system;
  3. Patients who have acute metabolic disorders such as diabetic ketoacidosis occur in the past month;
  4. Patients who HBV serological indicators except HbsAb are positive and persistent liver function test transaminase abnormalities;
  5. Patients with malignant tumors or history of malignant tumors, history of HIV infection, history of psychosis, acute central nervous system diseases, severe gastrointestinal diseases, and banned use of immunosuppressive agents;
  6. Patients with acute renal failure, combined with urinary tract infection, menstrual period, intense exercise, cold and other stress states;
  7. pregnant or lactating women;
  8. Patients who accepted other clinical trial studies on going ;
  9. Patients who combined with serious diseases and dysfunctions in other organs.

Sites / Locations

  • Longhua Hospital, Shanghai University of Traditional Chinese Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ShenqiDihuang Decoction

ShenqiDihuang Decoction placebo

Arm Description

ShenqiDihuang Decoction 150ml by mouth, twice a day for 24 weeks

ShenqiDihuang Decoction placebo 150ml by mouth, twice a day for 24 weeks

Outcomes

Primary Outcome Measures

24H urine total protein
t24-hour urine total protein quantitation in stage Ⅳ diabetes kidney disease patients

Secondary Outcome Measures

Full Information

First Posted
September 20, 2018
Last Updated
May 5, 2022
Sponsor
Shanghai University of Traditional Chinese Medicine
Collaborators
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03681249
Brief Title
the Integrated Traditional Chinese and Western Medicine Treat Middle Stage DKD
Official Title
Multicenter Clinical Study on the Treatment of Middle Stage Diabetic Kidney Disease With Integrated Traditional Chinese and Western Medicine
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
November 2, 2018 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai University of Traditional Chinese Medicine
Collaborators
Shanghai Jiao Tong University Affiliated Sixth People's Hospital

4. Oversight

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

5. Study Description

Brief Summary
Efficacy and Safety of treatment with Traditional Chinese Medicine ShenqiDihuang Decoctions in Patients with middle stage of Diabetic Kidney Disease.
Detailed Description
The study is a multi-center, randomized, double-blind, placebo-controlled trial. It is performed in Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Putuo Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, and Shanghai Baoshan District Hospital of Integrated Traditional Chinese Medicine and Western Medicine, China.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Nephropathy Type 2
Keywords
Diabetic Kidney Disease，Traditional Chinese medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ShenqiDihuang Decoction
Arm Type
Experimental
Arm Description
ShenqiDihuang Decoction 150ml by mouth, twice a day for 24 weeks
Arm Title
ShenqiDihuang Decoction placebo
Arm Type
Placebo Comparator
Arm Description
ShenqiDihuang Decoction placebo 150ml by mouth, twice a day for 24 weeks
Intervention Type
Drug
Intervention Name(s)
ShenqiDihuang Decoction
Other Intervention Name(s)
nseng, Astragalus, Rehmannia and other TCMs Decoction
Intervention Description
ShenqiDihuang Decoction 150ml twice a day for 24 weeks 150ml twice a day for 24 weeks
Intervention Type
Drug
Intervention Name(s)
ShenqiDihuang Decoction placebo
Other Intervention Name(s)
Ginseng, Astragalus, Rehmannia Decoction placebo
Intervention Description
traditional Chinese medicine placebo mimic ShenqiDihuang Decoction 150ml twice a day for 24 weeks
Primary Outcome Measure Information:
Title
24H urine total protein
Description
t24-hour urine total protein quantitation in stage Ⅳ diabetes kidney disease patients
Time Frame
24 weeks

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: Identify the diagnosis of type 2 diabetes; It meets the medical history of diabetic kidney disease, according to the Mogensen diagnostic staging standard DKD IV; eGFR ≥ 30 ml / min / 1.73 m2; Age 18-75 years old, gender ＆ethnicity are not limited; glycated hemoglobin ≤ 10%; Blood pressure is controlled below 130/80mmHg Exclusion Criteria: Combine other ACEI and ARB application indications other than hypertension; Combine severe primary diseases related to heart, brain, liver and hematopoietic system; Patients who have acute metabolic disorders such as diabetic ketoacidosis occur in the past month; Patients who HBV serological indicators except HbsAb are positive and persistent liver function test transaminase abnormalities; Patients with malignant tumors or history of malignant tumors, history of HIV infection, history of psychosis, acute central nervous system diseases, severe gastrointestinal diseases, and banned use of immunosuppressive agents; Patients with acute renal failure, combined with urinary tract infection, menstrual period, intense exercise, cold and other stress states; pregnant or lactating women; Patients who accepted other clinical trial studies on going ; Patients who combined with serious diseases and dysfunctions in other organs.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yueyi Deng, PhD
Organizational Affiliation
Shanghai University of Traditional Chinese Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Longhua Hospital, Shanghai University of Traditional Chinese Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China

12. IPD Sharing Statement

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