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the Integrated Traditional Chinese and Western Medicine Treat Early Stage DKD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03681704
Recruitment Status : Recruiting
First Posted : September 24, 2018
Last Update Posted : March 17, 2021
Sponsor:
Collaborator:
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Information provided by (Responsible Party):
Shanghai University of Traditional Chinese Medicine

Study Description
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Brief Summary:
Efficacy and Safety of treatment with Traditional Chinese Medicine HuangQi Decoctions in Patients with early stage of Diabetic Kidney Disease.

Condition or disease Intervention/treatment Phase
Diabetic Nephropathy Type 2 Drug: HuangQi Decoction Drug: HuangQi Decoction placebo Early Phase 1

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Multicenter Clinical Study on the Treatment of Early Stage Diabetic Kidney Disease With Integrated Traditional Chinese and Western Medicine
Actual Study Start Date : November 8, 2018
Estimated Primary Completion Date : September 8, 2021
Estimated Study Completion Date : September 8, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: HuangQi Decoction
HuangQi Decoction 150ml by mouth ,twice a day for 24 weeks
 Drug: HuangQi Decoction
HuangQi Decoction 150ml twice a day for 24 weeks
Other Name: Astragalus and other TCMs Decoction
Placebo Comparator: HuangQi Decoction placebo
HuangQi Decoction placebo 150ml by mouth, twice a day for 24 weeks
 Drug: HuangQi Decoction placebo
traditional Chinese medicine placebo mimic HuangQi Decoction 150ml twice a day for 24 weeks
Other Name: Astragalus Decoction placebo


Outcome Measures
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Primary Outcome Measures :
  1. ACR [ Time Frame: 24 weeks ]
    the Urinary albumin/ creatinine ratios in stage Ⅲ diabetes kidney disease patients


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 III;
  3. Age 18-75 years old, gender ＆ethnicity are not limited;
  4. glycated hemoglobin ≤ 10%;
  5. 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03681704


Contacts
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Contact: Yueyi Deng, PhD 18917763063 dengyueyi@medmail.com.cn
Contact: Ji Li, PhD 021-64385700 lhtcmkyc@163.com

Locations
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China, Shanghai
Longhua Hospital, Shanghai University of Traditional Chinese Medicine Recruiting
Shanghai, Shanghai, China, 200032
Contact: Zhen Xiao         
Sponsors and Collaborators
Shanghai University of Traditional Chinese Medicine
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Investigators
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Principal Investigator: Yueyi Deng, PhD Shanghai University of Traditional Chinese Medicine
More Information
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Responsible Party: Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT03681704    
Other Study ID Numbers: 17401970500-a
First Posted: September 24, 2018    Key Record Dates
Last Update Posted: March 17, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shanghai University of Traditional Chinese Medicine:
Diabetic Kidney Disease，Traditional Chinese medicine
Additional relevant MeSH terms:
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Diabetic Nephropathies
Kidney Diseases
Urologic Diseases
 Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases