the Integrated Traditional Chinese and Western Medicine Treat Middle Stage DKD

NCT03681249 | Completed Early Phase 1

• 1 other identifier: 17401970500-b
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

Efficacy and Safety of treatment with Traditional Chinese Medicine ShenqiDihuang Decoctions in Patients with middle stage of Diabetic Kidney Disease.

Conditions

Diabetic Nephropathy Type 2

Keywords

Diabetic Kidney Disease，Traditional Chinese medicine

Outcome Measures

Primary Outcomes (1)

• 24H urine total protein

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

  24 weeks

Study Arms (2)

ShenqiDihuang Decoction

EXPERIMENTAL

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

Drug: ShenqiDihuang Decoction

ShenqiDihuang Decoction placebo

PLACEBO COMPARATOR

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

Drug: ShenqiDihuang Decoction placebo

Interventions

ShenqiDihuang Decoction DRUG

ShenqiDihuang Decoction 150ml twice a day for 24 weeks 150ml twice a day for 24 weeks

Also known as: nseng, Astragalus, Rehmannia and other TCMs Decoction

ShenqiDihuang Decoction

ShenqiDihuang Decoction placebo DRUG

traditional Chinese medicine placebo mimic ShenqiDihuang Decoction 150ml twice a day for 24 weeks

Also known as: Ginseng, Astragalus, Rehmannia Decoction placebo

ShenqiDihuang Decoction placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai University of Traditional Chinese Medicine: lead
• Shanghai Jiao Tong University Affiliated Sixth People's Hospital: collaborator

Study Sites (1)

Longhua Hospital, Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Interventions

Asian ginseng

Study Officials

• Yueyi Deng, PhD

  Shanghai University of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2018
• First Posted: September 24, 2018
• Study Start: November 2, 2018
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: May 6, 2022

Record last verified: 2022-05

Locations

CN (1)