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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03681249
Other study ID # 17401970500-b
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
Start date November 2, 2018
Est. completion date December 31, 2021

Study information

Verified date May 2022
Source Shanghai University of Traditional Chinese Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 112
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 ðnicity 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
China Longhua Hospital, Shanghai University of Traditional Chinese Medicine Shanghai Shanghai

Sponsors (2)

Lead Sponsor Collaborator
Shanghai University of Traditional Chinese Medicine Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 24H urine total protein t24-hour urine total protein quantitation in stage ? diabetes kidney disease patients 24 weeks
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