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the Integrated Traditional Chinese and Western Medicine Treat Early Stage DKD

S

Shanghai University of Traditional Chinese Medicine

Status and phase

Completed
Phase 1

Conditions

Diabetic Nephropathy Type 2

Treatments

Drug: HuangQi Decoction
Drug: HuangQi Decoction placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT03681704
17401970500-a

Details and patient eligibility

About

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

Full 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.

Enrollment

96 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

96 participants in 2 patient groups, including a placebo group

HuangQi Decoction
Experimental group
Description:
HuangQi Decoction 150ml by mouth ,twice a day for 24 weeks
Treatment:
Drug: HuangQi Decoction
HuangQi Decoction placebo
Placebo Comparator group
Description:
HuangQi Decoction placebo 150ml by mouth, twice a day for 24 weeks
Treatment:
Drug: HuangQi Decoction placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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