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Clinical Trial of HuangKui Capsule to Treat Diabetic Kidney Disease

NCT03016832 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 414

Last updated 2017-07-05

No results posted yet for this study

Summary

1. Name of Investigational Products Huangkui capsule.
2. Trial Topic A Randomized, Double-blinded, Parallel, controlled, Multicenter Clinical Trial of Huangkui Capsule in Treating Type II Diabetic Nephropathy (DKD)
3. Trial Objectives Primary objective:To evaluate HuangKui capsule efficacy for treatment of type II diabetes ACR.

Secondary objective: To evaluate the efficacy of HuangKui capsule on 24-hour urinary protein changes、reduce PCR-increase eGFR, improve micro-inflammatory state, and improving Traditional Chinese medicine clinical efficacy
4. Trial Design Designed as a block randomized, double-blinded, parallel controlled, multi-center clinical trial.

Conditions

  • Diabetic Kidney Disease

Interventions

DRUG

Placebo drug that simulates Irbesartan tablets

Placebo drug that simulates Irbesartan tablets 150mg /qd, oral dosing

DRUG

irbesartan tablets

irbesartan tablets 150mg /qd, oral dosing

DRUG

Placebo drug that simulates HuangKui capsule

Placebo drug that simulates HuangKui capsule 2.5g/tid, oral dosing

DRUG

HuangKui Capsule

HuangKui Capsule 2.5g/tid, oral dosing.

Sponsors & Collaborators

  • Jiangsu Famous Medical Technology Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2018-05-31
Completion
2018-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03016832 on ClinicalTrials.gov