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Clinical Trial of HuangKui Capsule to Treat Diabetic Kidney Disease

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ClinicalTrials.gov Identifier: NCT03016832
Recruitment Status : Recruiting
First Posted : January 11, 2017
Last Update Posted : July 5, 2017
Sponsor:
Information provided by (Responsible Party):
Jiangsu Famous Medical Technology Co., Ltd.

Brief 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.

Condition or disease Intervention/treatment Phase
Diabetic Kidney Disease Drug: Placebo drug that simulates Irbesartan tablets Drug: irbesartan tablets Drug: Placebo drug that simulates HuangKui capsule Drug: HuangKui Capsule Early Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 414 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Parallel-controlled, Multi-center Clinical Trial of HuangKui Capsule to Treat Diabetic Kidney Disease
Study Start Date : January 2017
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Irbesartan

Arm Intervention/treatment
Experimental: Huangkui
Placebo drug that simulates Irbesartan tablets 150mg /qd, oral dosing; HuangKui Capsule 2.5g/tid, oral dosing
Drug: Placebo drug that simulates Irbesartan tablets
Placebo drug that simulates Irbesartan tablets 150mg /qd, oral dosing

Drug: HuangKui Capsule
HuangKui Capsule 2.5g/tid, oral dosing.

Active Comparator: controlled
Placebo drug that simulates Irbesartan tablets 150mg /qd, oral dosing; HuangKui Capsule 2.5g/tid, oral dosing irbesartan tablets 150mg /qd, oral dosing; Placebo drug that simulates HuangKui capsule 2.5g/tid, 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

combined treatment
irbesartan tablets 150mg /qd, oral dosing HuangKui Capsule 2.5g/tid, oral dosing.
Drug: irbesartan tablets
irbesartan tablets 150mg /qd, oral dosing

Drug: HuangKui Capsule
HuangKui Capsule 2.5g/tid, oral dosing.




Primary Outcome Measures :
  1. ACR [ Time Frame: every 4 week,a total of 24 weeks ]
    ACR baseline changes and changes in the rate


Secondary Outcome Measures :
  1. 24-hour urinary protein [ Time Frame: every 4 week,,a total of 24 weeks ]
    24-hour urinary protein quantification baseline changes and changes in the rate

  2. PCR [ Time Frame: every 12 week,,a total of 24 weeks ]
    PCR baseline changes and changing rat

  3. Glomerular filtration rate [ Time Frame: every 12 week,,a total of 24 weeks ]
    Glomerular filtration rate (eGFR) baseline changes

  4. TCM syndromes Efficacy endpoint [ Time Frame: baseline,12-weeks treatment,24-weeks treatment ]
    Changes and the rate change before and after treatment.

  5. High sensitivity C [ Time Frame: baseline,12-weeks treatment,24-weeks treatment ]
    High sensitivity C - reactive protein baseline values



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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. Aged 18 to 75 years old, male or female
  2. Meet the diagnostic criteria of type 2 diabetes published by the World Health Organization (WHO) in 1999: fasting plasma glucose>126mg/dL (or>7.0mmol/L), 2h postprandial blood glucose>200mg/dL (or>11.1mmol/L), or 2h blood glucose in OGTT test>200mg/dL(11.1mmol/L), random blood glucose test≥200mg/dL(11.1mmol/L)
  3. Meet Diabetic Kidney Disease (DKD) and the United States Diabetes Association (ADA) and the American Kidney Foundation (NKF) diagnostic criteria in 2007 ; 300mg/g ≤ ACR <2000mg/g
  4. e-GFR>30 mL/min (CKD-Epi formula),
  5. Glycated hemoglobin ≤8.5%
  6. Agree to sign informed consent form.

Exclusion Criteria:

  1. Type 1 diabetes
  2. Other secondary glomerulonephritis caused by Non-diabetes disease;
  3. Taking Huangkui capsule, ACEI and / or ARB drugs within 2 months;
  4. Taking glucocorticoid, immunosuppressive agents and Tripterygium wilfordii drug history within one month;
  5. Taking three or more antihypertensive drugs, but the blood pressure is still>160/90mmHg
  6. With other diseases, syndromes, or comorbidities that may affect the diagnosis and therapeutic effect of the target indications
  7. The treatments received may affect the evaluation of efficacy and safety endpoints
  8. With phychological or pathological conditions which may affect the evaluation of efficacy endpoints and safety endpointssuch as the menstrual period, or heart, brain, liver and hematopoietic system and other serious primary disease
  9. With high risk, such as pregnant women or childbearing during the trial, be allergy to the Abelmoschus Moschatus Capsule and irbesartan, in the dangerous condition with unexpected accidents.
  10. Alcohol or drug abuse
  11. Noncompliance, such as unwilling to accept research procedures or suffering from mental illness and other diseases
  12. Other: Such as poor compliance, or can not attend the follow-up visit in time for some reasons;
  13. Is participating in another clinical study.

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): NCT03016832


Contacts
Contact: Wei Sun, Doctor 13505199801 jssunwei@163.com

Locations
China, Jiangsu
Jiangsu Province Hospital of TCM Recruiting
Nanjing, Jiangsu, China
Contact: Wei Sun    +86 13505199801    jssunwei@163.com   
Sponsors and Collaborators
Jiangsu Famous Medical Technology Co., Ltd.

Responsible Party: Jiangsu Famous Medical Technology Co., Ltd.
ClinicalTrials.gov Identifier: NCT03016832     History of Changes
Other Study ID Numbers: SZCT-2016-01
First Posted: January 11, 2017    Key Record Dates
Last Update Posted: July 5, 2017
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Diabetic Nephropathies
Kidney Diseases
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Irbesartan
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action