Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:46 PM
Ignite Modification Date:
2025-12-24 @ 9:46 PM
NCT ID:
NCT03016832
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03016832
Study Brief:
Protocol Section:
NCT03016832