Diabetic Nephropathy
Conditions
Brief summary
The primary objective of this clinical study is to evaluate the effectiveness and safety of PH3 for patients with diabetic nephropathy. The secondary objectives are to identify the optimal dosage for subsequent studies and to provide basis for the next confirmatory study in study design, endpoints, and study methodologies.
Interventions
DRUGPH3
Each PH3 tablet, 530 mg/tablet, contains 250 mg of active ingredient. The placebo tablet contains no active ingredient.
Sponsors
PhytoHealth Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Males and Females between 18 and 70 years of age with type 1 or type 2 diabetes 2. Sitting blood pressure of \<=140/90 mm Hg 3. Serum creatinine \<=2.0 mg/dL 4. Urinary albumin: creatinine ratio between 30 mg/g to 1000 mg/g creatinine (of the first urine sample of the day) 5. Hemoglobin A1c \<=8% 6. Women of child-bearing potential must test negative in a pregnancy test and take contraception measures to prevent pregnancy and can not be breast-feeding 7. Voluntary written consent to participate in this study
Exclusion criteria
1. History of major cardiovascular or cerebrovascular events within 6 months prior to screening 2. History of cancer 3. Receiving chronic nonsteroidal anti-inflammatory therapy 4. History of diabetic ketoacidosis 5. Has clinically significant deviation from normal physical examination findings that, in the principal investigator's judgment, may interfere with the study evaluation or affect subject safety 6. Has participated in other investigational trials within 28 days prior to study enrollment 7. Has taken herbal medical treatment as prescription medication and/or over-the- counter medication, within 28 days prior to study enrollment. 8. Has known allergy to the study drug
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urinary Albumin/Creatinine Ratio (UACR) | 24 weeks | Change in urinary albumin/creatinine ratio (UACR) from baseline to Week 24 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Urine Albumin | 24 weeks | Change in urine albumin level from baseline to Week 24 |
| Serum Creatinine | 24 weeks | Change in serum creatinine level from baseline to Week 24 |
| Estimated Glomerular Filtration Rate (eGFR) | 24 weeks | Change in estimated glomerular filtration rate (eGFR) from baseline to Week 24 |
| HbA1c | 24 weeks | Change in HbA1c from baseline to Week 24 |
Countries
Taiwan
Contacts
PRINCIPAL_INVESTIGATORWu Chang Yang, MD
Taipei Veterans General Hospital, Taiwan
PRINCIPAL_INVESTIGATORYi-Jen Hung, MD
Tri-Service General Hospital
PRINCIPAL_INVESTIGATORHuey-Herng Sheu, MD, PhD
Taichung Veterans General Hospital
Outcome results
None listed