Effects of PH3 in Diabetic Nephropathy

Diabetic Nephropathy Clinical Trial

— PH3  

Official title:

Effects of PH3 in Diabetic Nephropathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01068041
• Other study ID #: PH-CP016
• Status: Completed
• Phase: Phase 2
• First received: February 11, 2010
• Last updated: November 3, 2015
• Start date: August 2010
• Est. completion date: September 2015

Study information

• Verified date: November 2015
• Source: PhytoHealth Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationTaiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2015
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetic Nephropathies
• Diabetic Nephropathy
• Kidney Diseases

Intervention

Drug:
• PH3
Each PH3 tablet, 530 mg/tablet, contains 250 mg of active ingredient. The placebo tablet contains no active ingredient.

Locations

Country	Name	City	State
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	Taipei Veterans General Hospital	Taipei
Taiwan	Tri-Service General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
PhytoHealth Corporation

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary Albumin/Creatinine Ratio (UACR)		24 weeks	No
Secondary	Urine Albumin Serum Creatinine and the estimated GFR (glomerular filtration rate) HbA1c		24 weeks	No