Effects of PH3 in Diabetic Nephropathy

Phase 2

Completed

• Conditions: Diabetic Nephropathy
• Interventions: Drug: PH3

• Registration Number: NCT01068041
• Lead Sponsor: PhytoHealth Corporation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-02-11
• Study First Submitted QC: 2010-02-11
• Study First Posted: 2010-02-12
• Study Start: 2010-08
• Primary Completion: 2014-07
• Study Completion: 2015-09
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-03
• Last Update Posted: 2015-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	PH3	Placebo
B	PH3	250mg active ingredient
C	PH3	500mg active ingredient
D	PH3	1000mg active ingredient

Primary Outcome Measures

Name	Time	Method
Urinary Albumin/Creatinine Ratio (UACR)	24 weeks

Secondary Outcome Measures

Name	Time	Method
Urine Albumin Serum Creatinine and the estimated GFR (glomerular filtration rate) HbA1c	24 weeks

Trial Locations

Locations (3)

Taichung Veterans General Hospital; 🇨🇳 Taichung, Taiwan

Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan

Tri-Service General Hospital; 🇨🇳 Taipei, Taiwan