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Effects of PH3 in Diabetic Nephropathy (PH3)

Primary Purpose

Diabetic Nephropathy

Status
Completed
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
PH3
Sponsored by
PhytoHealth Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetic Nephropathy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Taichung Veterans General Hospital
  • Tri-Service General Hospital
  • Taipei Veterans General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

A

B

C

D

Arm Description

Placebo

250mg active ingredient

500mg active ingredient

1000mg active ingredient

Outcomes

Primary Outcome Measures

Urinary Albumin/Creatinine Ratio (UACR)

Secondary Outcome Measures

Urine Albumin Serum Creatinine and the estimated GFR (glomerular filtration rate) HbA1c

Full Information

First Posted
February 11, 2010
Last Updated
November 3, 2015
Sponsor
PhytoHealth Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01068041
Brief Title
Effects of PH3 in Diabetic Nephropathy
Acronym
PH3
Official Title
Effects of PH3 in Diabetic Nephropathy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PhytoHealth Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Nephropathy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
B
Arm Type
Active Comparator
Arm Description
250mg active ingredient
Arm Title
C
Arm Type
Active Comparator
Arm Description
500mg active ingredient
Arm Title
D
Arm Type
Active Comparator
Arm Description
1000mg active ingredient
Intervention Type
Drug
Intervention Name(s)
PH3
Intervention Description
Each PH3 tablet, 530 mg/tablet, contains 250 mg of active ingredient. The placebo tablet contains no active ingredient.
Primary Outcome Measure Information:
Title
Urinary Albumin/Creatinine Ratio (UACR)
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Urine Albumin Serum Creatinine and the estimated GFR (glomerular filtration rate) HbA1c
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males and Females between 18 and 70 years of age with type 1 or type 2 diabetes Sitting blood pressure of <=140/90 mm Hg Serum creatinine <=2.0 mg/dL Urinary albumin: creatinine ratio between 30 mg/g to 1000 mg/g creatinine (of the first urine sample of the day) Hemoglobin A1c <=8% 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 Voluntary written consent to participate in this study Exclusion Criteria: History of major cardiovascular or cerebrovascular events within 6 months prior to screening History of cancer Receiving chronic nonsteroidal anti-inflammatory therapy History of diabetic ketoacidosis 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 Has participated in other investigational trials within 28 days prior to study enrollment Has taken herbal medical treatment as prescription medication and/or over-the- counter medication, within 28 days prior to study enrollment. Has known allergy to the study drug
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wu Chang Yang, MD
Organizational Affiliation
Taipei Veterans General Hospital, Taiwan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yi-Jen Hung, MD
Organizational Affiliation
Tri-Service General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Huey-Herng Sheu, MD, PhD
Organizational Affiliation
Taichung Veterans General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
407
Country
Taiwan
Facility Name
Tri-Service General Hospital
City
Taipei
ZIP/Postal Code
114
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

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Effects of PH3 in Diabetic Nephropathy

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