Effects of PH3 in Diabetic Nephropathy (PH3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01068041
Recruitment Status : Completed
First Posted : February 12, 2010
Last Update Posted : November 4, 2015
Information provided by (Responsible Party):
PhytoHealth Corporation

February 11, 2010
February 12, 2010
November 4, 2015
August 2010
July 2014   (Final data collection date for primary outcome measure)
Urinary Albumin/Creatinine Ratio (UACR) [ Time Frame: 24 weeks ]
Same as current
Complete list of historical versions of study NCT01068041 on Archive Site
Urine Albumin Serum Creatinine and the estimated GFR (glomerular filtration rate) HbA1c [ Time Frame: 24 weeks ]
Same as current
Not Provided
Not Provided
Effects of PH3 in Diabetic Nephropathy
Effects of PH3 in Diabetic Nephropathy

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.

Not Provided
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Diabetic Nephropathy
Drug: PH3
Each PH3 tablet, 530 mg/tablet, contains 250 mg of active ingredient. The placebo tablet contains no active ingredient.
  • Placebo Comparator: A
    Intervention: Drug: PH3
  • Active Comparator: B
    250mg active ingredient
    Intervention: Drug: PH3
  • Active Comparator: C
    500mg active ingredient
    Intervention: Drug: PH3
  • Active Comparator: D
    1000mg active ingredient
    Intervention: Drug: PH3
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
September 2015
July 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
PhytoHealth Corporation
PhytoHealth Corporation
Not Provided
Principal Investigator: Wu Chang Yang, MD Taipei Veterans General Hospital, Taiwan
Principal Investigator: Yi-Jen Hung, MD Tri-Service General Hospital
Principal Investigator: Huey-Herng Sheu, MD, PhD Taichung Veterans General Hospital
PhytoHealth Corporation
November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP