Effects of PH3 in Diabetic Nephropathy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by PhytoHealth Corporation.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
PhytoHealth Corporation
ClinicalTrials.gov Identifier:
NCT01068041
First received: February 11, 2010
Last updated: November 24, 2013
Last verified: January 2011

February 11, 2010
November 24, 2013
August 2010
December 2013   (final data collection date for primary outcome measure)
Urinary Albumin/Creatinine Ratio (UACR) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01068041 on ClinicalTrials.gov Archive Site
Urine Albumin Serum Creatinine and the estimated GFR (glomerular filtration rate) HbA1c [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
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
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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
    Placebo
    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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
December 2013
December 2013   (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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT01068041
PH-CP016
No
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
January 2011

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