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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  Recruiting
Sponsor:
Information provided by:
PhytoHealth Corporation
ClinicalTrials.gov Identifier:
NCT01068041
First received: February 11, 2010
Last updated: January 4, 2011
Last verified: January 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Diabetic Nephropathy
 Drug: PH3
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of PH3 in Diabetic Nephropathy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by PhytoHealth Corporation:

Primary Outcome Measures:
  • Urinary Albumin/Creatinine Ratio (UACR) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Urine Albumin Serum Creatinine and the estimated GFR (glomerular filtration rate) HbA1c [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: August 2010
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: A
Placebo
 Drug: PH3
Each PH3 tablet, 530 mg/tablet, contains 250 mg of active ingredient. The placebo tablet contains no active ingredient.
Active Comparator: B
250mg active ingredient
 Drug: PH3
Each PH3 tablet, 530 mg/tablet, contains 250 mg of active ingredient. The placebo tablet contains no active ingredient.
Active Comparator: C
500mg active ingredient
 Drug: PH3
Each PH3 tablet, 530 mg/tablet, contains 250 mg of active ingredient. The placebo tablet contains no active ingredient.
Active Comparator: D
1000mg active ingredient
 Drug: PH3
Each PH3 tablet, 530 mg/tablet, contains 250 mg of active ingredient. The placebo tablet contains no active ingredient.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01068041

Locations
Taiwan
Taichung Veterans General Hospital Recruiting
Taichung, Taiwan, 407
Contact: Hui-Ying Lee, BS     886-4-23592525 ext 3075     melody@vghtc.gov.tw    
Principal Investigator: Huey-Herng Sheu, MD, PhD            
Taipei Veterans General Hospital Not yet recruiting
Taipei, Taiwan
Contact: Yen Han Lai     886-2-25453697 ext 355     laiyh@phytohealth.com.tw    
Principal Investigator: Wu Chang Yang, MD            
Tri-Service General Hospital Recruiting
Taipei, Taiwan, 114
Contact: Su-Chen Wang, BS     886-2-87927182     suchentw@yahoo.com.tw    
Principal Investigator: Yi-Jen Hung, MD            
Sponsors and Collaborators
PhytoHealth Corporation
Investigators
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
  More Information

No publications provided

Responsible Party: Yen-Han Lai / Project Manager, Phytohealth Corporation
ClinicalTrials.gov Identifier: NCT01068041     History of Changes
Other Study ID Numbers: PH-CP016
Study First Received: February 11, 2010
Last Updated: January 4, 2011
Health Authority: United States: Food and Drug Administration
Taiwan: Department of Health

Additional relevant MeSH terms:
Diabetic Nephropathies
Kidney Diseases
Urologic Diseases
 Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 23, 2013