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Effects of PH3 in Diabetic Nephropathy (PH3)

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ClinicalTrials.gov Identifier: NCT01068041
Recruitment Status : Completed
First Posted : February 12, 2010
Last Update Posted : November 4, 2015
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Diabetic Nephropathy Drug: PH3 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of PH3 in Diabetic Nephropathy
Study Start Date : August 2010
Actual Primary Completion Date : July 2014
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Urinary Albumin/Creatinine Ratio (UACR) [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Urine Albumin Serum Creatinine and the estimated GFR (glomerular filtration rate) HbA1c [ Time Frame: 24 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01068041


Locations
Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan, 407
Tri-Service General Hospital
Taipei, Taiwan, 114
Taipei Veterans General Hospital
Taipei, Taiwan
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

Responsible Party: PhytoHealth Corporation
ClinicalTrials.gov Identifier: NCT01068041     History of Changes
Other Study ID Numbers: PH-CP016
First Posted: February 12, 2010    Key Record Dates
Last Update Posted: November 4, 2015
Last Verified: November 2015

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