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Completed

NCT Number: NCT01068041

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.

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Key information

Conditions

Diabetic Nephropathy Diabetes Complications Diabetes Mellitus Diabetic Nephropathies Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Taichung Veterans General Hospital, Taichung, Taiwan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PH3

Drug

Each PH3 tablet, 530 mg/tablet, contains 250 mg of active ingredient. The placebo tablet contains no active ingredient.

Primary outcomes

  1. Urinary Albumin/Creatinine Ratio (UACR)

    Time frame: 24 weeks

    Change in urinary albumin/creatinine ratio (UACR) from baseline to Week 24

Secondary outcomes

  1. Urine Albumin

    Time frame: 24 weeks

    Change in urine albumin level from baseline to Week 24

  2. Serum Creatinine

    Time frame: 24 weeks

    Change in serum creatinine level from baseline to Week 24

  3. Estimated Glomerular Filtration Rate (eGFR)

    Time frame: 24 weeks

    Change in estimated glomerular filtration rate (eGFR) from baseline to Week 24

  4. HbA1c

    Time frame: 24 weeks

    Change in HbA1c from baseline to Week 24

Sponsors and collaborators

Lead sponsor

PhytoHealth Corporation

Industry

Registry information

Acronym: PH3

Important dates

Study start
2010
Primary completion
2014
Study completion
2015
First posted
Feb 12, 2010
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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