Effects of PH3 in Diabetic Nephropathy

NCT01068041 | Completed Phase 2

• 1 other identifier: PH-CP016
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

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.

Conditions

Diabetic Nephropathy

Outcome Measures

Primary Outcomes (1)

• Urinary Albumin/Creatinine Ratio (UACR)

  24 weeks

Secondary Outcomes (1)

• Urine Albumin Serum Creatinine and the estimated GFR (glomerular filtration rate) HbA1c

  24 weeks

Study Arms (4)

A

PLACEBO COMPARATOR

Placebo

Drug: PH3

B

ACTIVE COMPARATOR

250mg active ingredient

Drug: PH3

C

ACTIVE COMPARATOR

500mg active ingredient

Drug: PH3

D

ACTIVE COMPARATOR

1000mg active ingredient

Drug: PH3

Interventions

PH3 DRUG

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

A; B; C; D

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• PhytoHealth Corporation: lead

Study Sites (3)

Taichung Veterans General Hospital

Taichung, 407, Taiwan

Location

Tri-Service General Hospital

Taipei, 114, Taiwan

Location

Taipei Veterans General Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Diabetic Nephropathies

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2010
• First Posted: February 12, 2010
• Study Start: August 1, 2010
• Primary Completion: July 1, 2014
• Study Completion: September 1, 2015
• Last Updated: June 5, 2025

Record last verified: 2025-06

Locations

TW (3)