Effects of PH3 in Diabetic Nephropathy

NCT ID: NCT01068041

Last Updated: 2025-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2015-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

A

Placebo

Group Type: PLACEBO_COMPARATOR

PH3

Intervention Type: DRUG

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

B

250mg active ingredient

Group Type: ACTIVE_COMPARATOR

PH3

Intervention Type: DRUG

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

C

500mg active ingredient

Group Type: ACTIVE_COMPARATOR

PH3

Intervention Type: DRUG

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

D

1000mg active ingredient

Group Type: ACTIVE_COMPARATOR

PH3

Intervention Type: DRUG

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

Interventions

PH3

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PhytoHealth Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wu Chang Yang, MD

Role: PRINCIPAL_INVESTIGATOR

Taipei Veterans General Hospital, Taiwan

Yi-Jen Hung, MD

Role: PRINCIPAL_INVESTIGATOR

Tri-Service General Hospital

Huey-Herng Sheu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Taichung Veterans General Hospital

Locations

Taichung Veterans General Hospital

Taichung, , Taiwan

Tri-Service General Hospital

Taipei, , Taiwan

Taipei Veterans General Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

PH-CP016

Identifier Type: -

Identifier Source: org_study_id