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Herbal Supplement

NAC active and Silibin active for Proteinuria (CGDN Trial)

Phase 2
Waitlist Available
Led By Paolo Fanti, MD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 3 months
Awards & highlights

CGDN Trial Summary

The study is done to find out whether the combined use of the nutritional supplements N-acetylcysteine and Siliphos (milk thistle extract) corrects the shedding of urine protein and oxidative damage (damage to cells and organs often compared to fast aging) in patients with Type 2 Diabetes Mellitus (T2DM) and diabetic kidney disease.

Eligible Conditions
  • Stress Oxidative
  • Proteinuria
  • Diabetic Kidney Disease

CGDN Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline in Urinary Albumin Excretion
Secondary outcome measures
Change From Baseline in Hemoglobin-A1c
Urinary Alpha-1 Microglobulin, Inflammatory Cytokines and C-C Chemokines

CGDN Trial Design

5Treatment groups
Experimental Treatment
Placebo Group
Group I: NAC placebo and Silibin activeExperimental Treatment1 Intervention
Drug: N-acetylcysteine placebo and Drug: Silibin active
Group II: NAC active and Silibin placeboExperimental Treatment1 Intervention
Drug: N-acetylcysteine and Drug: Silibin placebo
Group III: NAC active and Silibin activeExperimental Treatment1 Intervention
Drug: N-acetylcysteine active and Drug: Silibin active
Group IV: NAC active and High-dose Silibin activeExperimental Treatment1 Intervention
Drug: N-acetylcysteine active and Drug: Silibin higher dose active
Group V: NAC placebo and Silibin placeboPlacebo Group1 Intervention
Drug: N-acetylcysteine placebo and Drug: Silibin placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
N-acetylcysteine active and silibin placebo
2011
Completed Phase 2
~110
N-acetylcysteine placebo and silibin active
2011
Completed Phase 2
~110
Acetylcysteine
FDA approved
Acetylcysteine
FDA approved

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,618 Previous Clinical Trials
3,316,065 Total Patients Enrolled
1 Trials studying Proteinuria
114 Patients Enrolled for Proteinuria
National Center for Complementary and Integrative Health (NCCIH)NIH
837 Previous Clinical Trials
669,627 Total Patients Enrolled
1 Trials studying Proteinuria
114 Patients Enrolled for Proteinuria
Paolo Fanti, MDPrincipal InvestigatorSouth Texas Health Care System, San Antonio, TX
1 Previous Clinical Trials

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
N-Acetylcysteine and Milk Thistle for Treatment of Diabetic Nephropathy
2011. "N-Acetylcysteine and Milk Thistle for Treatment of Diabetic Nephropathy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01265563.
~8 spots leftby May 2025
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