CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 108 enrolled
Drug / intervention
N-acetylcysteine placebo and silibin placebo +4 moredrug
Likely dose
N-acetylcysteine active and silibin placebo 600 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01265563
NCT01265563Phase 2Completed
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Correction of Glutathione Deficiency for Treatment of Diabetic Nephropathy

VA Office of Research and Development·interventional·Posted Dec 23, 2010·Updated Oct 19, 2018

In Brief

A Phase 2 clinical trial evaluating N-acetylcysteine placebo and silibin placebo, N-acetylcysteine active and silibin placebo, and 3 other interventions for Diabetic Nephropathy and 2 related conditions. Completed, enrolled 108 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Nephropathy, Proteinuria, Oxidative Stress
CountriesUnited States
CollaboratorsNational Center for Complementary and Integrative Health (NCCIH)

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedDec 23, 2010
Enrollment StartJan 1, 2011
Primary CompletionFeb 1, 2015
Study CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 15.5 years ago

Interventions

N-acetylcysteine placebo and silibin placebodrug

Dietary Supplement: N-acetylcysteine placebo excipient and silibin placebo orally twice daily for three months

N-acetylcysteine active and silibin placebodrug

Dietary Supplement: N-acetylcysteine 600 mg orally twice daily and silibin placebo orally twice a day for three months

N-acetylcysteine placebo and silibin activedrug

Dietary Supplement: silibin 480 mg orally twice daily and N-acetylcysteine placebo orally twice a day for three months

N-acetylcysteine active and silibin activedrug

Dietary Supplement: N-acetylcysteine 600 mg orally twice daily and silibin 480 mg orally twice daily for three months

N-acetylcysteine active + high-dose silibin activedrug

Dietary Supplement: N-acetylcysteine 600 mg orally twice daily and silibin 960 mg orally twice daily for three months