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NCT01265563 · ClinicalTrials.gov registry record · Phase 2
N-Acetylcysteine and Milk Thistle for Treatment of Diabetic Nephropathy
A Phase 2 study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 108
- Enrollment target
NCT01265563: Completed Phase 2 study, sponsored by VA Office of Research and Development.
NCT01265563 is a Phase 2 study that has completed, run by VA Office of Research and Development. The registered enrollment target is 108 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (19% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01265563, a Phase 2 study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 108 participants
- Enrollment target
Study 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.
Primary Outcome
Urine albumin to creatinine ratio was assessed at the end of run in period and after 3 months administration of study intervention.
Interventions
- DRUG N-acetylcysteine placebo and silibin placebo
- DRUG N-acetylcysteine active and silibin placebo
- DRUG N-acetylcysteine placebo and silibin active
- DRUG N-acetylcysteine active and silibin active
- DRUG N-acetylcysteine active + high-dose silibin active
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 108 participants |
| Start Date | 2011-01 |
| Est. Completion | 2016-12 |
| Phase | Phase 2 |
What the finished NCT01265563 record still lists
NCT01265563 is an interventional study that assigns participants to a tested intervention. The registered 108 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (19% lower).
The record links to 0 conditions, and to 5 interventions - of which N-acetylcysteine placebo and silibin placebo is the first listed.
NCT01265563 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01265563 about?
NCT01265563 is a clinical study titled "N-Acetylcysteine and Milk Thistle for Treatment of Diabetic Nephropathy". 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 (...
What is the current status of trial NCT01265563?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 108 participants. The study started on 2011-01. Estimated completion is 2016-12.
What interventions are being tested in trial NCT01265563?
The interventions under investigation include: N-acetylcysteine placebo and silibin placebo (DRUG), N-acetylcysteine active and silibin placebo (DRUG), N-acetylcysteine placebo and silibin active (DRUG), N-acetylcysteine active and silibin active (DRUG), N-acetylcysteine active + high-dose silibin active (DRUG).
Who is sponsoring clinical trial NCT01265563?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01265563's enrollment target sits among peer trials
108 640th of 2000 higher than 1,355 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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