Trial Outcomes & Findings for N-Acetylcysteine and Milk Thistle for Treatment of Diabetic Nephropathy (NCT NCT01265563)
NCT ID: NCT01265563
Last Updated: 2018-10-19
Results Overview
Urine albumin to creatinine ratio was assessed at the end of run in period and after 3 months administration of study intervention.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
108 participants
Primary outcome timeframe
Baseline and 3 months
Results posted on
2018-10-19
Participant Flow
213 subjects met the inclusion criteria on screening from 2 clinic locations: VA and University Hospital Renal clinics.Many had exclusion criteria and few refused to participate. 108 subjects finally enrolled in the study.
During Run-in phase before randomization to the experimental arms, 4 subjects were excluded due to hospitalization for various reasons and 26 were excluded due to issues with transportation or sickness in the family or themselves.
Participant milestones
| Measure |
NAC Placebo + Silibin Placebo
N-acetylcysteine placebo + silibin placebo Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months Other Name: NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo
N-acetylcysteine placebo + silibin placebo: Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months
|
NAC Active + Silibin Placebo
N-acetylcysteine active + silibin placebo Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo
N-acetylcysteine active + silibin placebo: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months
|
NAC Placebo + Silibin Active
N-acetylcysteine placebo + silibin active Dietary Supplement: silibin 480 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months Other Name: NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo
N-acetylcysteine placebo + silibin active: Dietary Supplement: silibin 480 mg orally twice daily for three months
* (Other Name) Silibin-phosphatidylcholine placebo, Siliphos placebo
* (Other Name) NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months
|
NAC Active + Silibin Active
N-acetylcysteine active + silibin active Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: silibin 480 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo
N-acetylcysteine active + silibin active: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months
* (Other Name): NAC Dietary Supplement: silibin 480 mg orally twice daily for three months Silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months
* (Other Name): Silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months
|
NAC Active + High Dose Silibin Active
N-acetylcysteine active + high-dose silibin active Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: high-dose silibin 960 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos
N-acetylcysteine active + high-dose silibin active: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
16
|
13
|
17
|
16
|
16
|
|
Overall Study
COMPLETED
|
16
|
12
|
16
|
16
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
0
|
2
|
Reasons for withdrawal
| Measure |
NAC Placebo + Silibin Placebo
N-acetylcysteine placebo + silibin placebo Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months Other Name: NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo
N-acetylcysteine placebo + silibin placebo: Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months
|
NAC Active + Silibin Placebo
N-acetylcysteine active + silibin placebo Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo
N-acetylcysteine active + silibin placebo: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months
|
NAC Placebo + Silibin Active
N-acetylcysteine placebo + silibin active Dietary Supplement: silibin 480 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months Other Name: NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo
N-acetylcysteine placebo + silibin active: Dietary Supplement: silibin 480 mg orally twice daily for three months
* (Other Name) Silibin-phosphatidylcholine placebo, Siliphos placebo
* (Other Name) NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months
|
NAC Active + Silibin Active
N-acetylcysteine active + silibin active Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: silibin 480 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo
N-acetylcysteine active + silibin active: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months
* (Other Name): NAC Dietary Supplement: silibin 480 mg orally twice daily for three months Silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months
* (Other Name): Silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months
|
NAC Active + High Dose Silibin Active
N-acetylcysteine active + high-dose silibin active Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: high-dose silibin 960 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos
N-acetylcysteine active + high-dose silibin active: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months
|
|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
0
|
2
|
Baseline Characteristics
N-Acetylcysteine and Milk Thistle for Treatment of Diabetic Nephropathy
Baseline characteristics by cohort
| Measure |
NAC Placebo and Silibin Placebo
n=16 Participants
N-acetylcysteine placebo + silibin placebo Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months Other Name: NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo
N-acetylcysteine placebo + silibin placebo: Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months
|
NAC Active and Silibin Placebo
n=13 Participants
N-acetylcysteine active + silibin placebo Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo
N-acetylcysteine active + silibin placebo: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months
|
NAC Placebo and Silibin Active
n=17 Participants
N-acetylcysteine placebo + silibin active Dietary Supplement: silibin 480 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months Other Name: NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo
N-acetylcysteine placebo + silibin active: Dietary Supplement: silibin 480 mg orally twice daily for three months
* (Other Name) Silibin-phosphatidylcholine placebo, Siliphos placebo
* (Other Name) NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months
|
NAC Active and Silibin Active
n=16 Participants
N-acetylcysteine active + silibin active Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: silibin 480 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo
N-acetylcysteine active + silibin active: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months
* (Other Name): NAC Dietary Supplement: silibin 480 mg orally twice daily for three months Silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months
* (Other Name): Silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months
|
NAC Active and High-dose Silibin Active
n=16 Participants
N-acetylcysteine active + high-dose silibin active Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: high-dose silibin 960 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos
N-acetylcysteine active + high-dose silibin active: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months
|
Total
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Customized
Age
|
65.3 years
STANDARD_DEVIATION 5.74 • n=5 Participants
|
64 years
STANDARD_DEVIATION 6.4 • n=7 Participants
|
61.9 years
STANDARD_DEVIATION 8.39 • n=5 Participants
|
64.81 years
STANDARD_DEVIATION 8.113 • n=4 Participants
|
59.56 years
STANDARD_DEVIATION 7.78 • n=21 Participants
|
63.09 years
STANDARD_DEVIATION 7.5 • n=8 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
71 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
71 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
BMI
|
30.21 kg/M^2
STANDARD_DEVIATION 9.28 • n=5 Participants
|
39.9 kg/M^2
STANDARD_DEVIATION 9.17 • n=7 Participants
|
35.86 kg/M^2
STANDARD_DEVIATION 8.63 • n=5 Participants
|
35.65 kg/M^2
STANDARD_DEVIATION 5.16 • n=4 Participants
|
35.72 kg/M^2
STANDARD_DEVIATION 7.5 • n=21 Participants
|
35.31 kg/M^2
STANDARD_DEVIATION 7.67 • n=8 Participants
|
|
Systolic BP
|
138.5 mmHg
STANDARD_DEVIATION 21.76 • n=5 Participants
|
125.54 mmHg
STANDARD_DEVIATION 22.77 • n=7 Participants
|
147.41 mmHg
STANDARD_DEVIATION 16.8 • n=5 Participants
|
137.13 mmHg
STANDARD_DEVIATION 17.10 • n=4 Participants
|
142.8 mmHg
STANDARD_DEVIATION 12 • n=21 Participants
|
139.15 mmHg
STANDARD_DEVIATION 19.02 • n=8 Participants
|
|
Diastolic BP
|
70.44 mmHg
STANDARD_DEVIATION 15.83 • n=5 Participants
|
62.71 mmHg
STANDARD_DEVIATION 12.63 • n=7 Participants
|
77.47 mmHg
STANDARD_DEVIATION 9.53 • n=5 Participants
|
70.88 mmHg
STANDARD_DEVIATION 8.37 • n=4 Participants
|
74.25 mmHg
STANDARD_DEVIATION 9.61 • n=21 Participants
|
71.93 mmHg
STANDARD_DEVIATION 12.08 • n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline and 3 monthsUrine albumin to creatinine ratio was assessed at the end of run in period and after 3 months administration of study intervention.
Outcome measures
| Measure |
NAC Placebo + Silibin Placebo
n=16 Participants
N-acetylcysteine placebo + silibin placebo Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months Other Name: NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo
N-acetylcysteine placebo + silibin placebo: Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months
|
NAC Active + Silibin Placebo
n=12 Participants
N-acetylcysteine active + silibin placebo Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo
N-acetylcysteine active + silibin placebo: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months
|
NAC Placebo + Silibin Active
n=16 Participants
N-acetylcysteine placebo + silibin active Dietary Supplement: silibin 480 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months Other Name: NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo
N-acetylcysteine placebo + silibin active: Dietary Supplement: silibin 480 mg orally twice daily for three months
* (Other Name) Silibin-phosphatidylcholine placebo, Siliphos placebo
* (Other Name) NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months
|
NAC Active + Silibin Active
n=16 Participants
N-acetylcysteine active + silibin active Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: silibin 480 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo
N-acetylcysteine active + silibin active: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months
* (Other Name): NAC Dietary Supplement: silibin 480 mg orally twice daily for three months Silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months
* (Other Name): Silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months
|
NAC Active + High-dose Silibin Active
n=14 Participants
N-acetylcysteine active + high-dose silibin active Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: high-dose silibin 960 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos
N-acetylcysteine active + high-dose silibin active: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months
|
|---|---|---|---|---|---|
|
Change From Baseline in Urinary Albumin Excretion
|
50.5 mg/g
Standard Deviation 291.2
|
-28.13 mg/g
Standard Deviation 578.32
|
-4.5 mg/g
Standard Deviation 541
|
96.6 mg/g
Standard Deviation 422.4
|
353.71 mg/g
Standard Deviation 732.67
|
SECONDARY outcome
Timeframe: Baseline and 3 monthsHemoglobin A1C was assessed at the end of the run in period and after 3 months of administration of study interventions. Here is delta HgA1C is reported between the two periods
Outcome measures
| Measure |
NAC Placebo + Silibin Placebo
n=16 Participants
N-acetylcysteine placebo + silibin placebo Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months Other Name: NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo
N-acetylcysteine placebo + silibin placebo: Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months
|
NAC Active + Silibin Placebo
n=12 Participants
N-acetylcysteine active + silibin placebo Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo
N-acetylcysteine active + silibin placebo: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months
|
NAC Placebo + Silibin Active
n=16 Participants
N-acetylcysteine placebo + silibin active Dietary Supplement: silibin 480 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months Other Name: NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo
N-acetylcysteine placebo + silibin active: Dietary Supplement: silibin 480 mg orally twice daily for three months
* (Other Name) Silibin-phosphatidylcholine placebo, Siliphos placebo
* (Other Name) NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months
|
NAC Active + Silibin Active
n=16 Participants
N-acetylcysteine active + silibin active Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: silibin 480 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo
N-acetylcysteine active + silibin active: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months
* (Other Name): NAC Dietary Supplement: silibin 480 mg orally twice daily for three months Silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months
* (Other Name): Silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months
|
NAC Active + High-dose Silibin Active
n=14 Participants
N-acetylcysteine active + high-dose silibin active Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: high-dose silibin 960 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos
N-acetylcysteine active + high-dose silibin active: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months
|
|---|---|---|---|---|---|
|
Change From Baseline in Hemoglobin-A1c
|
0.35 percentage
Standard Deviation 0.58
|
-0.18 percentage
Standard Deviation 0.68
|
0.72 percentage
Standard Deviation 2.91
|
0.4 percentage
Standard Deviation 2.19
|
0.2 percentage
Standard Deviation 1.14
|
SECONDARY outcome
Timeframe: Baseline and 3 monthsPopulation: The secondary outcome measures: Urinary alpha-1 microglobulin, inflammatory cytokines and C-C chemokines could not be measured due to lack of research personnel support and change in the PI who didn't have sufficient expertise to assess these measures.
Urinary alpha-1 microglobulin, inflammatory cytokines and C-C chemokines were never measured and analyzed.
Outcome measures
Outcome data not reported
Adverse Events
NAC Placebo + Silibin Placebo
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
NAC Active + Silibin Placebo
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
NAC Placebo + Silibin Active
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
NAC Active + Silibin Active
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
NAC Active + High-dose Silibin Active
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
NAC Placebo + Silibin Placebo
n=16 participants at risk
N-acetylcysteine placebo + silibin placebo Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months Other Name: NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo
N-acetylcysteine placebo + silibin placebo: Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months
|
NAC Active + Silibin Placebo
n=12 participants at risk
N-acetylcysteine active + silibin placebo Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo
N-acetylcysteine active + silibin placebo: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months
|
NAC Placebo + Silibin Active
n=16 participants at risk
N-acetylcysteine placebo + silibin active Dietary Supplement: silibin 480 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months Other Name: NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo
N-acetylcysteine placebo + silibin active: Dietary Supplement: silibin 480 mg orally twice daily for three months
* (Other Name) Silibin-phosphatidylcholine placebo, Siliphos placebo
* (Other Name) NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months
|
NAC Active + Silibin Active
n=16 participants at risk
N-acetylcysteine active + silibin active Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: silibin 480 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo
N-acetylcysteine active + silibin active: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months
* (Other Name): NAC Dietary Supplement: silibin 480 mg orally twice daily for three months Silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months
* (Other Name): Silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months
|
NAC Active + High-dose Silibin Active
n=14 participants at risk
N-acetylcysteine active + high-dose silibin active Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: high-dose silibin 960 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos
N-acetylcysteine active + high-dose silibin active: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months
|
|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/16 • 3 months
|
0.00%
0/12 • 3 months
|
6.2%
1/16 • Number of events 1 • 3 months
|
0.00%
0/16 • 3 months
|
0.00%
0/14 • 3 months
|
|
Cardiac disorders
Chest Pain
|
0.00%
0/16 • 3 months
|
8.3%
1/12 • Number of events 1 • 3 months
|
0.00%
0/16 • 3 months
|
0.00%
0/16 • 3 months
|
0.00%
0/14 • 3 months
|
|
Musculoskeletal and connective tissue disorders
Motor Vehicle Accident
|
6.2%
1/16 • Number of events 1 • 3 months
|
0.00%
0/12 • 3 months
|
0.00%
0/16 • 3 months
|
0.00%
0/16 • 3 months
|
0.00%
0/14 • 3 months
|
|
Musculoskeletal and connective tissue disorders
Osteomyelitis
|
0.00%
0/16 • 3 months
|
0.00%
0/12 • 3 months
|
0.00%
0/16 • 3 months
|
6.2%
1/16 • Number of events 1 • 3 months
|
0.00%
0/14 • 3 months
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/16 • 3 months
|
0.00%
0/12 • 3 months
|
0.00%
0/16 • 3 months
|
0.00%
0/16 • 3 months
|
7.1%
1/14 • 3 months
|
Other adverse events
| Measure |
NAC Placebo + Silibin Placebo
n=16 participants at risk
N-acetylcysteine placebo + silibin placebo Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months Other Name: NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo
N-acetylcysteine placebo + silibin placebo: Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months
|
NAC Active + Silibin Placebo
n=12 participants at risk
N-acetylcysteine active + silibin placebo Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo
N-acetylcysteine active + silibin placebo: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months
|
NAC Placebo + Silibin Active
n=16 participants at risk
N-acetylcysteine placebo + silibin active Dietary Supplement: silibin 480 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months Other Name: NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo
N-acetylcysteine placebo + silibin active: Dietary Supplement: silibin 480 mg orally twice daily for three months
* (Other Name) Silibin-phosphatidylcholine placebo, Siliphos placebo
* (Other Name) NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months
|
NAC Active + Silibin Active
n=16 participants at risk
N-acetylcysteine active + silibin active Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: silibin 480 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo
N-acetylcysteine active + silibin active: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months
* (Other Name): NAC Dietary Supplement: silibin 480 mg orally twice daily for three months Silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months
* (Other Name): Silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months
|
NAC Active + High-dose Silibin Active
n=14 participants at risk
N-acetylcysteine active + high-dose silibin active Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: high-dose silibin 960 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos
N-acetylcysteine active + high-dose silibin active: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Heart burn, nausea, diarrhea, abd pain, anorexia
|
12.5%
2/16 • 3 months
|
33.3%
4/12 • Number of events 4 • 3 months
|
12.5%
2/16 • Number of events 2 • 3 months
|
31.2%
5/16 • Number of events 5 • 3 months
|
28.6%
4/14 • Number of events 6 • 3 months
|
|
General disorders
Congestion, Sore throat, Myalgias
|
6.2%
1/16 • 3 months
|
0.00%
0/12 • 3 months
|
18.8%
3/16 • Number of events 3 • 3 months
|
6.2%
1/16 • Number of events 1 • 3 months
|
7.1%
1/14 • Number of events 1 • 3 months
|
|
General disorders
Infection - soft tissue, UTI
|
12.5%
2/16 • 3 months
|
0.00%
0/12 • 3 months
|
0.00%
0/16 • 3 months
|
0.00%
0/16 • 3 months
|
7.1%
1/14 • Number of events 1 • 3 months
|
|
Nervous system disorders
Vertigo
|
6.2%
1/16 • 3 months
|
0.00%
0/12 • 3 months
|
0.00%
0/16 • 3 months
|
0.00%
0/16 • 3 months
|
0.00%
0/14 • 3 months
|
|
Endocrine disorders
Hypoglycemia
|
6.2%
1/16 • 3 months
|
0.00%
0/12 • 3 months
|
0.00%
0/16 • 3 months
|
0.00%
0/16 • 3 months
|
7.1%
1/14 • Number of events 1 • 3 months
|
|
Renal and urinary disorders
AKI, hyperkalemia, Edema
|
0.00%
0/16 • 3 months
|
16.7%
2/12 • Number of events 3 • 3 months
|
0.00%
0/16 • 3 months
|
6.2%
1/16 • Number of events 1 • 3 months
|
14.3%
2/14 • Number of events 2 • 3 months
|
|
Immune system disorders
Flushing
|
0.00%
0/16 • 3 months
|
8.3%
1/12 • Number of events 1 • 3 months
|
0.00%
0/16 • 3 months
|
0.00%
0/16 • 3 months
|
0.00%
0/14 • 3 months
|
|
Musculoskeletal and connective tissue disorders
Fracture, sprain, stiffness
|
0.00%
0/16 • 3 months
|
0.00%
0/12 • 3 months
|
0.00%
0/16 • 3 months
|
6.2%
1/16 • Number of events 2 • 3 months
|
0.00%
0/14 • 3 months
|
|
Cardiac disorders
Hypotension
|
0.00%
0/16 • 3 months
|
0.00%
0/12 • 3 months
|
6.2%
1/16 • Number of events 1 • 3 months
|
0.00%
0/16 • 3 months
|
0.00%
0/14 • 3 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place