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N-Acetylcysteine and Milk Thistle for Treatment of Diabetic Nephropathy (CGDN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01265563
Recruitment Status : Completed
First Posted : December 23, 2010
Results First Posted : March 31, 2017
Last Update Posted : October 19, 2018
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Diabetic Nephropathy
Proteinuria
Oxidative Stress
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
Enrollment 108
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title NAC Placebo + Silibin Placebo NAC Active + Silibin Placebo NAC Placebo + Silibin Active NAC Active + Silibin Active NAC Active + High Dose Silibin Active
Hide Arm/Group Description

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

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

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

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

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

Period Title: Overall Study
Started 16 13 17 16 16
Completed 16 12 16 16 14
Not Completed 0 1 1 0 2
Reason Not Completed
Withdrawal by Subject             0             1             1             0             2
Arm/Group Title NAC Placebo and Silibin Placebo NAC Active and Silibin Placebo NAC Placebo and Silibin Active NAC Active and Silibin Active NAC Active and High-dose Silibin Active Total
Hide Arm/Group Description

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

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

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

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

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 of all reporting groups
Overall Number of Baseline Participants 16 13 17 16 16 78
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Mean (Standard Deviation)
Unit of measure:  Years
Age Number Analyzed 16 participants 13 participants 17 participants 16 participants 16 participants 78 participants
65.3  (5.74) 64  (6.4) 61.9  (8.39) 64.81  (8.113) 59.56  (7.78) 63.09  (7.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 13 participants 17 participants 16 participants 16 participants 78 participants
Female
1
   6.3%
2
  15.4%
0
   0.0%
2
  12.5%
2
  12.5%
7
   9.0%
Male
15
  93.8%
11
  84.6%
17
 100.0%
14
  87.5%
14
  87.5%
71
  91.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 13 participants 17 participants 16 participants 16 participants 78 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
1
   5.9%
0
   0.0%
0
   0.0%
1
   1.3%
Black or African American
1
   6.3%
1
   7.7%
1
   5.9%
1
   6.3%
1
   6.3%
5
   6.4%
White
15
  93.8%
12
  92.3%
15
  88.2%
14
  87.5%
15
  93.8%
71
  91.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1
   6.3%
0
   0.0%
1
   1.3%
BMI  
Mean (Standard Deviation)
Unit of measure:  kg/M^2
Number Analyzed 16 participants 13 participants 17 participants 16 participants 16 participants 78 participants
30.21  (9.28) 39.9  (9.17) 35.86  (8.63) 35.65  (5.16) 35.72  (7.5) 35.31  (7.67)
Systolic BP  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 16 participants 13 participants 17 participants 16 participants 16 participants 78 participants
138.5  (21.76) 125.54  (22.77) 147.41  (16.8) 137.13  (17.10) 142.8  (12) 139.15  (19.02)
Diastolic BP  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 16 participants 13 participants 17 participants 16 participants 16 participants 78 participants
70.44  (15.83) 62.71  (12.63) 77.47  (9.53) 70.88  (8.37) 74.25  (9.61) 71.93  (12.08)
1.Primary Outcome
Title Change From Baseline in Urinary Albumin Excretion
Hide Description Urine albumin to creatinine ratio was assessed at the end of run in period and after 3 months administration of study intervention.
Time Frame Baseline and 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NAC Placebo + Silibin Placebo NAC Active + Silibin Placebo NAC Placebo + Silibin Active NAC Active + Silibin Active NAC Active + High-dose Silibin Active
Hide Arm/Group Description:

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

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

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

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

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 Number of Participants Analyzed 16 12 16 16 14
Mean (Standard Deviation)
Unit of Measure: mg/g
50.5  (291.2) -28.13  (578.32) -4.5  (541) 96.6  (422.4) 353.71  (732.67)
2.Secondary Outcome
Title Change From Baseline in Hemoglobin-A1c
Hide Description Hemoglobin 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
Time Frame Baseline and 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NAC Placebo + Silibin Placebo NAC Active + Silibin Placebo NAC Placebo + Silibin Active NAC Active + Silibin Active NAC Active + High-dose Silibin Active
Hide Arm/Group Description:

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

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

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

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

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 Number of Participants Analyzed 16 12 16 16 14
Mean (Standard Deviation)
Unit of Measure: percentage
0.35  (0.58) -0.18  (0.68) 0.72  (2.91) 0.4  (2.19) 0.2  (1.14)
3.Secondary Outcome
Title Urinary Alpha-1 Microglobulin, Inflammatory Cytokines and C-C Chemokines
Hide Description Urinary alpha-1 microglobulin, inflammatory cytokines and C-C chemokines were never measured and analyzed.
Time Frame Baseline and 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title NAC Placebo and Silibin Placebo NAC Active and Silibin Placebo NAC Placebo and Silibin Active NAC Active and Silibin Active NAC Active and High-dose Silibin Active
Hide Arm/Group Description:

Drug: N-acetylcysteine placebo and Drug: Silibin placebo

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

Drug: N-acetylcysteine and Drug: Silibin placebo

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

Drug: N-acetylcysteine placebo and Drug: Silibin active

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

Drug: N-acetylcysteine active and Drug: Silibin active

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

Drug: N-acetylcysteine active and Drug: Silibin higher dose active

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

Overall Number of Participants Analyzed 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 3 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title NAC Placebo + Silibin Placebo NAC Active + Silibin Placebo NAC Placebo + Silibin Active NAC Active + Silibin Active NAC Active + High-dose Silibin Active
Hide Arm/Group Description

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

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

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

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

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

All-Cause Mortality
NAC Placebo + Silibin Placebo NAC Active + Silibin Placebo NAC Placebo + Silibin Active NAC Active + Silibin Active NAC Active + High-dose Silibin Active
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)      0/12 (0.00%)      0/16 (0.00%)      0/16 (0.00%)      0/14 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
NAC Placebo + Silibin Placebo NAC Active + Silibin Placebo NAC Placebo + Silibin Active NAC Active + Silibin Active NAC Active + High-dose Silibin Active
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/16 (6.25%)      1/12 (8.33%)      1/16 (6.25%)      1/16 (6.25%)      1/14 (7.14%)    
Cardiac disorders           
Chest Pain *  0/16 (0.00%)  1/12 (8.33%)  1 0/16 (0.00%)  0/16 (0.00%)  0/14 (0.00%) 
Bradycardia *  0/16 (0.00%)  0/12 (0.00%)  0/16 (0.00%)  0/16 (0.00%)  1/14 (7.14%) 
Musculoskeletal and connective tissue disorders           
Motor Vehicle Accident *  1/16 (6.25%)  1 0/12 (0.00%)  0/16 (0.00%)  0/16 (0.00%)  0/14 (0.00%) 
Osteomyelitis   0/16 (0.00%)  0/12 (0.00%)  0/16 (0.00%)  1/16 (6.25%)  1 0/14 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Wheezing *  0/16 (0.00%)  0/12 (0.00%)  1/16 (6.25%)  1 0/16 (0.00%)  0/14 (0.00%) 
*
Indicates events were collected by non-systematic assessment
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
NAC Placebo + Silibin Placebo NAC Active + Silibin Placebo NAC Placebo + Silibin Active NAC Active + Silibin Active NAC Active + High-dose Silibin Active
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/16 (43.75%)      7/12 (58.33%)      6/16 (37.50%)      8/16 (50.00%)      9/14 (64.29%)    
Cardiac disorders           
Hypotension *  0/16 (0.00%)  0/12 (0.00%)  1/16 (6.25%)  1 0/16 (0.00%)  0/14 (0.00%) 
Endocrine disorders           
Hypoglycemia *  1/16 (6.25%)  0/12 (0.00%)  0/16 (0.00%)  0/16 (0.00%)  1/14 (7.14%)  1
Gastrointestinal disorders           
Heart burn, nausea, diarrhea, abd pain, anorexia   2/16 (12.50%)  4/12 (33.33%)  4 2/16 (12.50%)  2 5/16 (31.25%)  5 4/14 (28.57%)  6
General disorders           
Congestion, Sore throat, Myalgias   1/16 (6.25%)  0/12 (0.00%)  3/16 (18.75%)  3 1/16 (6.25%)  1 1/14 (7.14%)  1
Infection - soft tissue, UTI   2/16 (12.50%)  0/12 (0.00%)  0/16 (0.00%)  0/16 (0.00%)  1/14 (7.14%)  1
Immune system disorders           
Flushing *  0/16 (0.00%)  1/12 (8.33%)  1 0/16 (0.00%)  0/16 (0.00%)  0/14 (0.00%) 
Musculoskeletal and connective tissue disorders           
Fracture, sprain, stiffness *  0/16 (0.00%)  0/12 (0.00%)  0/16 (0.00%)  1/16 (6.25%)  2 0/14 (0.00%) 
Nervous system disorders           
Vertigo   1/16 (6.25%)  0/12 (0.00%)  0/16 (0.00%)  0/16 (0.00%)  0/14 (0.00%) 
Renal and urinary disorders           
AKI, hyperkalemia, Edema   0/16 (0.00%)  2/12 (16.67%)  3 0/16 (0.00%)  1/16 (6.25%)  1 2/14 (14.29%)  2
*
Indicates events were collected by non-systematic assessment
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Shweta Bansal
Organization: VA- STVHCS
Phone: 2105674700
Publications of Results:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01265563     History of Changes
Other Study ID Numbers: CLIN-004-10S
1R21AT004490-01A1 ( U.S. NIH Grant/Contract )
VA 1I01CX000264-01A2 ( Registry Identifier: VA )
First Submitted: December 10, 2010
First Posted: December 23, 2010
Results First Submitted: January 27, 2017
Results First Posted: March 31, 2017
Last Update Posted: October 19, 2018