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

This study has been completed.
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01265563
First received: December 10, 2010
Last updated: March 31, 2017
Last verified: March 2017
Results First Received: January 27, 2017  
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

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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


Participant Flow:   Overall Study
    NAC Placebo + Silibin Placebo   NAC Active + Silibin Placebo   NAC Placebo + Silibin Active   NAC Active + Silibin Active   NAC Active + High Dose Silibin Active
STARTED   16   13   17   16   16 
COMPLETED   16   12   16   16   14 
NOT COMPLETED   0   1   1   0   2 
Withdrawal by Subject                0                1                1                0                2 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
NAC Placebo and 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 and 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 and 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 and 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 and 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

Total Total of all reporting groups

Baseline Measures
   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 
Overall Participants Analyzed 
[Units: Participants]
 16   13   17   16   16   78 
Age, Customized 
[Units: Years]
Mean (Standard Deviation)
           
Age   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 
[Units: Participants]
Count of 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) 
[Units: Participants]
Count of 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 
[Units: kg/M^2]
Mean (Standard Deviation)
 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 
[Units: mmHg]
Mean (Standard Deviation)
 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 
[Units: mmHg]
Mean (Standard Deviation)
 70.44  (15.83)   62.71  (12.63)   77.47  (9.53)   70.88  (8.37)   74.25  (9.61)   71.93  (12.08) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Urinary Albumin Excretion   [ Time Frame: Baseline and 3 months ]

2.  Secondary:   Change From Baseline in Hemoglobin-A1c   [ Time Frame: Baseline and 3 months ]

3.  Secondary:   Urinary Alpha-1 Microglobulin, Inflammatory Cytokines and C-C Chemokines   [ Time Frame: Baseline and 3 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

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
e-mail: bansals3@uthscsa.edu


Publications of Results:

Other Publications:

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 )
Study First Received: December 10, 2010
Results First Received: January 27, 2017
Last Updated: March 31, 2017