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Trial record 3 of 3 for:    acetylcysteine hangover

Effect of Glutathione on Blood Alcohol and Hangover Symptoms

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: NCT00127309
Recruitment Status : Completed
First Posted : August 5, 2005
Last Update Posted : August 24, 2005
Sponsor:
Collaborator:
T.C Union Global Plc.
Information provided by:
Piyavate Hospital

Tracking Information
First Submitted Date  ICMJE August 4, 2005
First Posted Date  ICMJE August 5, 2005
Last Update Posted Date August 24, 2005
Study Start Date  ICMJE June 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Glutathione on Blood Alcohol and Hangover Symptoms
Official Title  ICMJE Not Provided
Brief Summary

Glutathione (a tripeptide of 3 amino acids - glutamic acid, cysteine and glycine) plays a great role in homeostasis, especially as a potent anti-oxidant.

As an anti-oxidant, it conjugates with xenobiotics using glutathione-S-transferase (GST) and excretes in urine as mercapturic acid.

In 1986, Casciani et al at the University of Milan, studied the effect of glutathione on blood alcohol, acetaldehyde and hepatic triglyceride levels and found a significant reducing effect.

The blood acetaldehyde, which is the metabolic product of ethyl alcohol may have a correlation with hangover symptoms. This study is designed to find this correlation using blood alcohol, blood acetaldehyde levels and the Hangover Symptoms Scale according to the Slutske et al study.

Detailed Description

Type of Study: Double-blinded control

Population: 100 males

Inclusion Criteria:

  • Males 20-40 years
  • Healthy, without chronic diseases, especially must have normal hepatic function, measured by serum SGPT
  • No history of alcoholic allergy
  • Drink alcohol regularly, at least once a week
  • Agree to be a subject by standard consent form

Exclusion Criteria:

  • Subject wants to end the study
  • Some impending danger to subjects

Number of subjects : 100

Methodology

  1. Subjects are recruited;
  2. History taking, physical examination and SGPT are done by M.D.;
  3. 100 subjects are distributed randomly to numbers 1-100;
  4. Factory provides 2 groups of capsules in randomized packets numbered 1 -100; each package contains 3 sub-packages; each sub-package contains 2 capsules of either placebo or 370 mg glutathione capsules. All the three sub-packages will be all placebo or all glutathione. 50 packages are placebo and 50 packages are glutathione;
  5. Subjects are examined as follows:

    • Hour 0: 3 ml of blood taken for blood alcohol and blood acetaldehyde;
    • Hour 0- 1: consume Thai Whisky (40% alcohol) 60 ml with snacks;
    • Hour 1: ml of blood taken for blood alcohol and blood acetaldehyde;
    • Hour 1.30: ml of blood taken for blood alcohol and blood acetaldehyde;
    • Hour 2.30: ml of blood taken for blood alcohol and blood acetaldehyde;
    • Hour 3.30: ml of blood taken for blood alcohol and blood acetaldehyde;
    • Hour 12: ml of blood taken for blood alcohol and blood acetaldehyde, and Alcohol Hangover Symptom evaluation of each subject is done individually.

Using Wendy S. Slutske et al Scale 0-4:

0= no symptom

  1. minimal
  2. some
  3. much
  4. most

Symptoms are

  1. extreme thirst or dehydration
  2. more tired than usual
  3. headache
  4. nausea
  5. vomiting
  6. very weak
  7. difficulty concentrating
  8. more sensitive to light and sound than usual
  9. more sweating than usual
  10. have a lot of trouble sleeping
  11. anxious
  12. depressed
  13. trembling or shaking

Blood alcohol, blood acetaldehyde and hangover symptoms are statistically evaluated for significance.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Alcohol Drinking
Intervention  ICMJE Drug: Glutathione
Study Arms  ICMJE Not Provided
Publications * L. Casciani et al.,Effect of GSH on hepatic triglyceride levels at different times after ethanol intoxification IRSC Med.Sci.,vol.14,158(1986)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: August¬†4,¬†2005)
100
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE August 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy
  • Males 20-40 years old
  • No allergies to alcohol

Exclusion Criteria:

  • Chronic disease
  • Increase in hepatic enzyme SGPT
  • Impending danger
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00127309
Other Study ID Numbers  ICMJE sj_1
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Piyavate Hospital
Collaborators  ICMJE T.C Union Global Plc.
Investigators  ICMJE
Principal Investigator: Staporn Jinaratana, M.D Piyavate Hospital
PRS Account Piyavate Hospital
Verification Date July 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP