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OpenTrials
Completed

NCT Number: NCT00127309

Effect of Glutathione on Blood Alcohol and Hangover Symptoms

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.

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Key information

Age range

20 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Piyavate Hospital

Bangkok, 10320, Thailand

About this study

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

  • Subjects are recruited;
  • History taking, physical examination and SGPT are done by M.D.;
  • 100 subjects are distributed randomly to numbers 1-100;
  • 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;
  • 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

  • minimal
  • some
  • much
  • most

Symptoms are

  • extreme thirst or dehydration
  • more tired than usual
  • headache
  • nausea
  • vomiting
  • very weak
  • difficulty concentrating
  • more sensitive to light and sound than usual
  • more sweating than usual
  • have a lot of trouble sleeping
  • anxious
  • depressed
  • trembling or shaking

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Chronic disease
  • Increase in hepatic enzyme SGPT
  • Impending danger

Treatment and study plan

Glutathione

Drug

Sponsors and collaborators

Lead sponsor

Piyavate Hospital

Other

Collaborators

  • T.C Union Global Plc.

Registry information

Important dates

Study start
2005
Study completion
2005
First posted
Aug 5, 2005
Registry last updated
Aug 24, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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