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Effect of Glutathione on Blood Alcohol and Hangover Symptoms

Primary Purpose

Alcohol Drinking

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Glutathione
Sponsored by
Piyavate Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Drinking focused on measuring hangover, hangover symptoms

Eligibility Criteria

20 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria: Healthy Males 20-40 years old No allergies to alcohol Exclusion Criteria: Chronic disease Increase in hepatic enzyme SGPT Impending danger

Sites / Locations

  • Piyavate Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 4, 2005
Last Updated
August 23, 2005
Sponsor
Piyavate Hospital
Collaborators
T.C Union Global Plc.
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1. Study Identification

Unique Protocol Identification Number
NCT00127309
Brief Title
Effect of Glutathione on Blood Alcohol and Hangover Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
July 2005
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Piyavate Hospital
Collaborators
T.C Union Global Plc.

4. Oversight

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Drinking
Keywords
hangover, hangover symptoms

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
100 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Glutathione

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy Males 20-40 years old No allergies to alcohol Exclusion Criteria: Chronic disease Increase in hepatic enzyme SGPT Impending danger
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Staporn Jinaratana, M.D
Organizational Affiliation
Piyavate Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Piyavate Hospital
City
Bangkok
ZIP/Postal Code
10320
Country
Thailand

12. IPD Sharing Statement

Citations:
Citation
L. Casciani et al.,Effect of GSH on hepatic triglyceride levels at different times after ethanol intoxification IRSC Med.Sci.,vol.14,158(1986)
Results Reference
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Effect of Glutathione on Blood Alcohol and Hangover Symptoms

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