Alcohol DrinkingNCT00127309
Effect of Glutathione on Blood Alcohol and Hangover Symptoms
A study testing Glutathione in people with Alcohol Drinking, run by Piyavate Hospital at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Alcohol Drinking
- What is being tested?
- Glutathione
- How many people
- 100 participants
- Where
- 1 siteThailand
- Study dates
- Jun 2005to Aug 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
- Males 20-40 years old
- No allergies to alcohol
Who cannot join
- Chronic disease
- Increase in hepatic enzyme SGPT
- Impending danger
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Alcohol Drinking
- Being tested
- Glutathione
- Keywords
- hangover, hangover symptoms
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlutathioneDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2005 (estimated)
- Study startJun 2005
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol DrinkingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- Piyavate Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- T.C Union Global Plc.
- Investigators
- Staporn Jinaratana, M.D, Principal investigator, Piyavate Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00127309
- Sponsor's protocol ID
- sj_1
- Status last verified
- Jul 2005
- First submitted
- 4 Aug 2005
- Last updated
- 24 Aug 2005
- Results posted
- No
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)
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Glutathione on Blood Alcohol and Hangover Symptoms
- ClinicalTrials.gov ID
- NCT00127309
- Acronym / sponsor ID
- sj_1
- Conditions
- Alcohol Drinking
- Keywords
- hangover, hangover symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- Piyavate HospitalUniversity, hospital or other
- Collaborators
- T.C Union Global Plc.
- Study start
- Jun 2005
- Study completion
- Aug 2005
- First posted
- 5 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy
- Males 20-40 years old
- No allergies to alcohol
Key exclusion criteria (3 listed)
- Chronic disease
- Increase in hepatic enzyme SGPT
- Impending danger
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glutathione | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2005.
- BackgroundL. Casciani et al.,Effect of GSH on hepatic triglyceride levels at different times after ethanol intoxification IRSC Med.Sci.,vol.14,158(1986)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Staporn Jinaratana, M.D principal investigator
Piyavate Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glutathione in people with Alcohol Drinking, run by Piyavate Hospital at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00127309, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2005.