Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001996257
Ethics application status
Approved
Date submitted
29/11/2018
Date registered
12/12/2018
Date last updated
20/01/2020
Date data sharing statement initially provided
12/12/2018
Date results information initially provided
20/01/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
A study to assess the effects of Rapid Recovery on the adverse effects of alcohol consumption
Scientific title
A double blind randomized placebo controlled crossover study to assess the effects of Rapid Recovery on the adverse after effects of alcohol consumption possibly due to acetaldehyde
Secondary ID [1] 296744 0
Nill
Universal Trial Number (UTN)
UTN 1111-1224-7234
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
hangover 310621 0
Condition category
Condition code
Metabolic and Endocrine 309338 309338 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
750mg once daily
Administration over two days 2 capsules first dose at the end of the consumption of alcohol 2 capsules the second dose the following morning
First dose given at site by site staff.
Second dose recorded by patient time and date and returned to staff the following day
There is a seven day washout period
Each capsule contains l-cysteine hydrochloride 80mg, ascorbic acid 400mg, thiamine hydrochloride 80mg, pyridixine hydrochloride 20mg
Alcohol was consumed 1.3 mg per kilogram for each participant all drinks had the time and amount recorded so that they could be repeated on the following study day
Intervention code [1] 313060 0
Prevention
Comparator / control treatment
Corn flour capsules
Control group
Placebo

Outcomes
Primary outcome [1] 308292 0
Validated questionnaire for Hangover Symptom Severity.
As described by Hogewoning et al overall hangover severity was measured using a single one-item rating and severity of 23 hangover symptoms that was rated on an 11-point Likert scale ranging from 0 to 10. The 23 items were derived from the Alcohol Hangover Severity Scale, the Hangover Symptoms Scale, and the Acute Hangover Scale.

Timepoint [1] 308292 0
all scientific data was collected the day following the alcohol consumption.
Secondary outcome [1] 354552 0
simulated driving ability. This will be assessed using Schuhfried driving/cognitive testing computer. This is a validated assessment of driving ability.
Timepoint [1] 354552 0
one day after the first dose
Secondary outcome [2] 354553 0
High sensitivity C reactive protein and Gamma GT this is a composite secondary outcome looking at these two inflammatory markers. by serum analysis.
Timepoint [2] 354553 0
Baseline, visit 1 and Visit 2

Eligibility
Key inclusion criteria
Normal males and females who have suffered a hangover in the previous year
Minimum age
25 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Have either a drug or alcohol problem or any medical condition that is considered by the Medical practitioner as unsuitable

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomization by an independent pharmacy into sealed numbered envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random computerized number generator
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Paired t-tests

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
10/11/2018
Date of last participant enrolment
Anticipated
22/12/2018
Actual
22/12/2018
Date of last data collection
Anticipated
31/12/2018
Actual
1/06/2019
Sample size
Target
25
Accrual to date
Final
25
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 24973 0
3122 - Hawthorn
Recruitment postcode(s) [2] 24974 0
3122 - Hawthorn North
Recruitment postcode(s) [3] 24975 0
3122 - Hawthorn West

Funding & Sponsors
Funding source category [1] 301324 0
Commercial sector/Industry
Name [1] 301324 0
Phoenix Pharmaceuticals Pty Ltd
Country [1] 301324 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Phoenix Pharmaceuticals Pty Ltd
Address
PO Box 820 Sanctuary Cove
Sanctuary Cove 4212
Queensland
Country
Australia
Secondary sponsor category [1] 300993 0
None
Name [1] 300993 0
Address [1] 300993 0
Country [1] 300993 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302065 0
Swinburne University of Technology Human Ethics Committee
Ethics committee address [1] 302065 0
Swinburne University
John Street
Hawthorn 3221
Victoria
Ethics committee country [1] 302065 0
Australia
Date submitted for ethics approval [1] 302065 0
27/07/2018
Approval date [1] 302065 0
30/07/2018
Ethics approval number [1] 302065 0
SHR Project 2018/275

Summary
Brief summary
The aim of the study is to assess the efficacy of a natural treatment for the symptoms of the adverse after effects f alcohol. The product Rapid Recovery has been developed based on the scientifically supported rationales using several methods of reducing acetaldehyde ( a major metabolite of alcohol) toxicity which is believed to be a major mediator in the adverse after effects of alcohol consumption. Adverse effects of alcohol consumption will be measured the following day using visual analog scales of validated symptoms. In addition blood alcohol concentrations will be measured prior to commencing the study and at the end of the evening drinking and immediately prior to undertaking visual analog scales. Blood sampling will be performed on the first night of the trial and then on the morning after alcohol has been consumed. There have been reports that that there may be an inflammatory response due to acetaldehyde toxicity.
Trial website
none
Trial related presentations / publications
none
Public notes
none

Contacts
Principal investigator
Name 89006 0
Dr Sarah Benson
Address 89006 0
Swinburne University
John Street
Hawthorn 3221
Victoria
Country 89006 0
Australia
Phone 89006 0
+61 03 9214 8000
Fax 89006 0
Email 89006 0
[email protected]
Contact person for public queries
Name 89007 0
Dr Sarah Benson
Address 89007 0
Swinburne University
John Street
Hawthorn 3221
Victoria
Country 89007 0
Australia
Phone 89007 0
+61 03 9214 8000
Fax 89007 0
Email 89007 0
[email protected]
Contact person for scientific queries
Name 89008 0
Dr Sarah Benson
Address 89008 0
Swinburne University
John Street
Hawthorn 3221
Victoria
Country 89008 0
Australia
Phone 89008 0
+61 039241 8000
Fax 89008 0
Email 89008 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This will be discussed with the PI


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffects of rapid recovery on alcohol hangover severity: A double-blind, placebo-controlled, randomized, balanced crossover trial.2020https://dx.doi.org/10.3390/jcm9072175
N.B. These documents automatically identified may not have been verified by the study sponsor.