Hyperbaric Oxygenation in Treatment of Alcohol Dependence Syndrome
1 other identifier
interventional
30
0 countries
N/A
Brief Summary
A 30 alcohol dependent patients were divided into A: Treatment group and B: Placebo group using simple randomization technique. (Liver function tests) GGT, ALT and AST levels and MCV (Mean corpuscular volume) at admission and 2 weeks later were estimated. Daily withdrawal symptoms were assessed using the Clinical Institute Withdrawal Assessment scale (CIWA-Ar) and DTs by Delirium Observation Screening (DOS) Scale (version 0 - 1). The data collected from the two groups were compared.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2014
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedFirst Submitted
Initial submission to the registry
March 2, 2017
CompletedFirst Posted
Study publicly available on registry
March 19, 2018
CompletedMarch 19, 2018
March 1, 2018
5 months
March 2, 2017
March 12, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Rate of improvement
faster recovery from DTs and withdrawal symptoms.
1 year
Study Arms (2)
Hyperbaric Oxygen Therapy
EXPERIMENTALReceived the Hyperbaric Oxygen therapy treatment at 2.4 ATA for 90 minutes each day.
Placebo group
PLACEBO COMPARATORwere also taken inside the Hyperbaric Chamber, but received only normobaric oxygen therapy for the same period of time at 1 ATA
Interventions
Received the Hyperbaric Oxygen therapy treatment at 2.4 ATA for 90 minutes each day.
Received the Normobaric Oxygen therapy treatment at 1 ATA for 90 minutes each day.
Eligibility Criteria
You may qualify if:
- Male patients aged between 20-60 years with alcohol dependence as per ICD-10 criteria, who presented with AWS and DTs on admission or during the course in our ward were recruited to the study.
You may not qualify if:
- Those patients suffering from severe physical illness incapacitating for psychiatric evaluation, who are mentally retarded, who have primary psychiatric disorders like psychosis, mood disorder and those with neurodegenerative disorders like Dementia, Cerebrovascular accidents were excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (4)
Sassi,F.(ed.), Tackling Harmful Alcohol Use: Economics and Public Health Policy, OECD Publishing, Paris 2015.
BACKGROUNDWorld Health Organization (WHO) -Global Status report on Alcohol and Health -2014
BACKGROUNDAmerican psychiatric association; Diagnostic and statistical manual of mental disorders; 4th edition; Text Revision (DSM IV TR)
BACKGROUNDCaetano R, Clark CL, Greenfield TK. Prevalence, trends, and incidence of alcohol withdrawal symptoms: analysis of general population and clinical samples. Alcohol Health Res World. 1998;22(1):73-9.
PMID: 15706737BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor, Department of Psychiatry
Study Record Dates
First Submitted
March 2, 2017
First Posted
March 19, 2018
Study Start
November 1, 2014
Primary Completion
April 1, 2015
Study Completion
April 1, 2016
Last Updated
March 19, 2018
Record last verified: 2018-03
Data Sharing
- IPD Sharing
- Will not share