CTRI/2021/03/032236Not yet recruitingPhase 1/2
A double-blind randomised placebo-controlled study followed by an Open-label extension, comparative clinical study to evaluate the effect of PartySmart variants
The Himalaya Drug Company1 site in 1 country30 target enrollmentStarted: March 30, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1/2
- Status
- Not yet recruiting
- Sponsor
- The Himalaya Drug Company
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- 3.Assessment of Alcohol Hangover Questionnaire (AHQ)
Study Overview
Brief Summary
Alcoholhangover develops when the blood alcohol concentration (BAC) returns to zeroand is characterized by a feeling of general misery that may last for more than24 hours. Several factors are known to be involved including acetaldehydeaccumulation, changes in immune system and glucose metabolism, dehydration.Hangover is suggested to be early stage of alcohol withdrawal.
The rational of study to evaluate the effect ofpolyherbal formulations PartySmart variants on alcohol hangover, in correlationwith Blood levels of alcohol and acetaldehyde in normal healthy Volunteers
Study Design
- Study Type
- Interventional
- Allocation
- Other
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 20.00 Year(s) to 45.00 Year(s) (—)
- Sex
- Male
Inclusion Criteria
- •1.Males aged between 20-45 years, weighing more than 45 kgs 2Subject who used to drink alcohol regularly (social drink not alcohol abuse) and is willing and able to comply with the alcohol consumption requirements and overnight stay as per the study requirements 3.Subjects judged by the Investigator to be in general good health based on medical history.
- •4.Subject understands the study procedures and signs the consent forms providing informed consent to participate in the study.
Exclusion Criteria
- •1.Subject suspected for drug or alcohol abuse 2.A medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation 3.Subjective sleep duration of less than 3 hours in the night before the test 4.Caffeine, nicotine or alcohol on the day (from midnight) of the test 5.Use of psycho-active drugs during the past 30 days or any treatment that might interfere with the evaluation of the test drug 6.Any drug known to interact with benzodiazepines and related drugs, e.g. antiepileptics, antihistaminics, muscle relaxant drugs, antihypertensive drugs, drugs inhibiting cytochrome P450 7.Any clinically significant disorder that might interfere with his/her participation in this study and the evaluation of the efficacy or safety of the test drug (e.g. renal insufficiency, hepatic or metabolic dysfunction, cardiovascular disease, neurological and or psychiatric disorder etc.) 8.Known hypersensitivity to any of the ingredients of the study drugs 9.Participation in any other clinical trial within the past 30 days.
Outcomes
Primary Outcomes
3.Assessment of Alcohol Hangover Questionnaire (AHQ)
Time Frame: 12 hours
1.Change in the blood alcohol and acetaldehyde levels
Time Frame: 12 hours
2.Clinical symptoms related to alcohol consumption
Time Frame: 12 hours
Secondary Outcomes
- Incidence of adverse effects.
Investigators
Study Sites (1)
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