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Clinical study to evaluate the efficacy and safety of PARTY ZEST AHO liquid for the prevention of hangover due to alcohol intoxication

A randomized double blind placebo controlled parallel clinical study to evaluate the efficacy and safety of PARTY ZESTAHO liquid Curcumin for the prevention of hangover due to alcohol intoxication - ICBio-CR-ZNPL-0906-97

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/10/021812
Enrollment
60
Registered
2019-10-29
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: PARTY ZEST AHO-liquid 75 ml275 mg of herbal actives per drinkoral liquid: Dosing will be done before initiation of drinking (30 min) for 30 subjects (either test or placebo based on ran

Sponsors

Zystus Nutraceuticals Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 Healthy male 2 Age 25-45 years have the willingness to undergo alcohol drinking 3 Michigan Alcoholism Screening Test more than 2 to 5 (Attachment no.1) 4 Willing to provide written informed consent for participation in the study and adhere to the protocol requirements

Exclusion criteria

Exclusion criteria: 1 A medical history of significant hypersensitivity or allergic reaction to turmeric or related products 2 Volunteers have history of alcohol toxicity like liver cirrhosis neurological disease peptic disease diabetes drug abuse 3 Volunteers have undergone any concomitant medications like antibiotics, anticoagulants, tricyclic antidepressant, cardiovascular medication, sedative, hypnotics. Prior to 14 days 4 History of bile duct obstruction or Cysts of the common bile duct 5 If they have hypersensitivity for alcohol ingestion 6 If they have habit of smoking or tobacco chewing

Design outcomes

Primary

MeasureTime frame
Assessment of changes in Biochemical Evaluation of the prevention for hangover effects for both the groups The Biochemical parameters includes 1.ALDH (Acetaldehyde Dehydrogenase) Baseline after 0, 2 hours and 10 hours of the formulation 2.Blood Aldehyde Baseline, after 0, 2 hours and 10 hours of the formulation 3.Blood Alcohol Baseline, after 0, 2 hours and 10 hours of the formulation. 4.ALT, AST and ALP (baseline, 2 and 10 hours of formulation) Timepoint: From baseline to end of treatment—

Secondary

MeasureTime frame
Assessment of Changes in the Behaviour of the prevention for hangover effects for both the groups Behaviour study based questions 1 Questionnaire to ask to understand the level of hangover (Attachment no. 2) 2 Walk test on drawn single line on the floor (15 meters) to understand the level of hangover (Attachment no. 3) Incidence and rate of adverse events Timepoint: From baseline to end of treatment—

Countries

India

Contacts

Public ContactDr Harisha S

ICBio Clinical Research Pvt. Ltd

harish@icbiocro.com09900111997

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026