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

Completed

• Conditions: Hangover

• Registration Number: CTRI/2019/10/021812
• Lead Sponsor: Zystus Nutraceuticals Pvt Ltd

Brief Summary

A randomized double blind placebo controlled parallel clinical study to evaluate the efficacy and safety of PARTY ZEST AHO-liquid (Curcumin)for the prevention of hangover due to alcohol intoxication.

Total Sixty(60) Healthy male subjects was enrolled in the study

**In house study**

**Duration of study was not  exceed 10 days.**

To Compare the safety and efficacy of Health drink PARTY ZESTAHO-liquid 275 mg of herbal actives per drink and PLACEBO for the prevention of alcohol induced hangover.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-11
• Study Completion: 2019-11-23
• Last Update Posted: 2020-05-19

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 60

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

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Assessment of Changes in the Behaviour of the prevention for hangover effects for both the groups	Behaviour study based questions

Trial Locations

Locations (1)

ICBio Clinical Research Pvt Ltd; 🇮🇳 Bangalore, KARNATAKA, India

ICBio Clinical Research Pvt Ltd

🇮🇳Bangalore, KARNATAKA, India

Dr Harisha S

Principal investigator

09900111997

harish@icbiocro.com