A clinical study to compare the efficacy and safety of DOTSHOT in the treatment of Hangover of Alcohol

Completed

• Conditions: Hangover due to alcohol consumption for occasional drinker

• Registration Number: CTRI/2017/09/009831
• Lead Sponsor: K Patel phyto Extraction Pvt Ltd

Brief Summary

A randomized Double Blind Placebo controlled parallel clinical study to evaluate the Efficacy of Healthdrink DotShot 70 ml in the  treatment of Hangover Due to alcohol Intoxication Total 30 male subject will be enrolled in the study In house study  Duration of the study will not exceed 10 days  To compare the safety and efficacy of Health drink DotShot 125 mg curcumin/ 70 ml and placebo in the treatment of alcohol induced Hang over

Detailed Description

Not available

Study Timeline

• Study Completion: 2017-09-19
• Study Start: 2017-09-21
• Last Update Posted: 2018-12-31

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

• 1. Michigan Alcoholism Screening Test (MAST): more than 2 to 5.
• 2. Willing to provide written informed consent for participation in the study and adhere to the protocol requirements.

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
2. The Biochemical parameters includes:-	From Baseline To End of Treatment
a. ALDH (Acetaldehyde Dehydrogenase): Baseline, after 0, 2 hours and 10 hours of the formulation.	From Baseline To End of Treatment
c. Blood Alcohol: Baseline, after 0, 2 hours and 10 hours of the formulation.	From Baseline To End of Treatment
Primary Endpoints	From Baseline To End of Treatment
1. Assessment of changes in Biochemical Evaluation from screening to end of the treatment for hangover effects.	From Baseline To End of Treatment
b. Blood Aldehyde: Baseline, after 0, 2 hours and 10 hours of the formulation.	From Baseline To End of Treatment
d. ALT, AST and ALP (baseline, 2 and 10 hours of formulation)	From Baseline To End of Treatment

Secondary Outcome Measures

Name	Time	Method
1.Assessment of Changes in the Behaviour from screening to end of the treatment for hangover effects.	2. 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 Indu M Raja

Principal investigator

80-23641042

pi.mail@icbiocro.com