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

A Randomized Double Blind placebo controlled parallel clinical study to evaluate the efficacy and safety of DOTSHOT in the treatment of Hangover due to alcohol intoxication

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/09/009831
Enrollment
30
Registered
2017-09-19
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: DOTSHOT oral liquid: Curcumin extract of turmeric Oral liquid 70 ml of Health drink of DOTSHOT 30 minutes after last drink. Control Intervention1: Placebo(without active constituents)

Sponsors

K Patel phyto Extraction Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Secondary

MeasureTime frame
1.Assessment of Changes in the Behaviour from screening to end of the treatment for hangover effects. 2. Behaviour study based questions: a. Questionnaire to ask to understand the level of hangover. b. Walk test on drawn single line on the floor (15 meters) to understand the level of hangover. c. 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.com9900111997

Outcome results

None listed

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