A clinical study to compare the efficacy and safety of DOTSHOT in the treatment of Hangover of Alcohol
- Registration Number
- CTRI/2017/09/009831
- Lead Sponsor
- K Patel phyto Extraction Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
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
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 Primary Endpoints <br/ ><br>1. Assessment of changes in Biochemical Evaluation from screening to end of the treatment for hangover effects. <br/ ><br>2. The Biochemical parameters includes:- <br/ ><br>a. ALDH (Acetaldehyde Dehydrogenase): Baseline, after 0, 2 hours and 10 hours of the formulation. <br/ ><br>b. Blood Aldehyde: Baseline, after 0, 2 hours and 10 hours of the formulation. <br/ ><br>c. Blood Alcohol: Baseline, after 0, 2 hours and 10 hours of the formulation. <br/ ><br>d. ALT, AST and ALP (baseline, 2 and 10 hours of formulation) <br/ ><br>Timepoint: From Baseline To End of Treatment <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1.Assessment of Changes in the Behaviour from screening to end of the treatment for hangover effects. <br/ ><br>2. Behaviour study based questions: <br/ ><br> <br/ ><br>a. Questionnaire to ask to understand the level of hangover. <br/ ><br>b. Walk test on drawn single line on the floor (15 meters) to understand the level of hangover. <br/ ><br>c. Incidence and rate of adverse events <br/ ><br>Timepoint: From Baseline To End of Treatment