Temporary liver stress induced by alcohol consumption Digestive System Alcoholic liver disease, unspecified
Conditions
Interventions
PhyllPro, a propriety extract of Phyllanthus amarus 375 mg to be taken orally, one tablet twice daily for 10 days.
The placebo was a combination of inactive components, including microcrystalline ce
Sponsors
Biotropics Malaysia (Malaysia)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy male or female 21-50 years of age, inclusive 2. Subject consumes at least five servings of alcohol per week on a regular basis. Liquor vs wine or beer 3. Minimum Profile of Mood States (POMS) score of 15 4. Access to a computer and internet 5. Subject is willing to maintain his or her habitual food and beverage intake (other than substitution of study food for similar products) and physical activity patterns throughout the study period 6. Body mass index (BMI) between 20 and 30 kg/m2 7. Subject is willing and able to comply with the alcohol consumption requirements 8. Subjects willing to stay in the clinic for two overnight stays 9. Generally healthy 10. Agree to all visits and study procedures
Exclusion criteria
Exclusion criteria: 1. Any liver condition including hepatitis B, hepatitis C, fatty liver and liver disease 2. Liver function greater than three times the upper level limit of normal 3. History or record of aggressive or violent behavior 4. Evidence of liver disease 5. Presence of ascites 6. Family history of alcoholism 7. Any significant gastrointestinal (GI) condition that would potentially interfere with the evaluation of the study product [e.g.,ulcerative colitis or Crohn?s disease, inflammatory bowel disease, irritable bowel syndrome, clinically significant gastritis, celiac disease, gastroesophageal reflux disease (GERD), history of upper GI bleed (bleeding ulcer), chronic constipation (defined as 14 drinks per week (1 drink =12 ounces beer, 5 ounces wine, or 1 ½ ounces distilled spirits) 19. Participation in a clinical study with exposure to any non-registered drug product within 30 days prior 20. Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk 21. Current active respiratory illness at the time of screening 22. Any immune system disorders 23. Subjects with a history of perforation of the stomach or intestines 24. Subjects who have had gastric bypass surgery 25. Untreated hypothyroidism 26. Subjects with active eating disorder including anorexia nervosa, bulimia, and/or obsessive compulsive eating disorders 27. Spinal cord injuries
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. High Sensitivity C-reactive Protein (HS CRP) 2. Inflammatory Cytokine Panel [including TNF alpha, IL-1Beta, IL-2 , IL-4 , IL-5, IL-6 , IL-7, IL-8, IL-10 , IL-12p70, IL-13 , IL-17A, TNF-alpha , G-CSF , Eotaxin, MIP1Beta, IFNgamma, VEGF, MCP- 1, FGF-BASIC, GM-CSF] 3. Liver function tests [AST and ALT, total bilirubin, albumin, International Normalized ratio (INR), aspartate amino transferase, alanine amino transferase and alkaline phosphatase] | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Hangover severity score: 7-point scale from none (0) to six (6). Healthy subjects should have a score of 0 2. Profile of Mood States (POMS) 3. Cognitive performance tests (CNS Vital Signs System) 4. Sleep Quality Scale | — |
Countries
United States of America
Outcome results
None listed