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This study is a randomized, double-blind, placebo controlled crossover study. The purpose of this study is to assess the ability of Phyllantus amarus to protect the liver against temporary stress including oxidative stress induced by alcohol consumption.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Product then Placebo | Experimental |
| |
| Placebo then Active Product | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phyllantus amarus | Dietary Supplement |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Compare the effect of Phyllantus versus placebo on HS CRP levels in blood | 26 days | |
| Compare the effect of Phyllantus versus placebo on the inflammatory cytokines in blood | 26 days | |
| Compare the effect of Phyllantus versus placebo on liver function levels in blood | 26 days | |
| Compare the effect of Phyllantus versus placebo on glutatoine peroxidase (GSH-Px) in blood | 26 days |
| Measure | Description | Time Frame |
|---|---|---|
| Compare the effect of Phyllantus versus placebo on hangover severity score | 26 days | |
| Compare the effect of Phyllantus versus placebo on profile of mood states (POMS) | 26 days | |
| Measure | Description | Time Frame |
|---|---|---|
| Compare the effect of Phyllantus versus placebo on adverse events | 36 days | |
| Compare the effect of Phyllantus versus placebo on a comprehensive metabolic panel (CMP) analysis | 26 days | |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tengku Shahrir Tengku Adnan | Biotropics Malaysia Berhad | Study Director |
| Sanjay Udani, MD | Medicus Research, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medicus Research, LLC | Northridge | California | 91325 | United States |
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| Other |
|
| Compare the effect of Phyllantus versus placebo on cognitive performance tests |
Using the CNS Vital Signs System |
| 26 days |
| Compare the effect of Phyllantus versus placebo on sleep quality | Based on the number of hours slept | 26 days |
| Compare the effect of Phyllantus versus placebo on complete blood count |
| 26 days |
| Compare the effect of Phyllantus versus placebo on Urinalaysis | 26 days |