Phyllantus Amarus for the Protection of Liver Health

Phyllantus Amarus for the Protection of Liver Health: A Randomized, Double Blind, Placebo Controlled Crossover Study

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Placebo; Dietary supplement: Phyllantus amarus

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Northridge, California, United States, 91325
      • Medicus Research, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy male or female 21-50 years of age, inclusive.
• Subject consumes at least 5 servings of alcohol per week on a regular basis.
• Minimum POMS score of 15.
• Access to a computer and internet
• 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.
• Body mass index (BMI) between 20 and 30 kg/m2.
• Subject is willing and able to comply with the alcohol consumption requirements.
• Subjects willing to stay in the clinic for two overnight stays
• Judged by the Investigator to be in general good health on the basis of medical history.
• Subject understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study investigator.

Exclusion Criteria:

• Any Liver condition including Hepatitis, Fatty Liver, Liver Disease.
• Liver Function greater than three times the upper level limit of normal
• History or record of aggressive or violent behavior
• Any significant 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, history of upper GI bleed (bleeding ulcer), chronic constipation (defined as <3 bowel movements per week), history of frequent diarrhea, history of surgery for weight loss, gastroparesis, clinically important lactose intolerance].
• Clinically significant renal, hepatic, endocrine (including diabetes mellitus), cardiac, pulmonary, pancreatic, neurologic, or biliary disorder.
• Known allergy or sensitivity to any ingredients in the study products.
• Extreme dietary habits (e.g., vegan, Atkins Diet, etc.).
• Recent (within two weeks of visit 1, week -1) episode of acute gastrointestinal illness such as nausea, vomiting, or diarrhea.
• Uncontrolled hypertension (systolic blood pressure _160 mm Hg or diastolic blood pressure _100 mm Hg at visit 1, week -1).
• History or presence of cancer in the prior two years, except for non-melanoma skin cancer.
• Any major trauma or surgical event within three months of visit 1, week -1.
• Recent use of antibiotics (within 6 weeks).
• Females who are pregnant, lactating, planning to be pregnant during the study period.
• Recent history of (within 12 months) or strong potential for alcohol or substance abuse. Alcohol abuse will be defined as >14 drinks per week (1 drink =12 ounces beer, 5 ounces wine, or 1 ½ ounces distilled spirits).
• Participation in a clinical study with exposure to any non-registered drug product within 30 days prior.
• 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
• Current active respiratory illness at the time of screening
• Any immune system disorders
• Subjects with a history of perforation of the stomach or intestines
• Subjects who have had gastric bypass surgery
• Untreated Hypothyroidism
• Subjects with active eating disorder including anorexia nervosa, bulimia, and/or obsessive compulsive eating disorders
• Spinal cord injuries

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Active Product then Placebo	Other: Placebo; Dietary supplement: Phyllantus amarus
EXPERIMENTAL: Placebo then Active Product	Other: Placebo; Dietary supplement: Phyllantus amarus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Other Outcome Measures

Outcome Measure	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
Compare the effect of Phyllantus versus placebo on complete blood count	26 days
Compare the effect of Phyllantus versus placebo on Urinalaysis	26 days

Collaborators and Investigators

• Sponsor: Biotropics Malaysia Berhad
• Investigators: Study Director: Tengku Shahrir Tengku Adnan, Biotropics Malaysia Berhad; Principal Investigator: Sanjay Udani, MD, Medicus Research, LLC

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 13, 2010
• Primary Completion (ACTUAL): October 16, 2010
• Study Completion (ACTUAL): October 16, 2010

Study Registration Dates

• First Submitted: November 17, 2017
• First Submitted That Met QC Criteria: November 20, 2017
• First Posted (ACTUAL): November 21, 2017

Study Record Updates

• Last Update Posted (ACTUAL): November 27, 2017
• Last Update Submitted That Met QC Criteria: November 22, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Liver function; Herbal supplement; Liver Health; Hangover
• Other Study ID Numbers: BIOT1200

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No