Phyllantus Amarus for the Protection of Liver Health

NCT ID: NCT03349697

Last Updated: 2017-11-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-13
• Study Completion Date: 2010-10-16

Brief Summary

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.

Conditions

Healthy

Keywords

Liver Health; Hangover; Herbal supplement; Liver function

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Active Product then Placebo

Group Type: EXPERIMENTAL

Phyllantus amarus

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Intervention Type: OTHER

Placebo then Active Product

Group Type: EXPERIMENTAL

Phyllantus amarus

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Intervention Type: OTHER

Interventions

Phyllantus amarus

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Biotropics Malaysia Berhad

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tengku Shahrir Tengku Adnan

Role: STUDY_DIRECTOR

Biotropics Malaysia Berhad

Sanjay Udani, MD

Role: PRINCIPAL_INVESTIGATOR

Medicus Research, LLC

Locations

Medicus Research, LLC

Northridge, California, United States

Countries

United States

Other Identifiers

BIOT1200

Identifier Type: -

Identifier Source: org_study_id