Phyllantus Amarus for the Protection of Liver Health

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03349697
• Other study ID #: BIOT1200
• Status: Completed
• Phase: Phase 2
• First received: November 17, 2017
• Last updated: November 22, 2017
• Start date: July 13, 2010
• Est. completion date: October 16, 2010

Study information

• Verified date: November 2017
• Source: Biotropics Malaysia Berhad
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 16, 2010
• Est. primary completion date: October 16, 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Phyllantus amarus

Other:
• Placebo

Locations

Country	Name	City	State
United States	Medicus Research, LLC	Northridge	California

Sponsors (1)

Lead Sponsor	Collaborator
Biotropics Malaysia Berhad

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Compare the effect of Phyllantus versus placebo on adverse events		36 days
Other	Compare the effect of Phyllantus versus placebo on a comprehensive metabolic panel (CMP) analysis		26 days
Other	Compare the effect of Phyllantus versus placebo on complete blood count		26 days
Other	Compare the effect of Phyllantus versus placebo on Urinalaysis		26 days
Primary	Compare the effect of Phyllantus versus placebo on HS CRP levels in blood		26 days
Primary	Compare the effect of Phyllantus versus placebo on the inflammatory cytokines in blood		26 days
Primary	Compare the effect of Phyllantus versus placebo on liver function levels in blood		26 days
Primary	Compare the effect of Phyllantus versus placebo on glutatoine peroxidase (GSH-Px) in blood		26 days
Secondary	Compare the effect of Phyllantus versus placebo on hangover severity score		26 days
Secondary	Compare the effect of Phyllantus versus placebo on profile of mood states (POMS)		26 days
Secondary	Compare the effect of Phyllantus versus placebo on cognitive performance tests	Using the CNS Vital Signs System	26 days
Secondary	Compare the effect of Phyllantus versus placebo on sleep quality	Based on the number of hours slept	26 days