Phyllantus Amarus for the Protection of Liver Health

NCT03349697 | Completed Phase 2

• 1 other identifier: BIOT1200
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• 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

  26 days

• Compare the effect of Phyllantus versus placebo on sleep quality

  26 days

Other Outcomes (4)

• 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

Study Arms (2)

Active Product then Placebo

EXPERIMENTAL

Dietary Supplement: Phyllantus amarus; Other: Placebo

Placebo then Active Product

EXPERIMENTAL

Dietary Supplement: Phyllantus amarus; Other: Placebo

Interventions

Phyllantus amarus DIETARY_SUPPLEMENT

Active Product then Placebo; Placebo then Active Product

Placebo OTHER

Active Product then Placebo; Placebo then Active Product

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biotropics Malaysia Berhad: lead

Study Sites (1)

Medicus Research, LLC

Northridge, California, 91325, United States

Location

Study Officials

• Tengku Shahrir Tengku Adnan

  Biotropics Malaysia Berhad

  STUDY DIRECTOR

• Sanjay Udani, MD

  Medicus Research, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2017
• First Posted: November 21, 2017
• Study Start: July 13, 2010
• Primary Completion: October 16, 2010
• Study Completion: October 16, 2010
• Last Updated: November 27, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)