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Trial record 3 of 259603 for:    ALL

Phyllantus Amarus for the Protection of Liver Health

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03349697
First Posted: November 21, 2017
Last Update Posted: November 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Biotropics Malaysia Berhad
  Purpose
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.

Condition Intervention Phase
Healthy Dietary Supplement: Phyllantus amarus Other: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Phyllantus Amarus for the Protection of Liver Health: A Randomized, Double Blind, Placebo Controlled Crossover Study

Further study details as provided by Biotropics Malaysia Berhad:

Primary Outcome Measures:
  • Compare the effect of Phyllantus versus placebo on HS CRP levels in blood [ Time Frame: 26 days ]
  • Compare the effect of Phyllantus versus placebo on the inflammatory cytokines in blood [ Time Frame: 26 days ]
  • Compare the effect of Phyllantus versus placebo on liver function levels in blood [ Time Frame: 26 days ]
  • Compare the effect of Phyllantus versus placebo on glutatoine peroxidase (GSH-Px) in blood [ Time Frame: 26 days ]

Secondary Outcome Measures:
  • Compare the effect of Phyllantus versus placebo on hangover severity score [ Time Frame: 26 days ]
  • Compare the effect of Phyllantus versus placebo on profile of mood states (POMS) [ Time Frame: 26 days ]
  • Compare the effect of Phyllantus versus placebo on cognitive performance tests [ Time Frame: 26 days ]
    Using the CNS Vital Signs System

  • Compare the effect of Phyllantus versus placebo on sleep quality [ Time Frame: 26 days ]
    Using a sleep quality scale


Other Outcome Measures:
  • Compare the effect of Phyllantus versus placebo on adverse events [ Time Frame: 36 days ]
  • Compare the effect of Phyllantus versus placebo on a comprehensive metabolic panel (CMP) analysis [ Time Frame: 26 days ]
  • Compare the effect of Phyllantus versus placebo on complete blood count [ Time Frame: 26 days ]
  • Compare the effect of Phyllantus versus placebo on Urinalaysis [ Time Frame: 26 days ]

Enrollment: 15
Actual Study Start Date: July 13, 2010
Study Completion Date: October 16, 2010
Primary Completion Date: October 16, 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active Product then Placebo Dietary Supplement: Phyllantus amarus Other: Placebo
Experimental: Placebo then Active Product Dietary Supplement: Phyllantus amarus Other: Placebo

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03349697


Locations
United States, California
Medicus Research, LLC
Northridge, California, United States, 91325
Sponsors and Collaborators
Biotropics Malaysia Berhad
Investigators
Study Director: Tengku Shahrir Tengku Adnan Biotropics Malaysia Berhad
Principal Investigator: Sanjay Udani, MD Medicus Research, LLC
  More Information

Responsible Party: Biotropics Malaysia Berhad
ClinicalTrials.gov Identifier: NCT03349697     History of Changes
Other Study ID Numbers: BIOT1200
First Submitted: November 17, 2017
First Posted: November 21, 2017
Last Update Posted: November 21, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Biotropics Malaysia Berhad:
Liver Health
Hangover
Herbal supplement
Liver function