HealthyPhase 2NCT03349697
Phyllantus Amarus for the Protection of Liver Health
A Phase 2 study testing Phyllantus amarus in people with Healthy, run by Biotropics Malaysia Berhad at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Phyllantus amarus
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jul 2010to 16 Oct 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- Phyllantus amarus, Placebo
- Keywords
- Liver Health, Hangover, Herbal supplement, Liver function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phyllantus amarusDietary supplement
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Active Product then Placebo | Experimental | Not described Receives: Dietary Supplement: Phyllantus amarus; Other: Placebo |
| Placebo then Active Product | Experimental | Not described Receives: Dietary Supplement: Phyllantus amarus; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the effect of Phyllantus versus placebo on HS CRP levels in blood
Measured: 26 days
Compare the effect of Phyllantus versus placebo on the inflammatory cytokines in blood
Measured: 26 days
Compare the effect of Phyllantus versus placebo on liver function levels in blood
Measured: 26 days
Compare the effect of Phyllantus versus placebo on glutatoine peroxidase (GSH-Px) in blood
Measured: 26 days
Secondary outcomes (4)
Compare the effect of Phyllantus versus placebo on hangover severity score
Measured: 26 days
Compare the effect of Phyllantus versus placebo on profile of mood states (POMS)
Measured: 26 days
Compare the effect of Phyllantus versus placebo on cognitive performance tests
Using the CNS Vital Signs System
Measured: 26 days
Compare the effect of Phyllantus versus placebo on sleep quality
Based on the number of hours slept
Measured: 26 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2017
- Study start13 Jul 2010
- Primary completion16 Oct 2010
- Study completion16 Oct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotropics Malaysia Berhad
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tengku Shahrir Tengku Adnan, Study director, Biotropics Malaysia BerhadSanjay Udani, MD, Principal investigator, Medicus Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03349697
- Sponsor's protocol ID
- BIOT1200
- Status last verified
- Nov 2017
- First submitted
- 17 Nov 2017
- Last updated
- 27 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phyllantus Amarus for the Protection of Liver Health: A Randomized, Double Blind, Placebo Controlled Crossover Study
- ClinicalTrials.gov ID
- NCT03349697
- Acronym / sponsor ID
- BIOT1200
- Conditions
- Healthy
- Keywords
- Liver Health, Hangover, Herbal supplement, Liver function
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Biotropics Malaysia BerhadIndustry (pharma, biotech, devices)
- Study start
- 13 Jul 2010 (actual)
- Primary completion
- 16 Oct 2010 (actual)
- Study completion
- 16 Oct 2010 (actual)
- First posted
- 21 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Product then Placebo | Experimental | Dietary Supplement: Phyllantus amarus, Other: Placebo |
| Placebo then Active Product | Experimental | Dietary Supplement: Phyllantus amarus, Other: Placebo |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phyllantus amarus | Dietary supplement | Active Product then Placebo, Placebo then Active Product |
| Placebo | Other | Active Product then Placebo, Placebo then Active Product |
Primary outcome
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
4 secondary outcomes
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
Compare the effect of Phyllantus versus placebo on sleep quality
Time frame: 26 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tengku Shahrir Tengku Adnan study director
Biotropics Malaysia Berhad
Sanjay Udani, MD principal investigator
Medicus Research, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Phyllantus amarus in people with Healthy, run by Biotropics Malaysia Berhad at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the effect of Phyllantus versus placebo on HS CRP levels in blood (time frame: 26 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2017.