Digestive System DisordersPhase 3AMARGOLNCT01485328
Protocol: Phytomedicine-AMARGOL®, Clinical Trial for Efficacy Proof on Therapeutics
A Phase 3 study testing AMARGOL® in people with Digestive System Disorders, run by Laboratorio Saude Ltda. at 1 site in Brazil.
Trial summary
This is a Phase 3: Efficacy Study for AMARGOL® a phytomedicine used for asymptomatic digestive complaints. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Digestive System Disorders
- What is being tested?
- AMARGOL®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2008to Sep 2009
- Phase
- Phase 3
- 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 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-45 years old
- 65-85 Kg
- healthy volunteers
Who cannot join
- chronic dyspeptics illness chronic congestive cardiac problems
- pulmonary problems
- diabetes, thyroid problems
- pregnancy
- bowel syndrome
- hemorrhoids
- colitis
- allergies for any formula components.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase III - Efficacy Study of AMARGOL - Phytomedicine on Therapeutics
This is a Phase 3: Efficacy Study for AMARGOL® a phytomedicine used for asymptomatic digestive complaints.
Read the detailed description
This study will be performed for proving the efficacy of AMARGOL®, a phytomedicine product, under the Brazilian law for registration and revalidation RDC 14/2010.
AMARGOL® indications are for non specific digestive complaints as laxative and anti-dyspeptic.
Is a mixture of 7 plant extracts: Aloe ferox, Angelica archangelica, Alpinia officinarum, Cinnamomum zeylanicum, Gentiana lutea, Commiphora myrrh and Rheum palmatum.
Placebo controlled test
- Conditions
- Digestive System Disorders
- Being tested
- AMARGOL®
- Keywords
- Dyspepsia, Flatulence, Aerophagia, Constipation
- Medical subject headings
- Digestive System Diseases, Dyspepsia, Flatulence, Aerophagy, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMARGOL®Drug
Also called AMARGOL, Phytomedicine, Herbal Extracts Mixture
per oral solution, 40 mL single dose
| Study group | Role | What they receive |
|---|---|---|
| AMARGOL | Active comparator | per oral solution 40 mL single dose Receives: Drug: AMARGOL® |
| Vehicle without active principles | Placebo comparator | per oral solution 40 mL single dose Receives: Drug: AMARGOL® |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS - visual analogue scale
Single dose 40mL AMARGOL 20 minutes before Dinner - strong meal
Measured: 24h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2011 (estimated)
- Study startDec 2008
- Primary completionApr 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digestive System DisordersStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratorio Saude Ltda.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Phytopharm Consulting Brazil
- Responsible party
- Sponsor
- Investigators
- Angelo G Chaves, Doctor, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01485328
- Sponsor's protocol ID
- labsaude-001-ama
- Acronym
- AMARGOL
- Status last verified
- Dec 2011
- First submitted
- 16 Dec 2008
- Last updated
- 6 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III - Efficacy Study of AMARGOL - Phytomedicine on Therapeutics
- ClinicalTrials.gov ID
- NCT01485328
- Acronym / sponsor ID
- AMARGOL / labsaude-001-ama
- Conditions
- Digestive System Disorders
- Keywords
- Dyspepsia, Flatulence, Aerophagia, Constipation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Laboratorio Saude Ltda.Industry (pharma, biotech, devices)
- Collaborators
- Phytopharm Consulting Brazil
- Study start
- Dec 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 5 Dec 2011 (estimated)
- 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 is a Phase 3: Efficacy Study for AMARGOL® a phytomedicine used for asymptomatic digestive complaints.
Detailed description
This study will be performed for proving the efficacy of AMARGOL®, a phytomedicine product, under the Brazilian law for registration and revalidation RDC 14/2010.
AMARGOL® indications are for non specific digestive complaints as laxative and anti-dyspeptic.
Is a mixture of 7 plant extracts: Aloe ferox, Angelica archangelica, Alpinia officinarum, Cinnamomum zeylanicum, Gentiana lutea, Commiphora myrrh and Rheum palmatum.
Placebo controlled test
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AMARGOL | Active comparator | Drug: AMARGOL®per oral solution 40 mL single dose |
| Vehicle without active principles | Placebo comparator | Drug: AMARGOL®per oral solution 40 mL single dose |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18-45 years old
- 65-85 Kg
- healthy volunteers
Key exclusion criteria (8 listed)
- chronic dyspeptics illness chronic congestive cardiac problems
- pulmonary problems
- diabetes, thyroid problems
- pregnancy
- bowel syndrome
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 |
|---|---|---|
| AMARGOL®Also: AMARGOL, Phytomedicine, Herbal Extracts Mixtureper oral solution, 40 mL single dose | Drug | AMARGOL, Vehicle without active principles |
Primary outcome
VAS - visual analogue scale
Time frame: 24h
Single dose 40mL AMARGOL 20 minutes before Dinner - strong meal
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 6 Dec 2011.
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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.
Angelo G Chaves, Doctor principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AMARGOL® in people with Digestive System Disorders, run by Laboratorio Saude Ltda. at 1 site in Brazil.
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 3 inclusion and 8 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 6 Dec 2011. 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 Brazil. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
VAS - visual analogue scale (time frame: 24h). 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 6 Dec 2011.