MedDataX Logo

Protocol: Phytomedicine-AMARGOL®, Clinical Trial for Efficacy Proof on Therapeutics

NCT ID: NCT01485328

Last Updated: 2011-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2009-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a Phase 3: Efficacy Study for AMARGOL® a phytomedicine used for asymptomatic digestive complaints.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Digestive System Disorders

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Dyspepsia Flatulence Aerophagia Constipation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

AMARGOL

per oral solution 40 mL single dose

Group Type ACTIVE_COMPARATOR

AMARGOL®

Intervention Type DRUG

per oral solution, 40 mL single dose

Vehicle without active principles

per oral solution 40 mL single dose

Group Type PLACEBO_COMPARATOR

AMARGOL®

Intervention Type DRUG

per oral solution, 40 mL single dose

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

AMARGOL®

per oral solution, 40 mL single dose

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

AMARGOL Phytomedicine Herbal Extracts Mixture

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 18-45 years old
* 65-85 Kg
* healthy volunteers

Exclusion Criteria

* chronic dyspeptics illness chronic congestive cardiac problems
* pulmonary problems
* diabetes, thyroid problems
* pregnancy
* bowel syndrome
* hemorrhoids
* colitis
* allergies for any formula components.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Phytopharm Consulting Brazil

NETWORK

Sponsor Role collaborator

Laboratorio Saude Ltda.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Angelo G Chaves, Doctor

Role: PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Phytopharm Consulting

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Brazil

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

labsaude-001-ama

Identifier Type: -

Identifier Source: org_study_id