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

December 5, 2011 updated by: Laboratorio Saude Ltda.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • RS
      • Porto Alegre, RS, Brazil, 90130-021
        • Phytopharm Consulting

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 41 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: AMARGOL
per oral solution 40 mL single dose
Drug: AMARGOL®
per oral solution, 40 mL single dose
Other Names:
  • AMARGOL
  • Phytomedicine
  • Herbal Extracts Mixture
Placebo Comparator: Vehicle without active principles
per oral solution 40 mL single dose
Drug: AMARGOL®
per oral solution, 40 mL single dose
Other Names:
  • AMARGOL
  • Phytomedicine
  • Herbal Extracts Mixture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAS - visual analogue scale
Time Frame: 24h
Single dose 40mL AMARGOL 20 minutes before Dinner - strong meal
24h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laboratorio Saude Ltda.

Collaborators

Phytopharm Consulting Brazil

Investigators

  • Principal Investigator: Angelo G Chaves, Doctor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

December 16, 2008

First Submitted That Met QC Criteria

December 2, 2011

First Posted (Estimate)

December 5, 2011

Study Record Updates

Last Update Posted (Estimate)

December 6, 2011

Last Update Submitted That Met QC Criteria

December 5, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • labsaude-001-ama

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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