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

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ClinicalTrials.gov Identifier: NCT01485328
Recruitment Status : Completed
First Posted : December 5, 2011
Last Update Posted : December 6, 2011
Sponsor:
Collaborator:
Phytopharm Consulting Brazil
Information provided by (Responsible Party):
Laboratorio Saude Ltda.

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

Condition or disease Intervention/treatment Phase
Digestive System Disorders Drug: AMARGOL® Phase 3

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  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Phase III - Efficacy Study of AMARGOL - Phytomedicine on Therapeutics
Study Start Date : December 2008
Actual Primary Completion Date : April 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Coal Tar
U.S. FDA Resources

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



Primary Outcome Measures :
  1. VAS - visual analogue scale [ Time Frame: 24h ]
    Single dose 40mL AMARGOL 20 minutes before Dinner - strong meal



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

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): NCT01485328


Locations
Brazil
Phytopharm Consulting
Porto Alegre, RS, Brazil, 90130-021
Sponsors and Collaborators
Laboratorio Saude Ltda.
Phytopharm Consulting Brazil
Investigators
Principal Investigator: Angelo G Chaves, Doctor

Responsible Party: Laboratorio Saude Ltda.
ClinicalTrials.gov Identifier: NCT01485328     History of Changes
Other Study ID Numbers: labsaude-001-ama
First Posted: December 5, 2011    Key Record Dates
Last Update Posted: December 6, 2011
Last Verified: December 2011

Keywords provided by Laboratorio Saude Ltda.:
Dyspepsia
Flatulence
Aerophagia
Constipation

Additional relevant MeSH terms:
Digestive System Diseases
Gastrointestinal Diseases
Coal Tar
Keratolytic Agents
Dermatologic Agents