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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase III - Efficacy Study of AMARGOL - Phytomedicine on Therapeutics

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

Detailed Summary:

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


Sponsor: Laboratorio Saude Ltda.

Current Primary Outcome: VAS - visual analogue scale [ Time Frame: 24h ]

Single dose 40mL AMARGOL 20 minutes before Dinner - strong meal


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Laboratorio Saude Ltda.

Dates:
Date Received: December 16, 2008
Date Started: December 2008
Date Completion:
Last Updated: December 5, 2011
Last Verified: December 2011