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 ]
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