Trial | NCT01485328  Report issue

Title

Protocol: Phytomedicine-AMARGOL®, Clinical Trial for Efficacy Proof on Therapeutics
Phase III - Efficacy Study of AMARGOL - Phytomedicine on Therapeutics

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    amargol ...

  • Study Participants

    60
This is a Phase 3: Efficacy Study for AMARGOL® a phytomedicine used for asymptomatic digestive complaints.
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 Started
Dec 31
2008
Primary Completion
Apr 30
2009
Study Completion
Sep 30
2009
Last Update
Dec 06
2011
Estimate

Drug AMARGOL®

per oral solution, 40 mL single dose

  • Other names: AMARGOL, Phytomedicine, Herbal Extracts Mixture

AMARGOL Active Comparator

per oral solution 40 mL single dose

Vehicle without active principles Placebo Comparator

per oral solution 40 mL single dose

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.
No Results Posted