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Completed

NCT Number: NCT01485328

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

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

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Key information

Conditions

Digestive System Disorders Aerophagy Constipation Digestive System Diseases Dyspepsia Flatulence Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Phytopharm Consulting

Porto Alegre, Rio Grande do Sul, 90130-021, Brazil

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AMARGOL®

Drug

per oral solution, 40 mL single dose

Other names: AMARGOL, Phytomedicine, Herbal Extracts Mixture

Primary outcomes

  1. VAS - visual analogue scale

    Time frame: 24h

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

Sponsors and collaborators

Lead sponsor

Laboratorio Saude Ltda.

Industry

Collaborators

  • Phytopharm Consulting Brazil

Registry information

Official study title

Phase III - Efficacy Study of AMARGOL - Phytomedicine on Therapeutics

Acronym: AMARGOL

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Dec 5, 2011
Registry last updated
Dec 6, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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