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

Laboratorio Saude Ltda.60 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Digestive System Disorders

Interventions

AMARGOL®DRUG

per oral solution, 40 mL single dose

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Phytopharm Consulting

Porto Alegre, Rio Grande do Sul, Brazil

Outcomes

Primary Outcomes

VAS - visual analogue scale

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

Time frame: 24h

Data from ClinicalTrials.gov

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