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

Laboratorio Saude Ltda.

Status and phase: Completed; Phase 3

Conditions: Digestive System Disorders

Treatments: Drug: AMARGOL®

Study type: Interventional

Funder types: NETWORK; Industry

Identifiers

NCT01485328

labsaude-001-ama

Details and patient eligibility

About

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

Full description

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

Enrollment: 60 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups, including a placebo group

AMARGOL

Active Comparator group

Description:

per oral solution 40 mL single dose

Treatment:

Drug: AMARGOL®

Vehicle without active principles

Placebo Comparator group

Description:

per oral solution 40 mL single dose

Treatment:

Drug: AMARGOL®