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CompletedNCT01485328AMARGOLUpdated Dec 6, 2011

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

A Phase 3 interventional study of AMARGOL® in Digestive System Disorders, sponsored by Laboratorio Saude Ltda.. Completed at 1 site in Brazil. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-12-06.

Sponsored by Laboratorio Saude Ltda. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Male
01

Study summary

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

Read the detailed 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

02

Conditions studied

  • Digestive System Disorders

Keywords

  • Dyspepsia
  • Flatulence
  • Aerophagia
  • Constipation
03

In context

Digestive System Diseases

615 studies on the registry are indexed under Digestive System Diseases; 114 are open to participants now.

This study's enrollment of 60 is below the median of 80 across 402 interventional studies indexed under Digestive System Diseases.

Browse Digestive System Diseases studies →

Lead sponsor

This is the only study on the registry with Laboratorio Saude Ltda. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 18-45 years old
  • 65-85 Kg
  • healthy volunteers

Exclusion criteria

Exclusion Criteria:

  • chronic dyspeptics illness chronic congestive cardiac problems
  • pulmonary problems
  • diabetes, thyroid problems
  • pregnancy
  • bowel syndrome
  • hemorrhoids
  • colitis
  • allergies for any formula components.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    AMARGOL

    per oral solution 40 mL single dose

    Drug: AMARGOL®

  • Placebo comparator
    Vehicle without active principles

    per oral solution 40 mL single dose

    Drug: AMARGOL®

Interventions

  • DrugAMARGOL®

    per oral solution, 40 mL single dose

    Also known as: AMARGOL, Phytomedicine, Herbal Extracts Mixture

06

What researchers measure

Primary outcomes

  1. VAS - visual analogue scale

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

    Time frame: 24h

07

Study locations

1 site
  • Phytopharm Consulting
    Porto Alegre, Rio Grande do Sul 90130-021, Brazil
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 6, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01485328
Lead sponsor
Laboratorio Saude Ltda.
Collaborators
Phytopharm Consulting Brazil
Responsible party
Sponsor
First posted
Dec 5, 2011
Start date
Dec 2008
Primary completion
Apr 2009
Completion
Sep 2009
Last update
Dec 6, 2011

Study contacts

Angelo G Chaves, Doctor
principal investigator

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2011. You cannot join it, but the record below documents what was studied.

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