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

Primary Purpose

Digestive System Disorders

Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
AMARGOL®
Sponsored by
Laboratorio Saude Ltda.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Digestive System Disorders focused on measuring Dyspepsia, Flatulence, Aerophagia, Constipation

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts 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.

Sites / Locations

  • Phytopharm Consulting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

AMARGOL

Vehicle without active principles

Arm Description

per oral solution 40 mL single dose

per oral solution 40 mL single dose

Outcomes

Primary Outcome Measures

VAS - visual analogue scale
Single dose 40mL AMARGOL 20 minutes before Dinner - strong meal

Secondary Outcome Measures

Full Information

First Posted
December 16, 2008
Last Updated
December 5, 2011
Sponsor
Laboratorio Saude Ltda.
Collaborators
Phytopharm Consulting Brazil
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1. Study Identification

Unique Protocol Identification Number
NCT01485328
Brief Title
Protocol: Phytomedicine-AMARGOL®, Clinical Trial for Efficacy Proof on Therapeutics
Acronym
AMARGOL
Official Title
Phase III - Efficacy Study of AMARGOL - Phytomedicine on Therapeutics
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratorio Saude Ltda.
Collaborators
Phytopharm Consulting Brazil

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Digestive System Disorders
Keywords
Dyspepsia, Flatulence, Aerophagia, Constipation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AMARGOL
Arm Type
Active Comparator
Arm Description
per oral solution 40 mL single dose
Arm Title
Vehicle without active principles
Arm Type
Placebo Comparator
Arm Description
per oral solution 40 mL single dose
Intervention Type
Drug
Intervention Name(s)
AMARGOL®
Other Intervention Name(s)
AMARGOL, Phytomedicine, Herbal Extracts Mixture
Intervention Description
per oral solution, 40 mL single dose
Primary Outcome Measure Information:
Title
VAS - visual analogue scale
Description
Single dose 40mL AMARGOL 20 minutes before Dinner - strong meal
Time Frame
24h

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angelo G Chaves, Doctor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Phytopharm Consulting
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90130-021
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

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

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