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

Digestive System Disorders Clinical Trial

— AMARGOL  

Official title:

Phase III - Efficacy Study of AMARGOL - Phytomedicine on Therapeutics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01485328
• Other study ID #: labsaude-001-ama
• Status: Completed
• Phase: Phase 3
• First received: December 16, 2008
• Last updated: December 5, 2011
• Start date: December 2008
• Est. completion date: September 2009

Study information

• Verified date: December 2011
• Source: Laboratorio Saude Ltda.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Digestive System Diseases
• Digestive System Disorders
• Gastrointestinal Diseases

Intervention

Drug:
• AMARGOL®
per oral solution, 40 mL single dose

Locations

Country	Name	City	State
Brazil	Phytopharm Consulting	Porto Alegre	RS

Sponsors (2)

Lead Sponsor	Collaborator
Laboratorio Saude Ltda.	Phytopharm Consulting Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS - visual analogue scale	Single dose 40mL AMARGOL 20 minutes before Dinner - strong meal	24h	No