Status:
COMPLETED
Protocol: Phytomedicine-AMARGOL®, Clinical Trial for Efficacy Proof on Therapeutics
Lead Sponsor:
Laboratorio Saude Ltda.
Collaborating Sponsors:
Phytopharm Consulting Brazil
Conditions:
Digestive System Disorders
Eligibility:
MALE
18-45 years
Phase:
PHASE3
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 spe...
Eligibility Criteria
Inclusion
- 18-45 years old
- 65-85 Kg
- healthy volunteers
Exclusion
- chronic dyspeptics illness chronic congestive cardiac problems
- pulmonary problems
- diabetes, thyroid problems
- pregnancy
- bowel syndrome
- hemorrhoids
- colitis
- allergies for any formula components.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01485328
Start Date
December 1 2008
End Date
September 1 2009
Last Update
December 6 2011
Active Locations (1)
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1
Phytopharm Consulting
Porto Alegre, Rio Grande do Sul, Brazil, 90130-021