Digestive System Disorders
Conditions
Keywords
Dyspepsia, Flatulence, Aerophagia, Constipation
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
Interventions
DRUGAMARGOL®
per oral solution, 40 mL single dose
Sponsors
Phytopharm Consulting Brazil
Laboratorio Saude Ltda.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VAS - visual analogue scale | 24h | Single dose 40mL AMARGOL 20 minutes before Dinner - strong meal |
Countries
Brazil
Outcome results
None listed