Protocol: Phytomedicine-AMARGOL®, Clinical Trial for Effi... | NCT01485328

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

NCT01485328

Sponsor

Laboratorio Saude Ltda.

Status

Completed

Last Update Posted

Dec 6, 2011Estimated

Enrollment

60Actual

Phase

Phase 3

Conditions

Digestive System Disorders

Interventions

AMARGOL®

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2008

Primary Completion Date

Apr 2009Actual

Completion Date

Sep 2009Actual

First Submitted Date

Dec 16, 2008

First Submission Date that Met QC Criteria

Dec 2, 2011

First Posted Date

Dec 5, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 5, 2011

Last Update Posted Date

Dec 6, 2011Estimated

Name	Class
Phytopharm Consulting Brazil	NETWORK

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AMARGOL	Active Comparator	per oral solution 40 mL single dose	Drug: AMARGOL®
Vehicle without active principles	Placebo Comparator	per oral solution 40 mL single dose	Drug: AMARGOL®

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AMARGOL®	Drug	per oral solution, 40 mL single dose	AMARGOL Vehicle without active principles

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
VAS - visual analogue scale	Single dose 40mL AMARGOL 20 minutes before Dinner - strong meal	24h

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Angelo G Chaves, Doctor		Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Phytopharm Consulting		Porto Alegre	Rio Grande do Sul	90130-021	Brazil

Condition Browse Module

MeSH Terms

ID	Term
D004066	Digestive System Diseases
D004415	Dyspepsia
D005414	Flatulence
D000334	Aerophagy
D003248	Constipation

Ancestor Terms

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided