Use of Maytenus Ilicifolia in the Treatment of Dyspepsia

NCT ID: NCT01408849

Last Updated: 2016-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2016-01-31

Brief Summary

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This study aims to evaluate the therapeutic effect of the infusion of Maytenus ilicifolia Mart. ex Reiss leaves, used for 8 weeks, on patients with dyspepsia. Primary endpoint is SODA score, secondary endpoint is endoscopic classification (Sydney).

Detailed Description

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Conditions

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Dyspepsia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Maytenus

Tea of Martens ilicifolia leaves

Group Type EXPERIMENTAL

Maytenus ilicifolia leaves infusion

Intervention Type DRUG

2 g of powdered leaves in 150 mL of boiling water, 3 times a day, for 8 weeks

Omeprazole

Omeprazole as active comparator

Group Type ACTIVE_COMPARATOR

Omeprazole

Intervention Type DRUG

Standard therapy

Interventions

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Maytenus ilicifolia leaves infusion

2 g of powdered leaves in 150 mL of boiling water, 3 times a day, for 8 weeks

Intervention Type DRUG

Omeprazole

Standard therapy

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* age \> 18 years
* being literate
* diagnosis of dyspepsia
* initial SODA score \> or = 25

Exclusion Criteria

* pregnancy
* lactation
* allergy to Maytenus species
* fail to use the drug for 3 uninterrupted weeks
* new onset serious adverse events, attributable to the drug
* patient's request
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role collaborator

Casa Espirita Terra de Ismael

OTHER

Sponsor Role lead

Responsible Party

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Fabio Carmona

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ana MS Pereira, PhD

Role: STUDY_DIRECTOR

University of Ribeirao Preto

Jose S Santos, MD, PhD

Role: STUDY_CHAIR

HCFMRP-USP

Fabio Carmona, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

HCFMRP-USP

Suzeidi B Castanheira, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

HCFMRP-USP

Locations

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Hospital das Clinicas FMRP-USP

Ribeirão Preto, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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Maytenus2011

Identifier Type: -

Identifier Source: org_study_id

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