Use of Maytenus Ilicifolia in the Treatment of Dyspepsia

Phase 2TerminatedNCT01408849

Casa Espirita Terra de Ismael4 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Dyspepsia

Interventions

Maytenus ilicifolia leaves infusionDRUG

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

OmeprazoleDRUG

Standard therapy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hospital das Clinicas FMRP-USP

Ribeirão Preto, São Paulo, Brazil

Outcomes

Primary Outcomes

SODA score

Time frame: 8 weeks

Secondary Outcomes

Sydney classification

Time frame: 8 weeks

Data from ClinicalTrials.gov

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