Use of Maytenus Ilicifolia in the Treatment of Dyspepsia

Casa Espirita Terra de Ismael

Status and phase: Terminated; Phase 2

Conditions: Dyspepsia

Treatments: Drug: Omeprazole; Drug: Maytenus ilicifolia leaves infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT01408849

Maytenus2011

Details and patient eligibility

About

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).

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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4 participants in 2 patient groups

Maytenus

Experimental group

Description:

Tea of Martens ilicifolia leaves

Treatment:

Drug: Maytenus ilicifolia leaves infusion

Omeprazole

Active Comparator group

Description:

Omeprazole as active comparator

Treatment:

Drug: Omeprazole