NCT01408849

Brief Summary

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 3, 2011

Completed
3.5 years until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

July 26, 2016

Status Verified

July 1, 2016

Enrollment Period

11 months

First QC Date

July 29, 2011

Last Update Submit

July 25, 2016

Conditions

Dyspepsia

Keywords

EndoscopyHerbal medicinePhytotherapy

Outcome Measures

Primary Outcomes (1)

  • SODA score

    8 weeks

Secondary Outcomes (1)

  • Sydney classification

    8 weeks

Study Arms (2)

Maytenus

EXPERIMENTAL

Tea of Martens ilicifolia leaves

Drug: Maytenus ilicifolia leaves infusion

Omeprazole

ACTIVE COMPARATOR

Omeprazole as active comparator

Drug: Omeprazole

Interventions

Maytenus ilicifolia leaves infusionDRUG

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

Maytenus
OmeprazoleDRUG

Standard therapy

Omeprazole

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital das Clinicas FMRP-USP

Ribeirão Preto, São Paulo, 14049-900, Brazil

Location

MeSH Terms

Conditions

Dyspepsia

Interventions

Omeprazole

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Ana MS Pereira, PhD

    University of Ribeirao Preto

    STUDY DIRECTOR

  • Jose S Santos, MD, PhD

    HCFMRP-USP

    STUDY CHAIR

  • Fabio Carmona, MD, PhD

    HCFMRP-USP

    PRINCIPAL INVESTIGATOR

  • Suzeidi B Castanheira, MD, PhD

    HCFMRP-USP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 29, 2011

First Posted

August 3, 2011

Study Start

February 1, 2015

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

July 26, 2016

Record last verified: 2016-07

Locations

BR(1)