Use of Maytenus Ilicifolia in the Treatment of Dyspepsia

This study has been terminated.

(Lack of adherence and huge loss of follow up.)

Sponsor:

Collaborator:

University of Sao Paulo

Information provided by (Responsible Party):

Fabio Carmona, University of Sao Paulo

ClinicalTrials.gov Identifier:

NCT01408849

First received: July 29, 2011

Last updated: July 25, 2016

Last verified: July 2016

History of Changes

Purpose

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).

Condition	Intervention	Phase
Dyspepsia	Drug: Maytenus ilicifolia leaves infusion Drug: Omeprazole	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Use of Maytenus Ilicifolia Mart. ex Reiss in the Treatment of Dyspepsia

Resource links provided by NLM:

MedlinePlus related topics: Indigestion

Drug Information available for: Omeprazole Omeprazole magnesium

U.S. FDA Resources

Further study details as provided by Casa Espirita Terra de Ismael:

Primary Outcome Measures:

SODA score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Sydney classification [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]


Enrollment:	4
Study Start Date:	February 2015
Study Completion Date:	January 2016
Primary Completion Date:	January 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Maytenus Tea of Martens ilicifolia leaves	Drug: Maytenus ilicifolia leaves infusion 2 g of powdered leaves in 150 mL of boiling water, 3 times a day, for 8 weeks
Active Comparator: Omeprazole Omeprazole as active comparator	Drug: Omeprazole Standard therapy

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01408849

Locations


Brazil
Hospital das Clinicas FMRP-USP
Ribeirao Preto, SP, Brazil, 14049-900

Sponsors and Collaborators

Casa Espirita Terra de Ismael

University of Sao Paulo

Investigators


Study Director:	Ana MS Pereira, PhD	University of Ribeirao Preto
Study Chair:	Jose S Santos, MD, PhD	HCFMRP-USP
Principal Investigator:	Fabio Carmona, MD, PhD	HCFMRP-USP
Principal Investigator:	Suzeidi B Castanheira, MD, PhD	HCFMRP-USP

More Information


Responsible Party:	Fabio Carmona, Assistant Professor, University of Sao Paulo
ClinicalTrials.gov Identifier:	NCT01408849 History of Changes
Other Study ID Numbers:	Maytenus2011
Study First Received:	July 29, 2011
Last Updated:	July 25, 2016
Health Authority:	Brazil: Conselho Nacional de Etica em Pesquisa (CONEP)

Keywords provided by Casa Espirita Terra de Ismael:


Endoscopy Herbal medicine Phytotherapy

Additional relevant MeSH terms:


Dyspepsia Signs and Symptoms, Digestive Signs and Symptoms Omeprazole Anti-Ulcer Agents	Gastrointestinal Agents Proton Pump Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 28, 2016

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