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Use of Maytenus Ilicifolia in the Treatment of Dyspepsia

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ClinicalTrials.gov Identifier: NCT01408849
Recruitment Status : Terminated (Lack of adherence and huge loss of follow up.)
First Posted : August 3, 2011
Last Update Posted : July 26, 2016
Sponsor:
Collaborator:
University of Sao Paulo
Information provided by (Responsible Party):
Fabio Carmona, University of Sao Paulo

Study Description
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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).

Condition or disease Intervention/treatment Phase
Dyspepsia Drug: Maytenus ilicifolia leaves infusion Drug: Omeprazole Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Use of Maytenus Ilicifolia Mart. ex Reiss in the Treatment of Dyspepsia
Study Start Date : February 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Indigestion
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. SODA score [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Sydney classification [ Time Frame: 8 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Fabio Carmona, Assistant Professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01408849     History of Changes
Other Study ID Numbers: Maytenus2011
First Posted: August 3, 2011    Key Record Dates
Last Update Posted: July 26, 2016
Last Verified: July 2016

Keywords provided by Fabio Carmona, University of Sao Paulo:
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