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Use of Maytenus Ilicifolia in the Treatment of Dyspepsia

This study has been terminated.
(Lack of adherence and huge loss of follow up.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01408849
First Posted: August 3, 2011
Last Update Posted: July 26, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Sao Paulo
Information provided by (Responsible Party):
Fabio Carmona, University of Sao Paulo
  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
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

Resource links provided by NLM:


Further study details as provided by Fabio Carmona, University of Sao Paulo:

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

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

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

Information from the National Library of Medicine

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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
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

Responsible Party: Fabio Carmona, Assistant Professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01408849     History of Changes
Other Study ID Numbers: Maytenus2011
First Submitted: July 29, 2011
First Posted: August 3, 2011
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