Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Use of Maytenus Ilicifolia in the Treatment of Dyspepsia

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2015 by Casa Espirita Terra de Ismael
University of Sao Paulo
Information provided by (Responsible Party):
Fabio Carmona, University of Sao Paulo Identifier:
First received: July 29, 2011
Last updated: February 2, 2015
Last verified: February 2015

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
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:

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 ]

Estimated Enrollment: 140
Study Start Date: February 2015
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: February 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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 identifier: NCT01408849

Contact: Fabio Carmona, MD, PhD 5516-3602-2478
Contact: Suzeidi B Castanheira, MD, PhD 5516-3621-8708

Hospital das Clinicas FMRP-USP Recruiting
Ribeirao Preto, SP, Brazil, 14049-900
Contact: Jowanka Amorim, RD    +5516982016664   
Principal Investigator: Fabio Carmona, MD, PhD         
Sponsors and Collaborators
Casa Espirita Terra de Ismael
University of Sao Paulo
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

No publications provided

Responsible Party: Fabio Carmona, Assistant Professor, University of Sao Paulo Identifier: NCT01408849     History of Changes
Other Study ID Numbers: Maytenus2011
Study First Received: July 29, 2011
Last Updated: February 2, 2015
Health Authority: Brazil: Conselho Nacional de Etica em Pesquisa (CONEP)

Keywords provided by Casa Espirita Terra de Ismael:
Herbal medicine

Additional relevant MeSH terms:
Signs and Symptoms
Signs and Symptoms, Digestive
Anti-Ulcer Agents
Enzyme Inhibitors
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Proton Pump Inhibitors
Therapeutic Uses processed this record on February 26, 2015