Use of Maytenus Ilicifolia in the Treatment of Dyspepsia

This study has suspended participant recruitment.
(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: January 26, 2016
Last verified: January 2016
  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:


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: January 2016
Estimated 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: January 26, 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 July 24, 2016