Use of Maytenus Ilicifolia in the Treatment of Dyspepsia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Casa Espirita Terra de Ismael.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
University of Sao Paulo
Information provided by:
Casa Espirita Terra de Ismael
ClinicalTrials.gov Identifier:
NCT01408849
First received: July 29, 2011
Last updated: August 2, 2011
Last verified: July 2011
  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
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
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 ]
    The SODA score will be assessed before treatment and after 8 weeks of treatment


Secondary Outcome Measures:
  • Sydney classification [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    The Sydney classification will be done before treatment and after 8 weeks of treatment


Estimated Enrollment: 20
Study Start Date: September 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Maytenus ilicifolia leaves infusion
    2 g of powdered leaves in 150 mL of boiling water, 3 times a day, for 8 weeks
  Eligibility

Ages Eligible for Study:   18 Years and older
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01408849

Contacts
Contact: Fabio Carmona, MD, PhD 5516-3602-2478 carmona@fmrp.usp.br
Contact: Suzeidi B Castanheira, MD, PhD 5516-3621-8708 suzirp@hotmail.com

Locations
Brazil
Hospital das Clinicas FMRP-USP Not yet recruiting
Ribeirao Preto, SP, Brazil, 14049-900
Contact: Suzeido B Castanheira, MD, PhD    5516-3621-8708    suzirp@hotmail.com   
Principal Investigator: Suzeidi B Castanheira, MD, PhD         
Sponsors and Collaborators
Casa Espirita Terra de Ismael
University of Sao Paulo
Investigators
Study Director: Ana MS Pereira, PhD UNAERP
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, HCFMRP-USP
ClinicalTrials.gov Identifier: NCT01408849     History of Changes
Other Study ID Numbers: Maytenus2011
Study First Received: July 29, 2011
Last Updated: August 2, 2011
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

ClinicalTrials.gov processed this record on April 14, 2014