Use of Maytenus Ilicifolia in the Treatment of Dyspepsia
This study is not yet open for participant recruitment.
Verified July 2011 by Casa Espirita Terra de Ismael
Sponsor:
Casa Espirita Terra de Ismael
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
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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 June 17, 2013