Use of Maytenus Ilicifolia in the Treatment of Dyspepsia
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ClinicalTrials.gov Identifier: NCT01408849 |
Recruitment Status
:
Terminated
(Lack of adherence and huge loss of follow up.)
First Posted
: August 3, 2011
Last Update Posted
: July 26, 2016
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Dyspepsia | Drug: Maytenus ilicifolia leaves infusion Drug: Omeprazole | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 4 participants |
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 |
Study Start Date : | February 2015 |
Actual Primary Completion Date : | January 2016 |
Actual Study Completion Date : | January 2016 |

Arm | Intervention/treatment |
---|---|
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
|
- SODA score [ Time Frame: 8 weeks ]
- Sydney classification [ Time Frame: 8 weeks ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
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

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
Brazil | |
Hospital das Clinicas FMRP-USP | |
Ribeirao Preto, SP, Brazil, 14049-900 |
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 |
Responsible Party: | Fabio Carmona, Assistant Professor, University of Sao Paulo |
ClinicalTrials.gov Identifier: | NCT01408849 History of Changes |
Other Study ID Numbers: |
Maytenus2011 |
First Posted: | August 3, 2011 Key Record Dates |
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 |