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Use of Maytenus Ilicifolia in the Treatment of Dyspepsia

Primary Purpose

Dyspepsia

Status

Terminated

Phase

Phase 2

Locations

Brazil

Study Type

Interventional

Intervention

Maytenus ilicifolia leaves infusion

Omeprazole

About this trial

This is an interventional treatment trial for Dyspepsia focused on measuring Endoscopy, Herbal medicine, Phytotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hospital das Clinicas FMRP-USP

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Maytenus

Omeprazole

Arm Description

Tea of Martens ilicifolia leaves

Omeprazole as active comparator

Outcomes

Primary Outcome Measures

SODA score

Secondary Outcome Measures

Sydney classification

Full Information

NCT ID

NCT01408849

First Posted

July 29, 2011

Last Updated

July 25, 2016

Sponsor

Casa Espirita Terra de Ismael

Collaborators

University of Sao Paulo

1. Study Identification

Unique Protocol Identification Number

NCT01408849

Brief Title

Use of Maytenus Ilicifolia in the Treatment of Dyspepsia

Official Title

Use of Maytenus Ilicifolia Mart. ex Reiss in the Treatment of Dyspepsia

Study Type

Interventional

2. Study Status

Record Verification Date

July 2016

Overall Recruitment Status

Terminated

Why Stopped

Lack of adherence and huge loss of follow up.

Study Start Date

February 2015 (undefined)

Primary Completion Date

January 2016 (Actual)

Study Completion Date

January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Casa Espirita Terra de Ismael

Collaborators

University of Sao Paulo

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dyspepsia

Keywords

Endoscopy, Herbal medicine, Phytotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Maytenus

Arm Type

Experimental

Arm Description

Tea of Martens ilicifolia leaves

Arm Title

Omeprazole

Arm Type

Active Comparator

Arm Description

Omeprazole as active comparator

Intervention Type

Drug

Intervention Name(s)

Maytenus ilicifolia leaves infusion

Intervention Description

2 g of powdered leaves in 150 mL of boiling water, 3 times a day, for 8 weeks

Intervention Type

Drug

Intervention Name(s)

Omeprazole

Intervention Description

Standard therapy

Primary Outcome Measure Information:

Title

SODA score

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

Sydney classification

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ana MS Pereira, PhD

Organizational Affiliation

University of Ribeirao Preto

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Jose S Santos, MD, PhD

Organizational Affiliation

HCFMRP-USP

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Fabio Carmona, MD, PhD

Organizational Affiliation

HCFMRP-USP

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Suzeidi B Castanheira, MD, PhD

Organizational Affiliation

HCFMRP-USP

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital das Clinicas FMRP-USP

City

Ribeirao Preto

State/Province

ZIP/Postal Code

14049-900

Country

Brazil

12. IPD Sharing Statement

Learn more about this trial

Use of Maytenus Ilicifolia in the Treatment of Dyspepsia

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