DyspepsiaPhase 2NCT01408849
Use of Maytenus Ilicifolia in the Treatment of Dyspepsia
A Phase 2 study testing Maytenus ilicifolia leaves infusion and Omeprazole in people with Dyspepsia, run by Casa Espirita Terra de Ismael at 1 site in Brazil.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyspepsia
- What is being tested?
- Maytenus ilicifolia leaves infusion and Omeprazole
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2015to Jan 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age > 18 years
- being literate
- diagnosis of dyspepsia
- initial SODA score > or = 25
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital das Clinicas FMRP-USP
Ribeirão Preto, São Paulo, 14049-900
About this study
Official title: Use of Maytenus Ilicifolia Mart. ex Reiss in the Treatment of Dyspepsia
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).
- Conditions
- Dyspepsia
- Being tested
- Maytenus ilicifolia leaves infusion, Omeprazole
- Keywords
- Endoscopy, Herbal medicine, Phytotherapy
- Medical subject headings
- Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maytenus ilicifolia leaves infusionDrug
2 g of powdered leaves in 150 mL of boiling water, 3 times a day, for 8 weeks
OmeprazoleDrug
Standard therapy
| Study group | Role | What they receive |
|---|---|---|
| Maytenus | Experimental | Tea of Martens ilicifolia leaves Receives: Drug: Maytenus ilicifolia leaves infusion |
| Omeprazole | Active comparator | Omeprazole as active comparator Receives: Drug: Omeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
SODA score
Measured: 8 weeks
Secondary outcomes (1)
Sydney classification
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2011 (estimated)
- Study startFeb 2015
- Primary completionJan 2016
- Study completionJan 2016
Why it stopped: Lack of adherence and huge loss of follow up.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspepsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Casa Espirita Terra de Ismael
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sao Paulo
- Responsible party
- Principal investigator, Fabio Carmona, University of Sao Paulo
- Investigators
- Ana MS Pereira, PhD, Study director, University of Ribeirao PretoJose S Santos, MD, PhD, Study chair, HCFMRP-USPFabio Carmona, MD, PhD, Principal investigator, HCFMRP-USPSuzeidi B Castanheira, MD, PhD, Principal investigator, HCFMRP-USP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01408849
- Sponsor's protocol ID
- Maytenus2011
- Status last verified
- Jul 2016
- First submitted
- 29 Jul 2011
- Last updated
- 26 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Maytenus Ilicifolia Mart. ex Reiss in the Treatment of Dyspepsia
- ClinicalTrials.gov ID
- NCT01408849
- Acronym / sponsor ID
- Maytenus2011
- Conditions
- Dyspepsia
- Keywords
- Endoscopy, Herbal medicine, Phytotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of adherence and huge loss of follow up.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Casa Espirita Terra de IsmaelUniversity, hospital or other
- Collaborators
- University of Sao Paulo
- Study start
- Feb 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 3 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maytenus | Experimental | Drug: Maytenus ilicifolia leaves infusionTea of Martens ilicifolia leaves |
| Omeprazole | Active comparator | Drug: OmeprazoleOmeprazole as active comparator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age > 18 years
- being literate
- diagnosis of dyspepsia
- initial SODA score > or = 25
Key exclusion criteria (6 listed)
- pregnancy
- lactation
- allergy to Maytenus species
- fail to use the drug for 3 uninterrupted weeks
- new onset serious adverse events, attributable to the drug
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maytenus ilicifolia leaves infusion2 g of powdered leaves in 150 mL of boiling water, 3 times a day, for 8 weeks | Drug | Maytenus |
| OmeprazoleStandard therapy | Drug | Omeprazole |
Primary outcome
SODA score
Time frame: 8 weeks
1 secondary outcome
Sydney classification
Time frame: 8 weeks
Results and safety
The study was stopped early (reason given: Lack of adherence and huge loss of follow up.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana MS Pereira, PhD study director
University of Ribeirao Preto
Jose S Santos, MD, PhD study chair
HCFMRP-USP
Fabio Carmona, MD, PhD principal investigator
HCFMRP-USP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Maytenus ilicifolia leaves infusion and Omeprazole in people with Dyspepsia, run by Casa Espirita Terra de Ismael at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of adherence and huge loss of follow up.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SODA score (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2016.