Heartburn
Conditions
Interventions
Three groups will be considered, two experimental groups and a control group.
Experimental Group 1, 133 voluntary patients with dyspepsia symptoms should take capsules containing dry extract of Mayte
53262
Sponsors
Universidade Federal do Rio Grande do Sul
Universidade Federal do Rio Grande do Sul
Eligibility
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Voluntary patients, of both sexes, aged between 18 and 60 years who are looking for medical attention in Health Units and who, after medical evaluation, present symptoms of dyspepsia, at least two of these symptoms, regurgitation, taste of sour or bitter fluid in the mouth, and/or epigastric pain and/or burning pain (ascending or not) in the week before the consultation, of gastroesophageal reflux disease. Patients able to be treated without endoscopic investigation and without evidence of disease or use of medication that justifies the symptoms will be included.
Exclusion criteria
Exclusion criteria: Patients who are referred for an endoscopic examination and who are intolerant to the treatment compounds will be excluded from the medical evaluation. Pregnant women or women of reproductive age who do not use hormonal contraceptives will be excluded. Patients with a history of glaucoma, paralytic ileum, stenosis or mechanical obstruction of the gastrointestinal tract, megacolon, patients with acute-angle glaucoma, urinary retention or prostate hyperplasia will be excluded patients using any drugs with antiulcer or prokinetic properties in the week prior to recruitment that present structural changes related to reflux and dyspepsia, such as hiatus hernia and esophageal atresia, hepatopathies and patients using drugs that make pharmacological interaction with compounds of Maytenus ilicifolia dry extract.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcome 1: It is expected to find an improvement in dyspepsia symptoms verified by the method of application of the Gastroesophageal Reflux Symptoms questionnaire (“reflux symptoms” QS -GERD). The rate of satisfactory symptom relief in the plant group was estimated at an increase of 39%. Data collected at the beginning of the clinical trial and at the end. | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected outcome 2: It is expected to find an improvement in salivary pepsin and pH levels assessed in the saliva sample using specific commercial kits. Samples collected at the beginning of the clinical trial and at the end.;Expected outcome 1: It is expected to find an improvement in the quality of life affected by heartburn symptoms verified by the method of application of the Heartburn-Specific Quality of Life questionnaire (Heartburn Specific Quality of Life HBQOL). The rate of satisfactory symptom relief in the plant group was estimated at an increase of 39%. Data collected at the beginning of the clinical trial and at the end. | — |
Countries
Brazil
Contacts
Public ContactKatherine Solís-Cordero
Outcome results
None listed