Gastrointestinal symptoms
Conditions
Interventions
Control Group: Abexol (tablets) (50 mg): 1 tablet by oral route, three times a day, 30 minutes before breakfast, lunch and dinner for 8 weeks.
Experimental Group: Abexol (suspension) (50 mg): 1 tables
Dietary Supplements
Tablets
Administration, Oral
Sponsors
National Centre for Scientific Research
OSDE BioCubaFarma
Eligibility
Sex/Gender
All
Age
19 Years to 70 Years
Inclusion criteria
Inclusion criteria: Patients with non-erosive erythomatous gastritis, both sexes, aged between 19 and 70 years, with gastrointestinal symptoms such as: epigastralgia (abdominal pain localized in the epigastric region), heartburn, nausea, heartburn, flatulence, regurgitation, belching, abdominal distension, feeling of rapid satiety, vomiting, anorexia incomplete, emptying sensation, attend an outpatient consultation at the Institute of Gastroenterology and agree to participate in the study by signing the informed consent.
Exclusion criteria
Exclusion criteria: Patients with Confirmatory endoscopy of gastric, duodenal or esophageal ulcer. Organic lesions of the upper digestive tract that require specific treatment. Benign and malignant digestive neoplasms. Alarm symptoms (digestive bleeding, anemia, significant loss of body weight, progressive dysphagia, odynophagia, persistent vomiting, lymphadenopathy, palpation of abdominal mass). Active liver or kidney diseases. Other non-digestive neoplasms. Thyroid gland disorders. Irritable bowel syndrome. Pancreatic conditions (acute or acute chronic pancreatitis). Intra and extrahepatic bile duct disorders. Izchemic alterations. Glucose > 7 mmol / L, and ALT> 55 IU, and / or creatinine> 130 umol / L. Diastolic blood > 105 mm Hg. Patients with any other special condition that at the discretion of the doctor puts their health and life at risk during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| GSRS (Significant improvement in the GSRS survey score). The treatments will be considered effective if the improvement obtained at the end of the study is significantly different from the baseline level. The validated questionnaire called Gastrointestinal Symptom Rating Scale (GSRS) will be used, to discriminate digestive symptoms, which consists of 15 questions that are answered using a scale that ranges from 0-3 points: from not presenting symptoms (0) to suffering them in the most severe way. frequent and intense (3). The global score ranges from 0-45 points, the lower the better the patient's condition in terms of gastrointestinal symptoms). Measurement time: At baseline and 8 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Symptoms of GSRS scale (Significant reduction in the intensity of symptoms) Measurement time: at baseline and the end of the 8 weeks of treatment. 2. Consumption of antacids (Yes, No. Significant reduction in the consumption of antacids). Measurement time: at the end of the 8 weeks of treatment. 3. Quality of life questionaire SF-36 (Improvement in the score. The SF-36 Questionnaire is made up of 36 questions (items) that assess both positive and negative health states. The questionnaire covers 8 scales, which represent the health concepts used most frequently in the main health questionnaires, as well as the aspects most related to the disease and its treatment. The 36 items of the instrument cover the following scales: Physical function, Physical role, Body pain, General health, Vitality, Social function, Emotional role and Mental health). Measurement time: at baseline and the end of the 8 weeks of treatment | — |
Countries
Cuba
Contacts
Public ContactJulio Fernandez Travieso
Clinical Trials Unit, National Centre for Scientific Research
Outcome results
None listed