Category
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Primary study
Registry of Trials»Registro Público Cubano de Ensayos Clínicos
Year
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2021
INTERVENTION: Abexol Administration, Oral 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 tablespoon (˜5 mL) by oral route, three times a day, 30 minutes before breakfast, lunch and dinner for 8 weeks. Dietary Supplements Suspensions Tablets CONDITION: Digestive System Diseases Gastrointestinal symptoms Signs and Symptoms, Digestive PRIMARY OUTCOME: 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 OUTCOME: 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 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.
Epistemonikos ID: 78dcdd9876756350812759b9db59a737b5a3b4a0
First added on: Aug 25, 2024