Ulcerative colitis
Conditions
Interventions
Carminal Group (experimental): Carminal + Standard therapy. Carminal will be administered one vial (30 ml), oral solution, every 12 hours, administered with breakfast and lunch for 6 months
Placebo g
Sponsors
Catalysis Laboratories, SL
National Coordinating Center for Clinical Trials
Eligibility
Sex/Gender
All
Age
19 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients who meet the diagnostic criteria. 2. Patients aged = 19 years. 3. Patients who have signed the informed consent for the research.
Exclusion criteria
Exclusion criteria: 1. Patients with neuropsychiatric disorders that prevent the patient from expressing their willingness to participate in the study or hinder their evaluation. 2. Patients with hypersensitivity or a history of allergy to Carminal® or some of its components. 3. Patients with decompensated chronic diseases (diabetes mellitus, venous insufficiency, arterial hypertension, bronchial asthma, interstitial fibrosis, chronic renal failure, ischemic heart disease, symptomatic congestive heart failure, aortic stenosis, endocarditis, unstable angina pectoris, cardiac arrhythmia). 4. Patient who is participating in another clinical trial or receiving another investigational product at the time of selection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quality of life (IBDQ-32 Questionnaire. It has 32 items distributed in 4 dimensions: digestive symptoms (10 items), systemic symptoms (five items), emotional affectation (five items) and social (12 items). The responses to each item are expressed on a 7-point scale, where 7 corresponds to the best perception of health-related quality of life. A score is calculated for all items and a score for each dimension). Measurement time: At baseline and, a week after end of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Activity and Severity of Ulcerative Colitis 1. Symptoms (Frequency of stools (Formed stools, between 1 and 3 stools/day (unformed), between 4 and 6 stools/day, between 7 and 10 stools/day, more than 10 stools/day), Bleeding in stools (None, intermittent, frequent or continuous), Urgency to defecate: never, occasionally, frequently, continually)). Measurement time: At baseline, month 3 and one week after end of treatment 2. Laboratory parameters (Fecal Calprotectin (Negative, Positive), Hemoglobin (Normal, Dis, Transfusion requirements), Erythrocyte sedimentation rate (Normal, Elevated), Quantitative C-reactive protein (Normal, Elevated)). Measurement time: At baseline, month 3 and one week after end of treatment 3. Other laboratory parameters that measure inflammatory activity (Total leukocyte count (Normal, Elevated), Neutrophils (Normal, Elevated), Lymphocytes (Normal, Elevated), Platelets (Normal, Elevated), Albumin (Normal, Elevated)). Time measurement: At baseline, month 3 and one week after the end of treatment Clinical response 1. Clinical remission (Simple Colitis Activity Index, SCCAI. The category “Remission” is established when the total score is less than or equal to 2 points. The category “Active disease” is established when the total score is greater than 2 points). Measurement time: at baseline, month 3 and one week after the end of treatment 2. Clinical improvement (Simple Colitis Activity Index, SCCAI). The categories are established: Improvement when the final total score, with respect to the baseline value, decreases by 3 or more points, No improvement-Stable when the change in the score is not greater than 2 points with respect to the baseline value and No improvement-worse when the final total score increases by 3 points or more with respect to the baseline value score). Measurement time: at baseline, month 3 and one week after the end of treatment | — |
Countries
Cuba
Contacts
Public ContactAnaelys Maceo Sinabele
National Coordinating Center for Clinical Trials
Outcome results
None listed