Quality of life and safety of CARMINAL® nutritional supplement in patients with mild or moderate ulcerative colitis
- Conditions
- lcerative colitis
- Registration Number
- RPCEC00000434
- Lead Sponsor
- Catalysis Laboratories, S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 60
1. Patients who meet the diagnostic criteria.
2. Patients aged = 19 years.
3. Patients who have signed the informed consent for the research.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method