Efficacy of Nutritional Saffron Supplement as an Anti-inflammatory Agent in Egyptian Patients With Inflammatory Bowel Disease

SaffronIBD

Nutritional Saffron supplement has been widely used as food supplement and has known anti-depressant and anti-inflammatory activities. The investigators use saffron extract in Egyptian patients with ulcerative colitis for 8 weeks.

2023-03-30

2023-05-30

2023-07-30

Not yet recruiting

Early phase I

90

Inclusion Criteria: 1. Male or female patients aged \>18 years 2. Have UC diagnosed at least 3 months prior to screening? The diagnosis of UC must be confirmed by endoscopic and histologic evidence. 3. Men and women of childbearing potential must agree to use adequate birth control measures during the study. 4. Ability to provide written informed consent and to be compliant with the schedule of protocol assessments, treatment plan, laboratory tests, and other study procedures. 5. UC patients with mild, mod, severity as assess by the 4 scale assessment (Normal, mild, mod, severe). 6. Treatment naïve subjects diagnosed with ulcerative colitis (without previous exposure to treatment). 7. UC patients already on a treatment might be considered, with saffron as an add-on 8. UC patients who displayed no improvement with any available treatment might be considered for saffron as an alternative treatment in this option. Exclusion Criteria: * 1 Patients taking immunosuppressive medicine for a disease other than UC 2 Rheumatologic disease and other underlying diseases that can interfere with the study process. 3 Pregnancy 4 If the UC has been present for \> 10 years, a colonoscopy with biopsy has to be performed to rule-out dysplasia. 5 A subject who had surgery as a treatment for ulcerative colitis or likely to require surgery during the study period. 6 Subjects with evidence of liver disease or abnormal liver enzymes and function tests (e.g. total bilirubin, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) higher than the upper limit of normal) at the screening visit. 7 Subjects who have any condition possibly affecting oral nutritional supplement absorption. 8 Any other condition which in the opinion of the investigators would make the subject unsuitable for inclusion in the study. 9 Patients with known active or untreated GI infections including C. difficile, CMV, HSV, HIV

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 90, 'type': 'ESTIMATED'}}

2023-03-17