Status:
UNKNOWN
Saffron as Anti Inflammatory Agent In Patients With Inflammatory Bowel Disease
Lead Sponsor:
Howard University
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Nutritional Saffron supplement has been widely used as food supplement and has known anti-depressant and anti-inflammatory activities. It is generally consumed as stigmas in drinks or dishes. The inve...
Detailed Description
The patients invited to participate in a research study on Inflammatory Bowel Diseases (IBD) and saffron as a nutritional anti-inflammatory supplement. Inflammatory Bowel Disease (IBD) is composed of...
Eligibility Criteria
Inclusion
- Male or female patients aged \>18 years
- Have UC diagnosed at least 3 months prior to screening? The diagnosis of UC must be confirmed by endoscopic and histologic evidence.
- Men and women of childbearing potential must agree to use adequate birth control measures during the study.
- Ability to provide written informed consent and to be compliant with the schedule of protocol assessments, treatment plan, laboratory tests, and other study procedures.
- UC patients with mild, mod, severity as assess by the 4 scale assessment (Normal, mild, mod, severe).
- 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
- Patients taking immunosuppressive medicine for a disease other than UC
- Rheumatologic disease and other underlying diseases that can interfere with the study process.
- Pregnancy
- If the UC has been present for \> 10 years, a colonoscopy with biopsy has to be performed to rule-out dysplasia.
- A subject who had surgery as a treatment for ulcerative colitis or likely to require surgery during the study period.
- 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.
- Subjects who have any condition possibly affecting oral nutritional supplement absorption.
- Any other condition which in the opinion of the investigators would make the subject unsuitable for inclusion in the study.
- Patients with known active or untreated GI infections including C. difficile, CMV, HSV, HIV
Key Trial Info
Start Date :
December 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 10 2023
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04749576
Start Date
December 15 2020
End Date
December 10 2023
Last Update
February 11 2021
Active Locations (1)
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1
Howard University Hospital
Washington D.C., District of Columbia, United States, 20059