Saffron as Anti Inflammatory Agent In Patients With Inflammatory Bowel Disease

Status unconfirmed · Not applicable · Has a placebo group

Conditions studied: Ulcerative Colitis

In brief

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 investigators use saffron extract in patients with colitis for 8 weeks.

Key facts

Study ID

NCT04749576

Run by

Howard University

People needed

100

Starts

2020-12-15

Expected to finish

2023-12-10

Last updated by the study team

2021-02-11

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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).
• 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.

You may not qualify if…

• 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

Where it is running

• Howard University Hospital — Washington D.C., District of Columbia, United States (enrolling)

Full record on ClinicalTrials.gov

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