Overview

Saffron and Ulcerative Colitis

Status:
Not yet recruiting

Trial end date:
2024-08-01

Target enrollment:
0

Participant gender:
All

Summary

IBD is a chronic disease with two major types of Crohn's Disease (CD) and Ulcerative Colitis (UC). Nowadays, synthetic drugs and monoclonal antibodies are the most common types of drugs used for IBD management. However, due to their side effects and the high relapse rate, many researchers are looking for plant-derived products to manage the disease. Saffron, Crocus sativus L., is widely used as spice and medicine with anti-obesity, anticonvulsant, anti-hyperlipidemic, anti-tumor, antioxidant, and anti-inflammatory properties. Besides, there is evidence of the favorable effects of saffron on the gut microbiome. The main aim of this proposal is to evaluate the effect of saffron as a complementary supplement or add-on therapy in combination with current therapeutic agents in patients with mild and moderate UC.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Shiraz University of Medical Sciences

Criteria

Inclusion Criteria:

1. Male or female patients between 18-80 years' old

2. Patients who have received a diagnosis of UC at least 3 months prior to screening. The
diagnosis of UC must be confirmed by endoscopic and histologic evidence.

3. Patients with the ability to give written informed consent and to be compliant with
the schedule of intervention and assessments

4. Patients with mild (3-5) or moderate (6-11) UC, according to the Simple Clinical
Colitis Activity Index

Exclusion Criteria:

1. Pregnant patients or those planning pregnancy

2. Patients receiving immunosuppressive agents for diseases other than UC

3. Patients with confirmed cancer, dysplasia, autoimmune, and rheumatology diseases

4. Patients who had surgery for UC treatment

5. Individuals with liver disease or abnormal liver enzymes and function tests (e.g.
total bilirubin, aspartate aminotransferase (AST) or alanine aminotransferase (ALT))
at the screening visit

6. Patients who have any condition affecting oral drug absorption.

7. Subjects with known active or untreated GI infections including C.diff, CMV, HSV, HIV

8. Subjects with clinical features of CD; history of CD (Crohns colitis, or
Ileo-colitis), clinical signs of fulminant colitis, toxic megacolon, or Microscopic
Colitis, indeterminate Colitis, infectious Colitis, or ischemic colitis