drugset / Trial / NCT05117749

Saffron and Ulcerative Colitis

NCT05117749

Phase 2 Unknown 60 enrolled Shiraz University of Medical Sciences
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2023-05
Primary completion
2025-02
Completion
2025-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Saffron Traditional medicine (herbal / TCM) 50 mg
Subject Saffron Traditional medicine (herbal / TCM) 100 mg

Indications