NCT05117749

Saffron and Ulcerative Colitis

The Effect of Saffron in Patients With Ulcerative Colitis: A Randomized Double-blind Clinical Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Shiraz University of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study will be a parallel, randomized, double-blinded clinical trial assessing the efficacy of the saffron extract compared to placebo in patients with mild and moderate UC. Sixty eligible patients will be recruited and randomized into 6 groups to receive either saffron capsule or placebo. Randomization will be performed by an independent researcher (AAK) who is not directly involved in the trial and using software-generated random permuted blocks. Allocation concealment will be also conducted using sealed, opaque envelopes with consecutive numbering. The saffron and placebo will be provided free of charge by Sina Pajoohan Salamat co, Mashhad, Iran. The standard treatment will be administered to all patients as recommendations of the physicians. Intervention The intervention groups of study will be included: 1. Mild UC patients, receiving100 milligram (mg)/day saffron for 8 weeks (50 mg two times (BID)), n=10 2. Moderate UC patients, receiving100 mg/day saffron for 8 weeks (50 mg BID), n=10 3. Mild UC patients, receiving 50 mg/day saffron for 8 weeks (25 mg BID), n=10 4. Moderate UC patients, receiving 50 mg/day saffron for 8 weeks (25 mg BID), n=10 5. Mild UC patients, receiving 2 tablets of placebo for 8 weeks, n=10 6. Moderate UC patients, receiving 2 tablets of placebo for 8 weeks, n=10 Demographic and baseline characteristics will be recorded, and assessment of anthropometric and biochemical parameters, fecal calprotectin, inflammatory cytokines, stool microbiome, and its transcriptomic, and metabolomic, urine and saliva metabolomics, health-related quality of life (HRQoL), anxiety, and disease severity will be done at baseline and after 8 weeks. Fecal calprotectin, C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), and disease severity will also be evaluated at 4th week. Moreover, HRQoL and anxiety will also be examined after 6 and 12 months.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	Saffron 100	to Mild and Moderate UC patients
DRUG	Saffron 50	to Mild and Moderate UC patients
DRUG	Placebo	to Mild and Moderate UC patients

Timeline

• Start date: 2023-05-01
• Primary completion: 2025-02-01
• Completion: 2025-08-01
• First posted: 2021-11-11
• Last updated: 2022-05-11