Saffron and Ulcerative Colitis

Shiraz University of Medical Sciences

Status and phase: Not yet enrolling; Phase 2

Conditions: Ulcerative Colitis

Treatments: Drug: Saffron 50; Drug: Placebo; Drug: Saffron 100

Study type: Interventional

Funder types: Other

Identifiers

NCT05117749

24540

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

60 participants in 6 patient groups, including a placebo group

Mild UC-Saffron 100

Experimental group

Description:

Mild UC patients, receiving 100 milligram (mg)/day saffron for 8 weeks (50 mg two times (BID)), n=10

Treatment:

Drug: Saffron 100

Moderate UC-Saffron 100

Experimental group

Description:

Moderate UC patients, receiving100 mg/day saffron for 8 weeks (50 mg BID), n=10

Treatment:

Drug: Saffron 100

Mild UC-Saffron 50

Experimental group

Description:

Mild UC patients, receiving 50 mg/day saffron for 8 weeks (25 mg BID), n=10

Treatment:

Drug: Saffron 50

Moderate UC-Saffron 50

Experimental group

Description:

Moderate UC patients, receiving 50 mg/day saffron for 8 weeks (25 mg BID), n=10

Treatment:

Drug: Saffron 50

Mild UC-placebo

Placebo Comparator group

Description:

Mild UC patients, receiving 2 tablets of placebo for 8 weeks, n=10

Treatment:

Drug: Placebo

Moderate UC-placebo

Placebo Comparator group

Description:

Moderate UC patients, receiving 2 tablets of placebo for 8 weeks, n=10

Treatment:

Drug: Placebo