Saffron and Ulcerative Colitis

NCT05117749 | Unknown Phase 2

• 1 other identifier: 24540
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Ulcerative Colitis

Keywords

saffron; Ulcerative Colitis; inflammatory bowel disease; randomized double-blind clinical trial

Outcome Measures

Primary Outcomes (4)

• Changes in clinical response

  Changes in clinical response will be assessed by "Simple Clinical Colitis Activity Index", which has a total score between 0 to 19. Higher scores are interpreted to higher disease activity (worse outcome).

  4 and 8 weeks

• Changes in the fecal calprotectin level

  4 and 8 weeks

• Changes in the serum levels of CRP

  4 and 8 weeks

• Changes in the serum levels of ESR

  4 and 8 weeks

Secondary Outcomes (6)

• Changes in the serum anti-inflammatory and pro-inflammatory markers

  8 week

• Changes in the Health-related quality of life (HRQoL )

  8, 24, and 48 weeks

• Changes in the stool microbiome and transcriptome

  8 week

• Safety assessment (Incidence of Treatment-Emergent Adverse Events)

  8 week

• Changes in the anxiety

  8, 24, and 48 weeks

Study Arms (6)

Mild UC-Saffron 100

EXPERIMENTAL

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

Drug: Saffron 100

Moderate UC-Saffron 100

EXPERIMENTAL

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

Drug: Saffron 100

Mild UC-Saffron 50

EXPERIMENTAL

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

Drug: Saffron 50

Moderate UC-Saffron 50

EXPERIMENTAL

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

Drug: Saffron 50

Mild UC-placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Moderate UC-placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Saffron 100 DRUG

to Mild and Moderate UC patients

Mild UC-Saffron 100; Moderate UC-Saffron 100

Saffron 50 DRUG

to Mild and Moderate UC patients

Mild UC-Saffron 50; Moderate UC-Saffron 50

Placebo DRUG

to Mild and Moderate UC patients

Mild UC-placebo; Moderate UC-placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients between 18-80 years' old
• 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.
• Patients with the ability to give written informed consent and to be compliant with the schedule of intervention and assessments
• Patients with mild (3-5) or moderate (6-11) UC, according to the Simple Clinical Colitis Activity Index

You may not qualify if:

• Pregnant patients or those planning pregnancy
• Patients receiving immunosuppressive agents for diseases other than UC
• Patients with confirmed cancer, dysplasia, autoimmune, and rheumatology diseases
• Patients who had surgery for UC treatment
• 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
• Patients who have any condition affecting oral drug absorption.
• Subjects with known active or untreated GI infections including C.diff, CMV, HSV, HIV
• 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

Sponsors & Collaborators

• Shiraz University of Medical Sciences: lead

MeSH Terms

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Central Study Contacts

Ali Reza Safarpour, MD., Ph.D.

CONTACT

+98-7136281442; safarpourar@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Both patients and investigators do not know whether the participant receiving a placebo or saffron.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Manager in chief of gastroenterohepatology research center, Assistant Professor

Model Details: Sixty eligible patients will be recruited and randomized into 6 groups to receive either saffron capsule or placebo.

Study Record Dates

• First Submitted: October 21, 2021
• First Posted: November 11, 2021
• Study Start: May 1, 2023
• Primary Completion: February 1, 2025
• Study Completion: August 1, 2025
• Last Updated: May 11, 2022

Record last verified: 2022-05