Saffron as Anti Inflammatory In Patients With Inflammatory Bowel Disease

NCT05715099 | Unknown Phase 4

• 1 other identifier: SaffronIBD
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Nutritional Saffron supplement has been widely used as food supplement and has known anti-depressant and anti-inflammatory activities. The investigators use saffron extract in Egyptian patients with ulcerative colitis for 8 weeks.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (4)

• fecal calprotectin assessment

  Decrease in calprotectin levels. Fecal calprotectin normal range to be 10 to 60 μg/mg

  8 weeks

• C reactive protein assessment

  change on C reactive protein level reading is less than 10 milligram per liter

  8 weeks

• erythrocyte sedimentation rate assessment

  maintaining erythrocyte sedimentation rate with the normal range of 0 to 22 mm/hr for men and 0 to 29 mm/hr for women

  8 weeks

• The Ulcerative Colitis Colonoscopic Index of Severity scores

  Decrease of 2 or more unit in the Ulcerative Colitis Colonoscopic Index of Severity score. The Ulcerative Colitis Colonoscopic Index of Severity scores for mild colitis is 3-5, and for moderate is 5-9

  8 weeks

Secondary Outcomes (1)

• endoscopy colitis assessment

  8-12 weeks

Study Arms (6)

mild-moderate ulcerative colitis for low dose

ACTIVE COMPARATOR

2 low dose (25 mg \\dose) per day N= 20

Drug: Saffron

mild-moderate ulcerative colitis for high dose

ACTIVE COMPARATOR

2 high dose (50 mg \\dose) per day N=20

Drug: Saffron

healthy subjects for low dose

ACTIVE COMPARATOR

2 low dose (25 mg \\dose) per day N= 10

Drug: Saffron

healthy subjects for high dose

ACTIVE COMPARATOR

2 high dose (50 mg \\dose) per day N=10

Drug: Saffron

mild-moderate ulcerative colitis for placebo

PLACEBO COMPARATOR

2 dose placebo per day N=20

Drug: Placebo

healthy subjects for placebo

PLACEBO COMPARATOR

2 dose placebo per day N=10

Drug: Placebo

Interventions

Saffron DRUG

Dietary Supplement: saffron supplement for IBD

Also known as: safranal

healthy subjects for high dose; healthy subjects for low dose; mild-moderate ulcerative colitis for high dose; mild-moderate ulcerative colitis for low dose

Placebo DRUG

Dietary Supplement: placebo for IBD

healthy subjects for placebo; mild-moderate ulcerative colitis for placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female patients aged \>18 years
• Have UC diagnosed at least 3 months prior to screening? The diagnosis of UC must be confirmed by endoscopic and histologic evidence.
• Men and women of childbearing potential must agree to use adequate birth control measures during the study.
• Ability to provide written informed consent and to be compliant with the schedule of protocol assessments, treatment plan, laboratory tests, and other study procedures.
• UC patients with mild, mod, severity as assess by the 4 scale assessment (Normal, mild, mod, severe).
• Treatment naïve subjects diagnosed with ulcerative colitis (without previous exposure to treatment).
• \. UC patients already on a treatment might be considered, with saffron as an add-on 8. UC patients who displayed no improvement with any available treatment might be considered for saffron as an alternative treatment in this option.

You may not qualify if:

• Patients taking immunosuppressive medicine for a disease other than UC 2 Rheumatologic disease and other underlying diseases that can interfere with the study process.
• Pregnancy 4 If the UC has been present for \> 10 years, a colonoscopy with biopsy has to be performed to rule-out dysplasia.
• A subject who had surgery as a treatment for ulcerative colitis or likely to require surgery during the study period.
• Subjects with evidence of liver disease or abnormal liver enzymes and function tests (e.g. total bilirubin, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) higher than the upper limit of normal) at the screening visit.
• Subjects who have any condition possibly affecting oral nutritional supplement absorption.
• Patients with known active or untreated GI infections including C. difficile, CMV, HSV, HIV

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Minia University

Minya, Minya Governorate, 61111, Egypt

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

safranal

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Alshymaa Hassnine, Ass. prof

CONTACT

+201092004294; Alshiamaa.Ahmed@mu.edu.eg

Amr Elsayed, Ass. prof

CONTACT

+201092004294; amshi12@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associated prof

Study Record Dates

• First Submitted: January 19, 2023
• First Posted: February 6, 2023
• Study Start: March 30, 2023
• Primary Completion: May 30, 2023
• Study Completion: July 30, 2023
• Last Updated: March 17, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)