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Dietary Supplement
Saffron for Inflammatory Bowel Disease
N/A
Waitlist Available
Research Sponsored by Howard University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8-12 weeks
Summary
This trial is testing saffron extract capsules to help reduce inflammation in patients with Inflammatory Bowel Disease (IBD). The goal is to see if saffron can lower the need for current treatments that have serious side effects. Saffron's anti-inflammatory properties may offer a safer alternative. Saffron has recently gained appreciable interest as a dietary supplement for its potential to reduce tissue inflammation and alter microbiome composition.
Eligible Conditions
- Colitis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8-12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8-12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
C reactive protein assessment
Serum Anti-inflammatory assessment
Serum Pro-inflammatory assessment
+6 moreSecondary study objectives
endoscopy colitis assessment
Trial Design
3Treatment groups
Active Control
Placebo Group
Group I: Low dose saffronActive Control1 Intervention
healthy, mild-moderate ulcerative colitis for low dose
Group II: High dose SaffronActive Control1 Intervention
healthy, mild-moderate ulcerative colitis for high dose
Group III: PlaceboPlacebo Group1 Intervention
healthy, mild-moderate ulcerative colitis for placebo
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Who is running the clinical trial?
Howard UniversityLead Sponsor
42 Previous Clinical Trials
14,889 Total Patients Enrolled
Hassan AshktorabStudy ChairHoward Uinversity
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are taking medication that weakens your immune system for a condition other than ulcerative colitis.You have a rheumatologic disease or other health conditions that may affect your ability to participate in the study.You have a condition that may make it difficult for your body to absorb oral nutritional supplements.If you have ulcerative colitis and are already receiving treatment, you may still be eligible if saffron is added to your current treatment.If you have ulcerative colitis and none of the existing treatments have helped you, you might be eligible to try saffron as a different treatment option.
Research Study Groups:
This trial has the following groups:- Group 1: Low dose saffron
- Group 2: High dose Saffron
- Group 3: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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