Saffron as Anti Inflammatory In Patients With Inflammatory Bowel Disease
NCT ID: NCT05715099
Last Updated: 2023-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE4
90 participants
INTERVENTIONAL
2023-03-30
2023-07-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Saffron as Anti Inflammatory Agent In Patients With Inflammatory Bowel Disease
NCT04749576
Saffron and Ulcerative Colitis
NCT05117749
Bio-enhanced Curcumin as an Add-on Treatment in Maintaining Remission of Ulcerative Colitis
NCT02683759
Bio-enhanced Curcumin as an Add-On Treatment in Mild to Moderate Ulcerative Colitis
NCT02683733
Biologics in Management of Inflammatory Bowel Disease in Egyptian Patients
NCT05720221
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Inflammatory Bowel Disease (IBD) is composed of Crohn's Disease (CD) and Ulcerative Colitis (UC). Continuous altered immune responses and inflammation associate with this disease. More than two-thirds of patients reported that IBD-associated symptoms negatively affected their quality of life and their performance at work.
* Patients with IBD are generally put on immunosuppressants (that block or slow participants' immune system to lower the level of inflammation). Long-term use of these immunosuppressants have some serious side effects.
* The goal of this protocol is to lower the need for these immunosuppressants by giving saffron as capsules in two different doses. The investigators will assess whether the addition of saffron will improve the overall patient's status and decrease the need for immunosuppressants. If participants have been prescribed immunosuppressants by the participant's doctor, saffron will be added to the participants' treatment.
* The investigators request that the subject answer as many questions as they can during this visit. If they are unable to complete the questionnaires during this visit, the investigators ask them to please return them within 7 days. If the investigators do not receive the questionnaires, the investigators will make one phone call to remind the subjects to send the questionnaires back.
* The subject medical record and colonoscopy report will be used to determine IBD or health status, the blood sample will be used to assess immune markers (inflammatory and antiinflammatory), stool sample will be used to assess some inflammation markers and saffron effect on the intestinal bacterial composition, a saliva sample will be used to assess whether saffron selectively affects the intestinal bacteria but not the saliva bacteria and the urine sample will be used to assess saffron release in body fluids.
* Participants are being asked to participate in this research project because participants are having a normal colonoscopy for screening, or IBD.
* If a biopsy is taken at colonoscopy. a pathologist will use a portion to make a diagnosis. The investigators are requesting permission to use a portion of the excess tissue that the pathologist does not need, for this research project.
* Samples will be collected at baseline (day 0) and 8 weeks later after saffron capsules utilization.
* This is a double-blind clinical trial, you will not know whether participants are given a placebo (capsule without saffron) or saffron dose 1 or 2. This is important for participants and for the study process, to avoid any psychological effect on the expected saffron effect.
* However, by the end of the 8 weeks and after collecting and analyzing the data from all participants, the investigators will inform the subject of what the subjects were given and potential next steps.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
mild-moderate ulcerative colitis for low dose
2 low dose (25 mg \\dose) per day N= 20
Saffron
Dietary Supplement: saffron supplement for IBD
mild-moderate ulcerative colitis for high dose
2 high dose (50 mg \\dose) per day N=20
Saffron
Dietary Supplement: saffron supplement for IBD
healthy subjects for low dose
2 low dose (25 mg \\dose) per day N= 10
Saffron
Dietary Supplement: saffron supplement for IBD
healthy subjects for high dose
2 high dose (50 mg \\dose) per day N=10
Saffron
Dietary Supplement: saffron supplement for IBD
mild-moderate ulcerative colitis for placebo
2 dose placebo per day N=20
Placebo
Dietary Supplement: placebo for IBD
healthy subjects for placebo
2 dose placebo per day N=10
Placebo
Dietary Supplement: placebo for IBD
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Saffron
Dietary Supplement: saffron supplement for IBD
Placebo
Dietary Supplement: placebo for IBD
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Have UC diagnosed at least 3 months prior to screening? The diagnosis of UC must be confirmed by endoscopic and histologic evidence.
3. Men and women of childbearing potential must agree to use adequate birth control measures during the study.
4. Ability to provide written informed consent and to be compliant with the schedule of protocol assessments, treatment plan, laboratory tests, and other study procedures.
5. UC patients with mild, mod, severity as assess by the 4 scale assessment (Normal, mild, mod, severe).
6. Treatment naïve subjects diagnosed with ulcerative colitis (without previous exposure to treatment).
7\. 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.
Exclusion Criteria
3 Pregnancy 4 If the UC has been present for \> 10 years, a colonoscopy with biopsy has to be performed to rule-out dysplasia.
5 A subject who had surgery as a treatment for ulcerative colitis or likely to require surgery during the study period.
6 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.
7 Subjects who have any condition possibly affecting oral nutritional supplement absorption.
8 Any other condition which in the opinion of the investigators would make the subject unsuitable for inclusion in the study.
9 Patients with known active or untreated GI infections including C. difficile, CMV, HSV, HIV
18 Years
60 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Minia University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Alshymaa Hassnine
associated prof
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Minia University
Minya, Minya Governorate, Egypt
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SaffronIBD
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.