Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04749576
Status:
UNKNOWN
Last Update Posted:
2021-02-11
First Post:
2020-12-09
Brief Title:
Saffron as Anti Inflammatory Agent In Patients With Inflammatory Bowel Disease
Sponsor:
Howard University
Organization:
Howard University
Study Overview
Official Title:
Efficacy of Nutritional Saffron Supplement As An Anti Inflammatory Agent In Patients With Inflammatory Bowel Disease
Status:
UNKNOWN
Status Verified Date:
2021-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Nutritional Saffron supplement has been widely used as food supplement and has known anti-depressant and anti-inflammatory activities It is generally consumed as stigmas in drinks or dishes The investigators use saffron extract in patients with colitis for 8 weeks
Detailed Description:
The patients invited to participate in a research study on Inflammatory Bowel Diseases IBD and saffron as a nutritional anti-inflammatory supplement
Inflammatory Bowel Disease IBD is composed of Crohns 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 patients status and decrease the need for immunosuppressants If participants have been prescribed immunosuppressants by the participants 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
Inflammatory Bowel Disease IBD is composed of Crohns 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 patients status and decrease the need for immunosuppressants If participants have been prescribed immunosuppressants by the participants 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None