Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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 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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mild-moderate ulcerative colitis for low dose | Active Comparator | 2 low dose (25 mg \dose) per day N= 20 |
|
| mild-moderate ulcerative colitis for high dose | Active Comparator | 2 high dose (50 mg \dose) per day N=20 |
|
| healthy subjects for low dose | Active Comparator | 2 low dose (25 mg \dose) per day N= 10 |
|
| healthy subjects for high dose | Active Comparator | 2 high dose (50 mg \dose) per day N=10 |
|
| mild-moderate ulcerative colitis for placebo | Placebo Comparator | 2 dose placebo per day N=20 |
|
| healthy subjects for placebo | Placebo Comparator | 2 dose placebo per day N=10 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saffron | Drug | Dietary Supplement: saffron supplement for IBD |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| endoscopy colitis assessment | Secondary endpoints will be endoscopy remission at week 8-12 according to gastroenterologist preference | 8-12 weeks |
Not provided
Inclusion Criteria:
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:
1 Patients taking immunosuppressive medicine for a disease other than UC 2 Rheumatologic disease and other underlying diseases that can interfere with the study process.
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
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alshymaa Hassnine, Ass. prof | Contact | +201092004294 | Alshiamaa.Ahmed@mu.edu.eg | |
| Amr Elsayed, Ass. prof | Contact | +201092004294 | amshi12@yahoo.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Minia University | Minya | Minya Governorate | 61111 | Egypt |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C087963 | safranal |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo | Drug | Dietary Supplement: placebo for IBD |
|
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |