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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose saffron | Active Comparator | healthy, mild-moderate ulcerative colitis for low dose |
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| High dose Saffron | Active Comparator | healthy, mild-moderate ulcerative colitis for high dose |
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| Placebo | Placebo Comparator | healthy, mild-moderate ulcerative colitis for placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| saffron supplement for IBD | Dietary Supplement | anti inflammatory effect |
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| Measure | Description | Time Frame |
|---|---|---|
| inflammatory markers assessment | Serum anti-inflammatory and pro-inflammatory markers measures in 8 weeks compared to baseline improving the blood immune marker in the normal range for contributing factors which consist of TNF-α (8.1 pg/mL).IL-1β (<5 pg/mL), IL-6(5-15 pg/ml)., and IL-10 (4.8-9.8 pg/ml), The units in the parenthesis are the normal range for each marker | 8 weeks |
| stool frequency assessment | will be assessed by decreasing less than 2 per day | 8 week |
| stool consistency assessment | Improvement to median score 4 to normal stool consistency. Bristol score: Improvement in stool consistency measures in 8 weeks in our study compared to baseline (Bristol score: The ideal stool is generally type 3 or 4, easy to pass without being too watery too solid. Type 1 or 2, it is sign of constipation. Types 5, 6, and 7 tend toward diarrhea) | 8 week |
| 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 week |
| 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 |
| Serum Pro-inflammatory assessment |
| Measure | Description | Time Frame |
|---|---|---|
| endoscopy colitis assessment | Secondary endpoints will be endoscopy remission at week 8-12 according to gastroenterologist preference | 8-12 weeks |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hassan Ashktorab | Contact | 2028066121 | hashktorab@howard.edu | |
| Hassan Brim | Contact | 2028064198 | hbrim@howard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Hassan Ashktorab | Howard Uinversity | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Howard University Hospital | Recruiting | Washington D.C. | District of Columbia | 20059 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 1 Ghosh S, Mitchell R. Impact of inflammatory bowel disease on quality of life: Results of the European Federation of Crohn's and Ulcerative Colitis Associations (EFCCA) patient survey J Crohns Colitis. 2007;1:10-20. 2 Jess T, Gamborg M, Munkholm P, Sorensen TI. Overall and cause-specific mortality in ulcerative colitis: meta-analysis of population-based inception cohort studies Am J Gastroenterol. 2007;102:609-617. 3 Tanaka T. Colorectal carcinogenesis: Review of human and experimental animal studies J Carcinog. 2009;8:5. 4 Torres J, Burisch J, Riddle M, Dubinsky M, Colombel JF. Preclinical disease and preventive strategies in IBD: perspectives, challenges and opportunities Gut. 2016;65:1061-1069. 5 Dahlhamer JM, Zammitti EP, Ward BW, Wheaton AG, Croft JB. Prevalence of Inflammatory Bowel Disease Among Adults Aged >/=18 Years - United States, 2015 MMWR Morb Mortal Wkly Rep. 2016;65:1166-1169. 6 Nguyen DL, Parekh N, Bechtold ML, Jamal MM. National Trends and In-Hospital Outcomes of Adult Patients With Inflammatory Bowel Disease Receiving Parenteral Nutrition Support JPEN J Parenter Enteral Nutr. 2016;40:412-416. 7 Kappelman MD, Rifas-Shiman SL, Porter CQet al. . Direct health care costs of Crohn's disease and ulcerative colitis in US children and adults Gastroenterology. 2008;135:1907-1913. 8 Blakeley-Ruiz JA, Erickson AR, Cantarel BLet al. . Metaproteomics reveals persistent and phylum-redundant metabolic functional stability in adult human gut microbiomes of Crohn's remission patients despite temporal variations in microbial taxa, genomes, and proteomes Microbiome. 2019;7:18. 9 Ashktorab H, Soleimani A, Singh Get al. . Saffron: The Golden Spice with Therapeutic Properties on Digestive Diseases Nutrients. 2019;11. 10 Mashmoul M, Azlan A, Khaza'ai H, Yusof BN, Noor SM. Saffron: A Natural Potent Antioxidant as a Promising Anti-Obesity Drug Antioxidants (Basel). 2013;2:293-308. 11 Hosseinzadeh H, Talebzadeh F. Anticonvulsant evaluation of safranal and crocin from Crocus sativus in mice Fitoterapia. 2005;76:722-724. 12 Hosseinzadeh H, Modaghegh MH, Saffari Z. Crocus sativus L. (Saffron) extract and its active constituents (crocin and safranal) on ischemia-reperfusion in rat skeletal muscle Evid Based Complement Alternat Med. 2009;6:343-350. 13 El-Maraghy SA, Rizk SM, Shahin NN. Gastroprotective effect of crocin in ethanol-induced gastric injury in rats Chem Biol Interact. 2015;229:26-35. 14 Hosseinzadeh H, Sadeghnia HR. Safranal, a constituent of Crocus sativus (saffron), attenuated cerebral ischemia induced oxidative damage in rat hippocampus J Pharm Pharm Sci. 2005;8:394-399. 15 Lee IA, Lee JH, Baek NI, Kim DH. Antihyperlipidemic effect of crocin isolated from the fructus of Gardenia jasminoides and its metabolite Crocetin Biol Pharm Bull. 2005;28:2106-2110. 16 Abdullaev FI, Espinosa-Aguirre JJ. Biomedical properties of saffron and its potential use in cancer therapy and chemoprevention trials Cancer Detect Prev. 2004;28:426-432. 17 Abdullaev FI. Cancer chemopreventive and tumoricidal properties of saffron (Crocus sativus L.) Exp Biol Med (Maywood). 2002;227:20-25. 18 Singh G, Brim H, Ashktorab H, Habtezion A. Protective effect of Saffron in mouse model colitis through immune modulation DDW Gasteroenrology, City;2020. 19 Yoshino F, Yoshida A, Umigai N, Kubo K, Lee MC. Crocetin reduces the oxidative stress induced reactive oxygen species in the stroke-prone spontaneously hypertensive rats (SHRSPs) brain J Clin Biochem Nutr. 2011;49:182-187. 20 Rahaiee S, Moini S, Hashemi M, Shojaosadati SA. Evaluation of antioxidant activities of bioactive compounds and various extracts obtained from saffron (Crocus sativus L.): a review J Food Sci Technol. 2015;52:1881-1888. 21 Hosseinzadeh H, Younesi HM. Antinociceptive and anti-inflammatory effects of Crocus sativus L. stigma and petal extracts in mice BMC Pharmacol. 2002;2:7. . 34 Maleki I, Taghvaei T, Barzin M, Amin K, Khalilian A. Validation of the Persian version of the inflammatory bowel disease questionnaire (IBDQ) in ulcerative colitis patients Caspian J Intern Med. 2015;6:20-24. 35 McGahuey CA, Gelenberg AJ, Laukes CAet al. . The Arizona Sexual Experience Scale (ASEX): reliability and validity J Sex Marital Ther. 2000;26:25-40. 36 Brim H, Yooseph S, Lee Eet al. . A Microbiomic Analysis in African Americans with Colonic Lesions Reveals Streptococcus sp.VT162 as a Marker of Neoplastic Transformation Genes (Basel). 2017;8. 37 Tabtabaei S, D'Archivio AA, Maggi MAet al. . Geographical classification of Iranian and Italian saffron sources based on HPLC analysis and UV-Vis spectra of aqueous extracts Eur Food Res Technol. 2019;245:2435-2446. |
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After completing the tials we will share the data
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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randomize double placebo
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Both patients and care provider does not know whether the participant receiving placebo or saffron
improving the blood immune marker in the normal range for contributing factors which consist of TNF-α (8.1 pg/mL).IL-1β (<5 pg/mL), IL-6(5-15 pg/ml)., IL-10 (4.8-9.8 pg/ml), and Th17 (221.6±90.2/µl). The units in the parenthesis are the normal range for each marker |
| 8 weeks |
| Serum Anti-inflammatory assessment | improve the IL-10 level to at least reach the normal level of ranged from 4.8-9.8 pg/ml | 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 |
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |