Ulcerative ColitisNCT04749576
Saffron as Anti Inflammatory Agent In Patients With Inflammatory Bowel Disease
A study testing saffron supplement for IBD in people with Ulcerative Colitis, run by Howard University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- saffron supplement for IBD
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2020to 10 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female patients aged >18 years
- Have UC diagnosed at least 3 months prior to screening? The diagnosis of UC must be confirmed by endoscopic and histologic evidence.
- Men and women of childbearing potential must agree to use adequate birth control measures during the study.
- Ability to provide written informed consent and to be compliant with the schedule of protocol assessments, treatment plan, laboratory tests, and other study procedures.
- UC patients with mild, mod, severity as assess by the 4 scale assessment (Normal, mild, mod, severe).
- 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.
Who cannot join
- Patients taking immunosuppressive medicine for a disease other than UC
- Rheumatologic disease and other underlying diseases that can interfere with the study process.
- Pregnancy
- If the UC has been present for > 10 years, a colonoscopy with biopsy has to be performed to rule-out dysplasia.
- A subject who had surgery as a treatment for ulcerative colitis or likely to require surgery during the study period.
- 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.
Show all 9Show fewer
- Subjects who have any condition possibly affecting oral nutritional supplement absorption.
- Any other condition which in the opinion of the investigators would make the subject unsuitable for inclusion in the study.
- Patients with known active or untreated GI infections including C. difficile, CMV, HSV, HIV
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Howard University Hospital
Washington D.C., District of Columbia, 20059
Hassan Ashktorab, 202-806-6121, hashktorab@howard.edu
Hassan Brim, 2028064198, hbrim@howard.edu
About this study
Official title: Efficacy of Nutritional Saffron Supplement As An Anti Inflammatory Agent In Patients With Inflammatory Bowel Disease
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.
Read the 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 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
- Ulcerative Colitis
- Being tested
- saffron supplement for IBD
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
saffron supplement for IBDDietary supplement
anti inflammatory effect
| Study group | Role | What they receive |
|---|---|---|
| Low dose saffron | Active comparator | healthy, mild-moderate ulcerative colitis for low dose Receives: Dietary Supplement: saffron supplement for IBD |
| High dose Saffron | Active comparator | healthy, mild-moderate ulcerative colitis for high dose Receives: Dietary Supplement: saffron supplement for IBD |
| Placebo | Placebo comparator | healthy, mild-moderate ulcerative colitis for placebo Receives: Dietary Supplement: saffron supplement for IBD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 weeks
stool frequency assessment
will be assessed by decreasing less than 2 per day
Measured: 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)
Measured: 8 week
fecal calprotectin assessment
Decrease in calprotectin levels. Fecal calprotectin normal range to be 10 to 60 μg/mg
Measured: 8 weeks
C reactive protein assessment
change on C reactive protein level reading is less than 10 milligram per liter
Measured: 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.
Measured: 8 weeks
Serum Pro-inflammatory assessment
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
Measured: 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
Measured: 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
Measured: 8 weeks
Secondary outcomes (1)
endoscopy colitis assessment
Secondary endpoints will be endoscopy remission at week 8-12 according to gastroenterologist preference
Measured: 8-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2021
- Study start15 Dec 2020
- Primary completion10 Dec 2021 (estimated)
- Study completion10 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomize double placebo
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Howard University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hassan Ashktorab, Study chair, Howard Uinversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04749576
- Sponsor's protocol ID
- HowardU
- Status last verified
- Jan 2021
- First submitted
- 9 Dec 2020
- Last updated
- 11 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: After completing the tials we will share the data
Publications
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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Nutritional Saffron Supplement As An Anti Inflammatory Agent In Patients With Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT04749576
- Acronym / sponsor ID
- HowardU
- Conditions
- Ulcerative Colitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Howard UniversityUniversity, hospital or other
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 10 Dec 2021 (estimated)
- Study completion
- 10 Dec 2023 (estimated)
- First posted
- 11 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- randomize double placebo
| Arm | Type | Receives |
|---|---|---|
| Low dose saffron | Active comparator | Dietary Supplement: saffron supplement for IBDhealthy, mild-moderate ulcerative colitis for low dose |
| High dose Saffron | Active comparator | Dietary Supplement: saffron supplement for IBDhealthy, mild-moderate ulcerative colitis for high dose |
| Placebo | Placebo comparator | Dietary Supplement: saffron supplement for IBDhealthy, mild-moderate ulcerative colitis for placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female patients aged >18 years
- Have UC diagnosed at least 3 months prior to screening? The diagnosis of UC must be confirmed by endoscopic and histologic evidence.
- Men and women of childbearing potential must agree to use adequate birth control measures during the study.
- Ability to provide written informed consent and to be compliant with the schedule of protocol assessments, treatment plan, laboratory tests, and other study procedures.
- UC patients with mild, mod, severity as assess by the 4 scale assessment (Normal, mild, mod, severe).
Key exclusion criteria (9 listed)
- Patients taking immunosuppressive medicine for a disease other than UC
- Rheumatologic disease and other underlying diseases that can interfere with the study process.
- Pregnancy
- If the UC has been present for > 10 years, a colonoscopy with biopsy has to be performed to rule-out dysplasia.
- A subject who had surgery as a treatment for ulcerative colitis or likely to require surgery during the study period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| saffron supplement for IBDanti inflammatory effect | Dietary supplement | High dose Saffron, Low dose saffron, Placebo |
Primary outcome
inflammatory markers assessment
Time frame: 8 weeks
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
stool frequency assessment
Time frame: 8 week
will be assessed by decreasing less than 2 per day
stool consistency assessment
Time frame: 8 week
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)
fecal calprotectin assessment
Time frame: 8 weeks
Decrease in calprotectin levels. Fecal calprotectin normal range to be 10 to 60 μg/mg
C reactive protein assessment
Time frame: 8 week
change on C reactive protein level reading is less than 10 milligram per liter
erythrocyte sedimentation rate assessment
Time frame: 8 weeks
maintaining erythrocyte sedimentation rate with the normal range of 0 to 22 mm/hr for men and 0 to 29 mm/hr for women.
Serum Pro-inflammatory assessment
Time frame: 8 weeks
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
Serum Anti-inflammatory assessment
Time frame: 8 weeks
improve the IL-10 level to at least reach the normal level of ranged from 4.8-9.8 pg/ml
The Ulcerative Colitis Colonoscopic Index of Severity scores
Time frame: 8 weeks
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
1 secondary outcome
endoscopy colitis assessment
Time frame: 8-12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
- Results publication1 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.
- Individual participant dataSharing planned: No. After completing the tials we will share the data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hassan Ashktorab study chair
Howard Uinversity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing saffron supplement for IBD in people with Ulcerative Colitis, run by Howard University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hassan Ashktorab (2028066121, hashktorab@howard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
inflammatory markers assessment (time frame: 8 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04749576, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2021; AzTrials last refreshed its copy on 6 Nov 2026.