A Phase 2 interventional study of Saffron 100 and Saffron 50 in Ulcerative Colitis, sponsored by Shiraz University of Medical Sciences. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-05-11.
Sponsored by Shiraz University of Medical Sciences · Phase 2, Interventional, and Treatment
IBD is a chronic disease with two major types of Crohn's Disease (CD) and Ulcerative Colitis (UC). Nowadays, synthetic drugs and monoclonal antibodies are the most common types of drugs used for IBD management. However, due to their side effects and the high relapse rate, many researchers are looking for plant-derived products to manage the disease. Saffron, Crocus sativus L., is widely used as spice and medicine with anti-obesity, anticonvulsant, anti-hyperlipidemic, anti-tumor, antioxidant, and anti-inflammatory properties. Besides, there is evidence of the favorable effects of saffron on the gut microbiome. The main aim of this proposal is to evaluate the effect of saffron as a complementary supplement or add-on therapy in combination with current therapeutic agents in patients with mild and moderate UC.
This study will be a parallel, randomized, double-blinded clinical trial assessing the efficacy of the saffron extract compared to placebo in patients with mild and moderate UC. Sixty eligible patients will be recruited and randomized into 6 groups to receive either saffron capsule or placebo. Randomization will be performed by an independent researcher (AAK) who is not directly involved in the trial and using software-generated random permuted blocks. Allocation concealment will be also conducted using sealed, opaque envelopes with consecutive numbering. The saffron and placebo will be provided free of charge by Sina Pajoohan Salamat co, Mashhad, Iran. The standard treatment will be administered to all patients as recommendations of the physicians.
Intervention
The intervention groups of study will be included:
Demographic and baseline characteristics will be recorded, and assessment of anthropometric and biochemical parameters, fecal calprotectin, inflammatory cytokines, stool microbiome, and its transcriptomic, and metabolomic, urine and saliva metabolomics, health-related quality of life (HRQoL), anxiety, and disease severity will be done at baseline and after 8 weeks. Fecal calprotectin, C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), and disease severity will also be evaluated at 4th week. Moreover, HRQoL and anxiety will also be examined after 6 and 12 months.
1,853 studies on the registry are indexed under Colitis, Ulcerative; 472 are open to participants now.
This study's planned enrollment of 60 is below the median of 70 across 1,236 interventional studies indexed under Colitis, Ulcerative.
Browse Colitis, Ulcerative studies →Shiraz University of Medical Sciences is the lead sponsor of 130 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Mild UC patients, receiving 100 milligram (mg)/day saffron for 8 weeks (50 mg two times (BID)), n=10
Drug: Saffron 100
Moderate UC patients, receiving100 mg/day saffron for 8 weeks (50 mg BID), n=10
Drug: Saffron 100
Mild UC patients, receiving 50 mg/day saffron for 8 weeks (25 mg BID), n=10
Drug: Saffron 50
Moderate UC patients, receiving 50 mg/day saffron for 8 weeks (25 mg BID), n=10
Drug: Saffron 50
Mild UC patients, receiving 2 tablets of placebo for 8 weeks, n=10
Drug: Placebo
Moderate UC patients, receiving 2 tablets of placebo for 8 weeks, n=10
Drug: Placebo
to Mild and Moderate UC patients
to Mild and Moderate UC patients
to Mild and Moderate UC patients
Changes in clinical response
Changes in clinical response will be assessed by "Simple Clinical Colitis Activity Index", which has a total score between 0 to 19. Higher scores are interpreted to higher disease activity (worse outcome).
Time frame: 4 and 8 weeks
Changes in the fecal calprotectin level
Time frame: 4 and 8 weeks
Changes in the serum levels of CRP
Time frame: 4 and 8 weeks
Changes in the serum levels of ESR
Time frame: 4 and 8 weeks
Changes in the serum anti-inflammatory and pro-inflammatory markers
IL-1, IL-6, IL-10, IL-13RA2, IL18, IL17, TREM1, TNF- α, TNFR2, and oncostatin M (pg/ml)
Time frame: 8 week
Changes in the Health-related quality of life (HRQoL )
Changes in HRQoL will be assessed by a questionnaire, which has a total score between 9 to 63. Higher scores are interpreted to a higher quality of life (better outcome).
Time frame: 8, 24, and 48 weeks
Changes in the stool microbiome and transcriptome
Stool samples will be collected and after RNA extraction, reverse transcriptase qPCR will be performed. Small RNA sequencing libraries will also be constructed and16S rRNA gene analysis will be conducted.
Time frame: 8 week
Safety assessment (Incidence of Treatment-Emergent Adverse Events)
Any adverse events such as Gastrointestinal disorders, Psychiatric disorders, Nervous system disorders, and Immune system disorders will be assessed by the Common Terminology Criteria for Adverse Events Questionnaire.
Time frame: 8 week
Changes in the anxiety
Changes in anxiety will be assessed by Beck questionnaire, which has a total score between 0 to 63. Higher scores are interpreted to higher anxiety (worse outcome).
Time frame: 8, 24, and 48 weeks
Changes in the metabolomic profile of urine, stool, and saliva
Nuclear magnetic resonance will be used for assessment of the metabolomic profile of urine, stool, and saliva
Time frame: 8 weeks
No study locations are listed for this record.
Start is estimated for May 2023; primary completion for Feb 2025, 21 months later.
Of 44 non-industry phase 2 interventional studies under Colitis, Ulcerative, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 62. This study's planned 21 months is below that.
Counting every sponsor, half of 153 studies reached it within 28 months; a quarter within 22 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Shiraz University of Medical Sciences →