Ulcerative ColitisPhase 4NCT05715099
Saffron as Anti Inflammatory In Patients With Inflammatory Bowel Disease
A Phase 4 study testing Saffron in people with Ulcerative Colitis, run by Minia University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Saffron
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Mar 2023to 30 Jul 2023
- Phase
- Phase 4
- 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 60 years
- All sexes
- Healthy volunteers accepted
- 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
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Minia University
Minya, Minya Governorate, 61111
Alshymaa Hassnine, Ass. prof, 01092004294, Alshiamaa.Ahmed@mu.edu.eg
Amr Elsayed, Ass. prof, +201092004294, amshi@yahoo.com
About this study
Official title: Efficacy of Nutritional Saffron Supplement as an Anti-inflammatory Agent in Egyptian Patients With Inflammatory Bowel Disease
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.
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, Placebo
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SaffronDrug
Also called safranal
Dietary Supplement: saffron supplement for IBD
PlaceboDrug
Dietary Supplement: placebo for IBD
| Study group | Role | What they receive |
|---|---|---|
| mild-moderate ulcerative colitis for low dose | Active comparator | 2 low dose (25 mg \dose) per day N= 20 Receives: Drug: Saffron |
| mild-moderate ulcerative colitis for high dose | Active comparator | 2 high dose (50 mg \dose) per day N=20 Receives: Drug: Saffron |
| healthy subjects for low dose | Active comparator | 2 low dose (25 mg \dose) per day N= 10 Receives: Drug: Saffron |
| healthy subjects for high dose | Active comparator | 2 high dose (50 mg \dose) per day N=10 Receives: Drug: Saffron |
| mild-moderate ulcerative colitis for placebo | Placebo comparator | 2 dose placebo per day N=20 Receives: Drug: Placebo |
| healthy subjects for placebo | Placebo comparator | 2 dose placebo per day N=10 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 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
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 posted6 Feb 2023
- Study start30 Mar 2023 (estimated)
- Primary completion30 May 2023 (estimated)
- Study completion30 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alshymaa Hassnine, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05715099
- Sponsor's protocol ID
- SaffronIBD
- Status last verified
- Mar 2023
- First submitted
- 19 Jan 2023
- Last updated
- 17 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. 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 Egyptian Patients With Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT05715099
- Acronym / sponsor ID
- SaffronIBD
- Conditions
- Ulcerative Colitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 30 Mar 2023 (estimated)
- Primary completion
- 30 May 2023 (estimated)
- Study completion
- 30 Jul 2023 (estimated)
- First posted
- 6 Feb 2023 (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. The investigators use saffron extract in Egyptian patients with ulcerative 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
- 6
| Arm | Type | Receives |
|---|---|---|
| mild-moderate ulcerative colitis for low dose | Active comparator | Drug: Saffron2 low dose (25 mg \dose) per day N= 20 |
| mild-moderate ulcerative colitis for high dose | Active comparator | Drug: Saffron2 high dose (50 mg \dose) per day N=20 |
| healthy subjects for low dose | Active comparator | Drug: Saffron2 low dose (25 mg \dose) per day N= 10 |
| healthy subjects for high dose | Active comparator | Drug: Saffron2 high dose (50 mg \dose) per day N=10 |
| mild-moderate ulcerative colitis for placebo | Placebo comparator | Drug: Placebo2 dose placebo per day N=20 |
| healthy subjects for placebo | Placebo comparator | Drug: Placebo2 dose placebo per day N=10 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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 (7 listed)
- 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.
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 |
|---|---|---|
| SaffronAlso: safranalDietary Supplement: saffron supplement for IBD | Drug | healthy subjects for high dose, healthy subjects for low dose, mild-moderate ulcerative colitis for high dose, mild-moderate ulcerative colitis for low dose |
| PlaceboDietary Supplement: placebo for IBD | Drug | healthy subjects for placebo, mild-moderate ulcerative colitis for placebo |
Primary outcome
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 weeks
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
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 17 Mar 2023.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Saffron in people with Ulcerative Colitis, run by Minia University at 1 site in Egypt.
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 7 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 17 Mar 2023. 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 Egypt. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Alshymaa Hassnine, Ass. prof (+201092004294, Alshiamaa.Ahmed@mu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fecal calprotectin assessment (time frame: 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Mar 2023.