AzTrials
AzTrials

Ulcerative ColitisPhase 2NCT05117749

Saffron and Ulcerative Colitis

A Phase 2 study testing Saffron 100 and Saffron 50 in people with Ulcerative Colitis, run by Shiraz University of Medical Sciences.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Ulcerative Colitis
What is being tested?
Saffron 100 and Saffron 50
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
No sites listed yet
Study dates
May 2023to Aug 2025
Phase
Phase 2
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female patients between 18-80 years' old
  • Patients who have received a diagnosis of UC at least 3 months prior to screening. The diagnosis of UC must be confirmed by endoscopic and histologic evidence.
  • Patients with the ability to give written informed consent and to be compliant with the schedule of intervention and assessments
  • Patients with mild (3-5) or moderate (6-11) UC, according to the Simple Clinical Colitis Activity Index

Who cannot join

  • Pregnant patients or those planning pregnancy
  • Patients receiving immunosuppressive agents for diseases other than UC
  • Patients with confirmed cancer, dysplasia, autoimmune, and rheumatology diseases
  • Patients who had surgery for UC treatment
  • Individuals with liver disease or abnormal liver enzymes and function tests (e.g. total bilirubin, aspartate aminotransferase (AST) or alanine aminotransferase (ALT)) at the screening visit
  • Patients who have any condition affecting oral drug absorption.
  • Subjects with known active or untreated GI infections including C.diff, CMV, HSV, HIV
  • Subjects with clinical features of CD; history of CD (Crohns colitis, or Ileo-colitis), clinical signs of fulminant colitis, toxic megacolon, or Microscopic Colitis, indeterminate Colitis, infectious Colitis, or ischemic colitis

Trial locations and contacts

No sites are listed yet.

Ali Reza Safarpour, MD., Ph.D. contact

+98-7136281442

safarpourar@gmail.com

About this study

Official title: The Effect of Saffron in Patients With Ulcerative Colitis: A Randomized Double-blind Clinical Trial

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.

Read the detailed description

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:

  1. Mild UC patients, receiving100 milligram (mg)/day saffron for 8 weeks (50 mg two times (BID)), n=10
  2. Moderate UC patients, receiving100 mg/day saffron for 8 weeks (50 mg BID), n=10
  3. Mild UC patients, receiving 50 mg/day saffron for 8 weeks (25 mg BID), n=10
  4. Moderate UC patients, receiving 50 mg/day saffron for 8 weeks (25 mg BID), n=10
  5. Mild UC patients, receiving 2 tablets of placebo for 8 weeks, n=10
  6. Moderate UC patients, receiving 2 tablets of placebo for 8 weeks, n=10

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.

Being tested
Saffron 100, Saffron 50, Placebo
Keywords
saffron, Ulcerative Colitis, inflammatory bowel disease, randomized double-blind clinical trial
Medical subject headings
Colitis, Ulcerative, Inflammatory Bowel Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Saffron 100Drug

    to Mild and Moderate UC patients

  • Saffron 50Drug

    to Mild and Moderate UC patients

  • PlaceboDrug

    to Mild and Moderate UC patients

Study groups in NCT05117749
Study groupRoleWhat they receive
Mild UC-Saffron 100ExperimentalMild UC patients, receiving 100 milligram (mg)/day saffron for 8 weeks (50 mg two times (BID)), n=10
Receives: Drug: Saffron 100
Moderate UC-Saffron 100ExperimentalModerate UC patients, receiving100 mg/day saffron for 8 weeks (50 mg BID), n=10
Receives: Drug: Saffron 100
Mild UC-Saffron 50ExperimentalMild UC patients, receiving 50 mg/day saffron for 8 weeks (25 mg BID), n=10
Receives: Drug: Saffron 50
Moderate UC-Saffron 50ExperimentalModerate UC patients, receiving 50 mg/day saffron for 8 weeks (25 mg BID), n=10
Receives: Drug: Saffron 50
Mild UC-placeboPlacebo comparatorMild UC patients, receiving 2 tablets of placebo for 8 weeks, n=10
Receives: Drug: Placebo
Moderate UC-placeboPlacebo comparatorModerate UC patients, receiving 2 tablets of placebo for 8 weeks, n=10
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 4 and 8 weeks

  2. Changes in the fecal calprotectin level

    Measured: 4 and 8 weeks

  3. Changes in the serum levels of CRP

    Measured: 4 and 8 weeks

  4. Changes in the serum levels of ESR

    Measured: 4 and 8 weeks

Secondary outcomes (6)

  1. 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)

    Measured: 8 week

  2. 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).

    Measured: 8, 24, and 48 weeks

  3. 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.

    Measured: 8 week

  4. 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.

    Measured: 8 week

  5. 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).

    Measured: 8, 24, and 48 weeks

  6. 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

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Nov 2021
  2. Study startMay 2023 (estimated)
  3. Primary completionFeb 2025 (estimated)
  4. Study completionAug 2025 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Sixty eligible patients will be recruited and randomized into 6 groups to receive either saffron capsule or placebo.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05117749
Sponsor's protocol ID
24540
Status last verified
May 2022
First submitted
21 Oct 2021
Last updated
11 May 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Saffron 100 and Saffron 50 in people with Ulcerative Colitis, run by Shiraz University of Medical Sciences.

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 4 inclusion and 8 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 May 2022. Status can change between updates, so confirm with the study contact before making plans.

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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Ali Reza Safarpour, MD., Ph.D. (+98-7136281442, safarpourar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in clinical response (time frame: 4 and 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?

On the ClinicalTrials.gov record for NCT05117749.

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 May 2022.

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