Investigating the effect of crocin in ulcerative colitis

Investigating the effect of crocin on metabolic indices, inflammatory biomarkers and oxidative stress factors in ulcerative colitis patients.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20240831062917N1

Enrollment

Registered

2024-09-11

Start date

2024-10-06

Completion date

Unknown

Last updated

2024-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative colitis. Ulcerative colitis

Interventions

Intervention 1: Intervention group: Patients receiving the standard treatment of mesalamine plus two daily capsules of crocin (Samisaz company) for 12 weeks, orally, each containing 15 mg of crocin su

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients with ulcerative colitis proven through clinical diagnosis and previous colonoscopy results with mild-to-moderate colitis Calprotectin and CRP positive and receiving standard treatment of mesalamine Adult patients from 18 years to 65 years. No use of other medicinal plants in the past 3 months. No allergy to saffron plant and its derivatives. Not taking new antidepressants and sleeping pills in the last 2 months. No use of new anti-inflammatory and antioxidant drugs in the last 3 months. Taking the usual medications prescribed by the doctor in the last 4 months.

Exclusion criteria

Exclusion criteria: Normal calprotectin and CRP. Pregnancy or breastfeeding. In case of any side effects. Anticoagulant and warfarin use. A history of other underlying diseases and autoimmune diseases. alcohol consumption Taking any anti-depressant, anti-inflammatory and new sleep medications in the last 2 months. Consumption of new anti-inflammatory and antioxidant drugs in the last 3 months. Change in commonly prescribed medications in the last 4 months.

Design outcomes

Primary

Measure	Time frame
Calprotectin. Timepoint: Before the intervention and 12 weeks after the intervention. Method of measurement: ELISA.;Nitric oxide (NO). Timepoint: Before the intervention and 12 weeks after the intervention. Method of measurement: Spectrophotometry.;Myeloperoxidase (MPO). Timepoint: Before the intervention and 12 weeks after the intervention. Method of measurement: Spectrophotometry.;Quantitative CRP. Timepoint: Before the intervention and 12 weeks after the intervention. Method of measurement: Turbidimetry.;Catalase. Timepoint: Before the intervention and 12 weeks after the intervention. Method of measurement: Spectrophotometry.;Malondialdehyde (MDA). Timepoint: Before the intervention and 12 weeks after the intervention. Method of measurement: Spectrophotometry.;Total antioxidant capacity (TAC). Timepoint: Before the intervention and 12 weeks after the intervention. Method of measurement: Spectrophotometry.;AMPK gen expression. Timepoint: Before the intervention and 12 weeks after the intervention. Method of measurement: Real-time PCR.;SIRT-1 gen expression. Timepoint: Before the intervention and 12 weeks after the intervention. Method of measurement: Real-time PCR.;GLUT1 gen expression. Timepoint: Before the intervention and 12 weeks after the intervention. Method of measurement: Real-time PCR.;PKM2 gen expression. Timepoint: Before the intervention and 12 weeks after the intervention. Method of measurement: Real-time PCR.;TNFa. Timepoint: Before the intervention and 12 weeks after the intervention. Method of measurement: ELISA.;IL-6. Timepoint: Before the intervention and 12 weeks after the intervention. Method of measurement: ELISA.;IL-1ß. Timepoint: Before the intervention and 12 weeks after the intervention. Method of measurement: ELISA.;Ulcerative colitis disease activity index in the Mayo clinic score questionnaire. Timepoint: Before the intervention and 12 weeks after the intervention. Method of measurement: Mayo clinic score questionnaire.;Cell Blood Coun	—

Measure

Time frame

Calprotectin. Timepoint: Before the intervention and 12 weeks after the intervention. Method of measurement: ELISA.;Nitric oxide (NO). Timepoint: Before the intervention and 12 weeks after the intervention. Method of measurement: Spectrophotometry.;Myeloperoxidase (MPO). Timepoint: Before the intervention and 12 weeks after the intervention. Method of measurement: Spectrophotometry.;Quantitative CRP. Timepoint: Before the intervention and 12 weeks after the intervention. Method of measurement: Turbidimetry.;Catalase. Timepoint: Before the intervention and 12 weeks after the intervention. Method of measurement: Spectrophotometry.;Malondialdehyde (MDA). Timepoint: Before the intervention and 12 weeks after the intervention. Method of measurement: Spectrophotometry.;Total antioxidant capacity (TAC). Timepoint: Before the intervention and 12 weeks after the intervention. Method of measurement: Spectrophotometry.;AMPK gen expression. Timepoint: Before the intervention and 12 weeks after the intervention. Method of measurement: Real-time PCR.;SIRT-1 gen expression. Timepoint: Before the intervention and 12 weeks after the intervention. Method of measurement: Real-time PCR.;GLUT1 gen expression. Timepoint: Before the intervention and 12 weeks after the intervention. Method of measurement: Real-time PCR.;PKM2 gen expression. Timepoint: Before the intervention and 12 weeks after the intervention. Method of measurement: Real-time PCR.;TNFa. Timepoint: Before the intervention and 12 weeks after the intervention. Method of measurement: ELISA.;IL-6. Timepoint: Before the intervention and 12 weeks after the intervention. Method of measurement: ELISA.;IL-1ß. Timepoint: Before the intervention and 12 weeks after the intervention. Method of measurement: ELISA.;Ulcerative colitis disease activity index in the Mayo clinic score questionnaire. Timepoint: Before the intervention and 12 weeks after the intervention. Method of measurement: Mayo clinic score questionnaire.;Cell Blood Coun

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Secondary

Measure	Time frame
Quality of life in ulcerative colitis. Timepoint: Before the intervention and 12 weeks after the intervention. Method of measurement: 32-question IBD Quality of life questionnaire ( IBD Q-32 ).;Triglycerides (TG). Timepoint: Before the intervention and 12 weeks after the intervention. Method of measurement: spectrophotometry.;Total cholesterol. Timepoint: Before the intervention and 12 weeks after the intervention. Method of measurement: spectrophotometry.;HDL-Cholesterols. Timepoint: Before the intervention and 12 weeks after the intervention. Method of measurement: spectrophotometry.;LDL-Cholesterol. Timepoint: Before the intervention and 12 weeks after the intervention. Method of measurement: Spectrophotometry.	—

Measure

Time frame

Quality of life in ulcerative colitis. Timepoint: Before the intervention and 12 weeks after the intervention. Method of measurement: 32-question IBD Quality of life questionnaire ( IBD Q-32 ).;Triglycerides (TG). Timepoint: Before the intervention and 12 weeks after the intervention. Method of measurement: spectrophotometry.;Total cholesterol. Timepoint: Before the intervention and 12 weeks after the intervention. Method of measurement: spectrophotometry.;HDL-Cholesterols. Timepoint: Before the intervention and 12 weeks after the intervention. Method of measurement: spectrophotometry.;LDL-Cholesterol. Timepoint: Before the intervention and 12 weeks after the intervention. Method of measurement: Spectrophotometry.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactShima Kabiri Arani

Esfahan University of Medical Sciences

sh_kabiri@yahoo.com+98 31 3792 7052

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026