Effect of Saffron supplementation on ulcerative colitis

The effect of Saffron supplementation on inflammatory markers and Quality of life in patients with Ulcerative Colitis

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20120415009472N18

Enrollment

100

Registered

2018-03-23

Start date

2018-04-03

Completion date

Unknown

Last updated

2018-03-26

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: Daily intake of one saffron tablet (100 mg) for 8 weeks (2 months). Intervention 2: Control group: ?Daily intake of one placebo tablet (containing maltodextrin) for

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: The willingness to voluntarily participate in the study The consumer of only one of the drug groups 5 -Amino salicylic acid (Pentasa, Mesalazine or Asacol), as well as azathioprine BMI greater than 18.5 and less than 30 The diagnosis of ulcerative colitis in the mild to moderate phase by the physician

Exclusion criteria

Exclusion criteria: Changing the type and dosage of the drug over the past month The incidence of other autoimmune diseases, cancer Pregnancy or lactation in women The use of multi vitamin-mineral supplements, antioxidants, and also the use of anticoagulants, blood cholesterol lowering drugs, anti-TNF drugs, and glucocorticosteroids over the past month Non-compliance with treatment (less than %80)

Design outcomes

Primary

Measure	Time frame
IL-10. Timepoint: Before the intervention and two months later of intervention. Method of measurement: Concentration of IL-10 in serum using ELISA kit.;NF-kB. Timepoint: Before the intervention and two months later of intervention. Method of measurement: NF-kB activity in peripheral blood cells.;Quality of Life. Timepoint: Before the intervention and two months later of intervention. Method of measurement: Using the IBDQ-9 questionnaire.;Hs-CRP. Timepoint: Before the intervention and two months later of intervention. Method of measurement: Concentration of IL-10 in serum using ELISA kit.;ESR. Timepoint: Before the intervention and two months later of intervention. Method of measurement: Westergern method.	—

Measure

Time frame

IL-10. Timepoint: Before the intervention and two months later of intervention. Method of measurement: Concentration of IL-10 in serum using ELISA kit.;NF-kB. Timepoint: Before the intervention and two months later of intervention. Method of measurement: NF-kB activity in peripheral blood cells.;Quality of Life. Timepoint: Before the intervention and two months later of intervention. Method of measurement: Using the IBDQ-9 questionnaire.;Hs-CRP. Timepoint: Before the intervention and two months later of intervention. Method of measurement: Concentration of IL-10 in serum using ELISA kit.;ESR. Timepoint: Before the intervention and two months later of intervention. Method of measurement: Westergern method.

—

Secondary

Measure	Time frame
Weight. Timepoint: Before the intervention and two months later of intervention. Method of measurement: Using the digital scale.;Body Mass Index. Timepoint: Before the intervention and two months later of intervention. Method of measurement: Using the ratio of weight (kilogram) to the square of height (meter).	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Naheed Aryaeian

Iran University of Medical Sciences

n-aryaeian@sina.tums.ac.ir+98 21 8670 4750

Outcome results

None listed

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