The effect of melatonin in Ulcerative colitis

Evaluation of the effect of melatonin on clinical, biochemical parameters and quality of life in Ulcerative colitis patients

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20121021011192N9

Enrollment

Registered

2019-12-03

Start date

2019-05-22

Completion date

Unknown

Last updated

2019-12-17

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: Addition of melatonin tablet orally 3 mg/d to UC regimen for 3 months. Intervention 2: Control group: Addition of melatonin placebo tablet orally 3 mg/d to UC regim

Eligibility

Sex/Gender

All

Age

20 Years to No maximum

Inclusion criteria

Inclusion criteria: UC disease in patients with more than 20 years old

Exclusion criteria

Exclusion criteria: History of confirmed hypersensitivity reaction to melatonin or any parts of formulation eGFR less than 30 ml/min/1.73m2 Liver failure (child pugh B, C) Pregnancy & lactation Uncontrolled seizure & untreated major depressive disorder Concurrent use of fluvoxamine , nifedipine & non steroidal anti inflammatory drugs(NSAID)

Design outcomes

Primary

Measure	Time frame
Change in Fecal calprotectin level. Timepoint: Before intervention and 90 days after initiation of daily use of melatonin. Method of measurement: Lab kits.;Hange in high sensitivity CRP serum level. Timepoint: Before intervention and 90 days after initiation of daily use of melatonin. Method of measurement: Lab kits.;Change in Hemoglobin level. Timepoint: Before intervention and 90 days after initiation of daily use of melatonin. Method of measurement: Lab kits.;Improvement of clinical symptoms of uc. Timepoint: Before intervention and 90 days after initiation of daily use of melatonin. Method of measurement: Interview with patients based on Simple clinical colitis activity index questionnaire.;Improvement of quality of life. Timepoint: Before intervention and 90 days after initiation of daily use of melatonin. Method of measurement: Interview with patients based on SF36 questionnaire.	—

Measure

Time frame

Change in Fecal calprotectin level. Timepoint: Before intervention and 90 days after initiation of daily use of melatonin. Method of measurement: Lab kits.;Hange in high sensitivity CRP serum level. Timepoint: Before intervention and 90 days after initiation of daily use of melatonin. Method of measurement: Lab kits.;Change in Hemoglobin level. Timepoint: Before intervention and 90 days after initiation of daily use of melatonin. Method of measurement: Lab kits.;Improvement of clinical symptoms of uc. Timepoint: Before intervention and 90 days after initiation of daily use of melatonin. Method of measurement: Interview with patients based on Simple clinical colitis activity index questionnaire.;Improvement of quality of life. Timepoint: Before intervention and 90 days after initiation of daily use of melatonin. Method of measurement: Interview with patients based on SF36 questionnaire.

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Secondary

Measure	Time frame
Record of Adverse drug reactions. Timepoint: During intervention. Method of measurement: Interview with patients.	—

Countries

Iran (Islamic Republic of)

Contacts

Public Contactroja qobadi ghadikolaei

Shahid Beheshti University of Medical Sciences

roja.ghobadi@gmail.com+98 21 8887 3704

Outcome results

None listed

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