Effect of melatonin versus placebo on serum levels of oxidative stress biomarkers and clinical outcomes in patients with septic shock

Effect of melatonin versus placebo on serum levels of oxidative stress biomarkers and clinical outcomes in patients with septic shock: a double-blind randomized clinical trial

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20120215009014N296

Enrollment

Registered

2019-09-15

Start date

2019-09-23

Completion date

Unknown

Last updated

2019-10-07

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

Conditions

Septic shock. Severe sepsis with septic shock

Interventions

Intervention 1: Intervention group: Routine treatment plus oral melatonin 50 mg made by Sepidteb Pharmaceutical Factory daily for 5 days through a nasogastric tube. Intervention 2: Control group: Rout

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Age of 18 to 65 years Septic shock

Exclusion criteria

Exclusion criteria: Pregnancy or breastfeeding Contraindication of intestinal nutrition Using other antioxidants or anti-inflammatory drugs Liver or renal chronic diseases

Design outcomes

Primary

Measure	Time frame
Catalase activity. Timepoint: Before the intervention and on the second, third, fourth and fifth days after the intervention. Method of measurement: Using laboratory Kit special for catalase.;Superoxide dismutase activity. Timepoint: Before the intervention and on the second, third, fourth and fifth days after the intervention. Method of measurement: Using laboratory Kit special for superoxide dismutase.;Glutathione peroxidase activity. Timepoint: Before the intervention and on the second, third, fourth and fifth days after the intervention. Method of measurement: Using laboratory Kit special for glutathione peroxidase.;Malondialdehyde activity. Timepoint: Before the intervention and on the second, third, fourth and fifth days after the intervention. Method of measurement: Using laboratory Kit special for malondialdehyde.;Occurence of death. Timepoint: Up to the fifth day after the intervention. Method of measurement: By clinical observation.;Duration of mechanical ventilation. Timepoint: Up to the fifth day after the intervention. Method of measurement: By clinical observation.;Duration of hospitalization. Timepoint: Up to the fifth day after the intervention. Method of measurement: By clinical observation.;Average dose of vasopressor. Timepoint: Up to the fifth day after the intervention. Method of measurement: By clinical observation.	—

Measure

Time frame

Catalase activity. Timepoint: Before the intervention and on the second, third, fourth and fifth days after the intervention. Method of measurement: Using laboratory Kit special for catalase.;Superoxide dismutase activity. Timepoint: Before the intervention and on the second, third, fourth and fifth days after the intervention. Method of measurement: Using laboratory Kit special for superoxide dismutase.;Glutathione peroxidase activity. Timepoint: Before the intervention and on the second, third, fourth and fifth days after the intervention. Method of measurement: Using laboratory Kit special for glutathione peroxidase.;Malondialdehyde activity. Timepoint: Before the intervention and on the second, third, fourth and fifth days after the intervention. Method of measurement: Using laboratory Kit special for malondialdehyde.;Occurence of death. Timepoint: Up to the fifth day after the intervention. Method of measurement: By clinical observation.;Duration of mechanical ventilation. Timepoint: Up to the fifth day after the intervention. Method of measurement: By clinical observation.;Duration of hospitalization. Timepoint: Up to the fifth day after the intervention. Method of measurement: By clinical observation.;Average dose of vasopressor. Timepoint: Up to the fifth day after the intervention. Method of measurement: By clinical observation.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactD Abbas Taher

Hamedan University of Medical Sciences

t_anesthesia@yahoo.com+98 81 3364 0030

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 21, 2026