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Evaluation of melatonin tablets in patients with beta thalassemia major

Evaluation of melatonin tablets in oxidative stress in patients with beta thalassemia major: A double blind placebo controlled, cross over clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20201212049684N1
Enrollment
36
Registered
2021-10-30
Start date
2021-11-22
Completion date
Unknown
Last updated
2021-11-01

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

Conditions

Thalassemia. ?????????? ?????

Interventions

Intervention 1: Intervention: Melatonin tablet 3 mg twice at night for 45 days. Intervention 2: Control group: Placebo tablet (twice at night) for 45 days.

Sponsors

Mazandaran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Beta thalassemia major Cases who are 18 years old or more Treatment with standard iron chelators at least for two years An unchanged treatment for 3 previous months before the beginning of the study Serum ferritin level higher than 1000 ng/dL Sleep quality index (PSQI)<5

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Estimating stress oxidative indexes as GSH,CAT,SOD and MDA. Timepoint: before treatment, at the end of Phase1 and at the end of the study. Method of measurement: Tests for oxidative stress with Spectrophotometry.

Secondary

MeasureTime frame
Improvement of quality of sleep. Timepoint: Before treatment, at the end of Phase1 and at the end of study. Method of measurement: PSQI- Pittsburgh Sleep Quality Index questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAmirhossein Sarkhosh

Mazandaran University of Medical Sciences

a.sarkhosh77@gmail.com+98 11 3354 3083

Outcome results

None listed

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