Evaluation of melatonin tablets in patients with beta thalassemia major
Not Applicable
- Conditions
- Thalassemia.?????????? ?????D56.1
- Registration Number
- IRCT20201212049684N1
- Lead Sponsor
- Mazandaran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 36
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
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.