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IRCT20201212049684N1 IRCT 2021-10-30 Mazandaran University of Medical Sciences 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 2021-11-22 anticipated 36 Complete https://irct.ir/trial/53081 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Crossover, Purpose: Basic scienece, Randomization description: Block Randomization method is used to randomized the patients. For randomization, we visited the www.sealedenvelope.com, then randomization tab and make a list option were selected, the number of intervention groups, sample size, block size (4) were entered the intended locations, then a random list containing the pattern of patient allocation was obtained in two groups, Blinding description: Placebo has been made by pharmaceutics department of the pharmacy faculty of Mazandaran University of Medical Sciences, Iran as completely similar to the medication (Melatonin). The bottles (containing the medication or placebo) will be handed in eligible patients by the thalassemia ward's drugstore according to the random allocation list. Patients, physicians, the responsible of the drugstore and the thalassemia ward's nurses will be blind of the groups. Unique codes will be utilized instead of the alphabet to blind the groups. N/A Thalassemia. 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. Yes - There is a plan to make this available What will be shared: Informations according to main consequences can be shared When: available after publishing of the results To whom: Academic staff and general population Conditions: students and the researchers of thallassemia center can refer to documents and assaying their analysis Where to obtain: Can be referred to executive of the project or the correspondence of the article or the manager of the thallassemia center How to obtain: referring to published article or contact with e-mail or phone with the executive or manager of the center during 2 or 3 days it would be possible for availability to documents Comments:
public Amirhossein Sarkhosh
Km18, Khazarabad road,Payambar Azam buildings,Mazandaran University of Medical Sciences,Pharmacy School
Sari Iran (Islamic Republic of) 4847193698 +98 11 3354 3083 a.sarkhosh77@gmail.com Mazandaran University of Medical Sciences scientific Ramin Ataee
Km 18 Khazarabad ,Payambar Azam building, Mazandaran University of Medical Sciences ,Pharmacy School
Sari Iran (Islamic Republic of) 4847193698 +98 11 3354 3083 raminataee1349@gmail.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) 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 18 years 80 years Both D56.1 بتاتالاسمی ماژور Treatment - Drugs Treatment - Drugs Intervention: Melatonin tablet 3 mg twice at night for 45 days Control group: Placebo tablet (twice at night) for 45 days 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. 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. Mazandaran University of Medical Sciences Approved 2020-07-22 Ethics committee of Mazandaran University of Medical Sciences Km 18 Khazarabad road ,Payambar Azam assmbely ,Mazandaran University of Medical Sciences,Pharmacy School,Sari,Iran Sari Mazandaran Iran (Islamic Republic of)