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IRCT20221102056386N1 IRCT 2023-03-03 Bandare-abbas University of Medical Sciences Investigating the effect of Q10 in thalassemia patients treated with Iron chelators Investigating the effect of Q10 on laboratory findings in thalassemia patients treated with Iron chelators: a double-blind clinical trial 2023-04-08 anticipated 86 Complete https://irct.ir/trial/67991 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Before starting the study, all participants will be explained that they will be divided into two intervention (A) and control (B) groups. In this trial, we had two groups of 4 blocks (including 2 participants in drug group A and 2 participants in placebo group B). Production tools are also used from random sequence generation software (random allocation software) that this sequence generation software gives items that are able to generate a random sequences by block building method on simple structures. Blocked randomization is for the purpose of making sure that precisely equal number of participants are included in the intervention and control group at consecutive but equal time intervals. The randomization process is done by methodology consultant and the clinical researchers are not aware of the randomization method. Concealment Allocation refers to the method used to perform a random sequence on participants in the study, in such a way that the allocated group is not known before the allocation of the individual. By using opaque and sealed envelopes with a random sequence (Sequentially numbered, seal, opaque envelopes), in this method, each of the random sequences created is recorded on a card, and the cards are placed inside the envelopes in order They are placed. In order to maintain a random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the letter envelopes is glued and placed in a box, Blinding description: In this study, blinding will be done for participants and researchers. In this way, the medicine and placebo will be placed in the same packages by a person outside the study, which will be labeled with A and B codes. The given codes will be provided to researchers after statistical analysis and when writing the article. To blind the participants and reduce their bias, it was explained to them only at the beginning of the study that they will receive one of two types of intervention and they will not be told the exact type of supplement. 3 Thalassemia. Intervention 1: Intervention group: Receiving 100 mg of Q10 tablets (Provided by Shari Pharmaceutical Company) daily for 3 months to thalassemia patients treated with Iron chelators. Intervention 2: Control group: Includes patients who receive 100 mg of placebo daily, which does not contain any type of intervention agent, for three months. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Dr Malihe Mohamadzade
Educational and Research Complex of the Great Prophet , Shahid Mohammadi Hospital, Jomhory Blvd, Old Airport, Bandar Abbas, Iran
Bandarabbas Iran (Islamic Republic of) 7919915519 +98 76 3371 0373 mohammadzadeh_aa@yahoo.com Bandare-abbas University of Medical Sciences scientific Dr Parvin Kamkar
Educational and Research Complex of the Great Prophet , Shahid Mohammadi Hospital, Jomhory Blvd, Old Airport, Bandar Abbas, Iran
BandarAbbas Iran (Islamic Republic of) 7919915519 +98 76 3334 7000 Pkamkar10@yahoo.com Bandare-abbas University of Medical Sciences Iran (Islamic Republic of) Patients with major and intermedia beta thalassemia disease History of taking Iron chelators regularly in the last three months Age between 2 and 65 years 2 years 65 years Both Having an active infection Existence of contraindications to the studied drugs D56 Thalassemia Treatment - Drugs Treatment - Drugs Intervention group: Receiving 100 mg of Q10 tablets (Provided by Shari Pharmaceutical Company) daily for 3 months to thalassemia patients treated with Iron chelators Control group: Includes patients who receive 100 mg of placebo daily, which does not contain any type of intervention agent, for three months Glomerular filtration rate. Timepoint: At the beginning and end of the third month of using Q10. Method of measurement: Autoanalyzer device. Blood Urea Nitrogen. Timepoint: At the beginning and end of the third month of using Q10. Method of measurement: Autoanalyzer device. Creatinine. Timepoint: At the beginning and end of the third month of using Q10. Method of measurement: Autoanalyzer device. Uric acid. Timepoint: At the beginning and end of the third month of using Q10. Method of measurement: Autoanalyzer device. Pr/Cr ratio. Timepoint: At the beginning and end of the third month of using Q10. Method of measurement: Autoanalyzer device. Side effects of the studied drugs, especially those such as hypersensitivity reactions, allergies, shock, anemia, hypotension, nausea and vomiting, diarrhea, gastrointestinal spasms, weakness and lethargy, headache, and rash. Timepoint: Side effects are recorded daily in the studied groups. Method of measurement: Examining patients' files and using checklists. Improvement of biochemical parameters of patients (Complete blood count tests, ferritin, C-reactive protein, aspartate aminotransferase, alanine transaminase, uric acid, lipid profile, albumin, fasting blood sugar). Timepoint: Beginning of study and end of study. Method of measurement: Use of cell counter and autoanalyzer device. Bandare-abbas University of Medical Sciences Approved 2022-12-18 Ethics committee of Hormozgan University of Medical Sciences Imam Hossein Blvd., Hormozgan University of Medical Sciences Campus, Research and Technology Vice-Chancellor Building Bandarabbas Hormozgan Iran (Islamic Republic of)