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IRCT20130622013739N11 IRCT 2018-02-07 Tehran University of Medical Sciences Evaluation of the therapeutic efficacy of Mannuronic Acid in Myelodispelasia Comparing the effects of β-D-Mannuronic acid with Placebo in Myelodispelasia patients and related clinical and paraclinical parameters before and after treatment 2018-01-16 anticipated 28 Complete https://irct.ir/trial/28970 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In order to allocate the patients randomly into two groups of treatment and control, at first 7 blocks of 4 with C and T letters (The letters indicate the intervention and control groups) are created in each 2 patients are belonged to the intervention group and 2 patients are belonged to the control group). Then the blocks are randomly selected and arranged to obtain a sequential combination of 28 letters. Each letter will be placed in a sealed packet according to the obtained sequence, Blinding description: 28 patients over 18 years of age suffering from MDS are choose considering to inclusion criteria (patients who based on IPSS SCORE, be in high risk and intermediate group) in hematologic oncology clinic in first visit by oncologist. After filling the testimonial, the patients are divided to 2 control and treatment group in 1 to 1 form based on demographic information. The study will be done in random double blind form and neither patients nor investigator know the kind of consuming drug. 1-2 Myelodispelasia. Intervention 1: Intervention group (14 patients): This group will receive β-D-Mannuronic acid orally 1500 mg/day (three oral 500 mg tablets/day) which is produced from the decomposition of Alginate powder (a safe and natural substance used in food and pharmaceutical industries) for 12 weeks. It should be mentioned that Alginate powder is purchased from Sigma Corporation of U.S.A and β-D-Mannuronic acid is produced from it's decomposition in central laboratory of immunology department at School of Public Health and Institute of Health Research affiliated by Tehran University of Medical Sciences. Intervention 2: Control group (14 patients): will receive placebo with conventional drugs orally for 12 weeks. 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 isn't more information
public Dr. Abbas Mirshafiey
Department of Immunology, School of Public Health, Tehran University of Medical Sciences,16 Azar St ,Enghelab Sq, Tehran, Iran
Tehran Iran (Islamic Republic of) 14155-6446 +98 21 4293 3205 mirshafiey@tums.ac.ir Tehran University of Medical Sciences scientific Dr. Abbas Mirshafiey
Department of Immunology, School of Public Health, Tehran University of Medical Sciences,16 Azar St ,Enghelab Sq, Tehran, Iran
Tehran Iran (Islamic Republic of) 14155-6446 +98 21 4293 3205 mirshafiey@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients can be men and female Patients should be more than 18 years old Patients should be new case and their illness should be diagnosed during 3 month ago Risk grade based on IPSS SCORE in low risk or intermediated group should be IPSS low/int-1 risk 1 Patients should be able to fill the testimonial Function of liver and kidneys should be normal Patients who don't receive systemic therapies such as chemotherapy or radiotherapy The disorder should be pathological confirmation The number of blast cells in bone marrow should be less than 5% 18 years no limit Both Pregnant and Lactating women Enrolling in another clinical trial study within last 4 weeks Patients who based on IPSS SCORE, be in high risk and intermediate group Suffering from other concomitant diseases such as hepatic, renal, hematological, gastrointestinal, endocrine, cardiovascular, pulmonary, neurological or cerebral disease. D46.9 Myelodysplastic syndrome, unspecified Treatment - Drugs Placebo Intervention group (14 patients): This group will receive β-D-Mannuronic acid orally 1500 mg/day (three oral 500 mg tablets/day) which is produced from the decomposition of Alginate powder (a safe and natural substance used in food and pharmaceutical industries) for 12 weeks. It should be mentioned that Alginate powder is purchased from Sigma Corporation of U.S.A and β-D-Mannuronic acid is produced from it's decomposition in central laboratory of immunology department at School of Public Health and Institute of Health Research affiliated by Tehran University of Medical Sciences. Control group (14 patients): will receive placebo with conventional drugs orally for 12 weeks. The average of leukocytes number. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: Cell count by device. The average of hemoglobin amount. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: Computing by device. The average of platelets number. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: Cell count by device. The average of serum level of Lactate dehydrogenase. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: ELISA. The average of blast cells number in peripheral blood smear. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: Manual counting. Weakness. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: Taking history and Questionnaire. Fatigue. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: Taking history and Questionnaire. Frequent infections. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: Taking history and Questionnaire. Headache. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: Taking history and Questionnaire. Heart beat. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: Taking history and Questionnaire. Fever. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: Taking history and Questionnaire. Tehran University of Medical Sciences Approved 2018-01-08 Ethics commitee of Tehran Imam Khomeini hospital complex Gharib Ave, Keshavarz Blvd, Imam Khomeini hospital co Tehran Tehran Iran (Islamic Republic of)