Comparing the effects of β-D-Mannuronic acid with Placebo in Myelodispelasia patients and related clinical and paraclinical parameters before and after treatment

The main target of this study is to assess the safety and efficacy of β-D-Mannuronic acid in patients suffering from Myelodispelasia syndrome.

In this study which is a phase 1-2 clinical-trial, 28 patients suffering from MDS and qualify the inclusion criteria of study are choosen. 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 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.

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 of Tehran Imam Khomeini hospital complex 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.

Inclusion criteria: 1) Patients can be men and female , 2) Patients should be more than 18 years old , 3) Patients should be new case and their illness should be diagnosed during 3 month ago , 4) Risk grade based on IPSS SCORE in low risk or intermediated group should be IPSS low/int-1 risk 1 , 5) Patients should be able to fill the testimonial Function of liver and kidneys should be normal , 6) Patients who don't receive systemic therapies such as chemotherapy or radiotherapy , 7) The disorder should be pathological confirmation , 8) The number of blast cells in bone marrow should be less than 5% Exclusion criteria: 1) Pregnant and Lactating women , 2) Enrolling in another clinical trial study within last 4 weeks , 3) Patients who based on IPSS SCORE, be in high risk and intermediate group , 4) Suffering from other concomitant diseases such as hepatic, renal, hematological, gastrointestinal, endocrine, cardiovascular, pulmonary, neurological or cerebral disease.

Treatment group (14 patients) will receive β-D-Mannuronic acid orally 1500 mg/day (three 500 mg tablets/day) with conventional drugs and Control group (14 patients) ) will receive placebo with conventional drugs orally for 12 weeks.

The average of leukocytes number; The average of hemoglobin amount; The average of platelets number; The average of serum level of Lactate dehydrogenase; The average of blast cells number in peripheral blood smear

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.

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.