Myelodispelasia. Myelodysplastic syndrome, unspecified
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 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%
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Tehran University of Medical Sciences