Evaluation of the therapeutic efficacy of Mannuronic Acid in Myelodispelasia

Phase 1

Recruiting

Conditions: Myelodispelasia.
Myelodysplastic syndrome, unspecified

Registration Number: IRCT20130622013739N11

Lead Sponsor: Tehran University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 28

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

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.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.