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Evaluation of the therapeutic efficacy of Mannuronic Acid in Myelodispelasia

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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20130622013739N11
Enrollment
28
Registered
2018-02-07
Start date
2018-01-16
Completion date
Unknown
Last updated
2018-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myelodispelasia. Myelodysplastic syndrome, unspecified

Interventions

Intervention 1: Intervention group (14 patients): This group will receive ß-D-Mannuronic acid orally 1500 mg/day (three oral 500 mg tablets/day) which is produced from the decomposition of Alginate po

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

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

MeasureTime 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

MeasureTime 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

Public ContactDr. Abbas Mirshafiey

Tehran University of Medical Sciences

mirshafiey@tums.ac.ir+98 21 4293 3205

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 20, 2026