The effect of combination therapy of L-glutamine and hydroxyurea in patients with sickle cell anemia
- Conditions
- Sickle cell anemia, L-glutamine, hydroxyurea, pain crisis.Sickle-cell disorders, Sickle-cell anaemia with crisis, Sickle-cell anaemia without crisis, Double heterozygous sickling disorders, Sickle-cell trait, Other sickle-cell disorders
- Registration Number
- IRCT20210715051904N1
- Lead Sponsor
- Boushehr University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 126
Patients with sickle-cell syndrome
Age more than five-year-old
No other accompanying hematologic diseases
All patients should be on Hydroxyurea
At least two (extreme) pain crises have been documented in the past year (defining a pain crisis as pain that results from treatment with a drug or injectable ketorolac in the emergency department (ED) (or outpatient treatment center) or during hospitalization. Becomes)
Occurrence of life-threatening events not related to SCD during treatment
Patient dissatisfaction with participation in the study
Serum albumin levels are less than 3 g / dL
Internationally normalized ratios of prothrombin time are higher than 2.0
The treated with L-glutamine within 30 days prior to screening.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of pain crisis. Timepoint: Before intervention and 6 months after intervention. Method of measurement: Clinical examination by a pediatric hematologist and oncologist.;Number of hospitalizations for pain associated with sickle cell anemia. Timepoint: Before intervention and 6 months after intervention. Method of measurement: Clinical examination by a pediatric hematologist and oncologist.
- Secondary Outcome Measures
Name Time Method umber of Priapism event. Timepoint: Before intervention and 6 months after intervention. Method of measurement: Clinical examination by a pediatric hematologist and oncologist.;Number of acute chest syndrome. Timepoint: Before intervention and 6 months after intervention. Method of measurement: Clinical examination by a pediatric hematologist and oncologist.;Number of splenic sequestration events. Timepoint: Before intervention and 6 months after intervention. Method of measurement: Clinical examination by a pediatric hematologist and oncologist.