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The effect of combination therapy of L-glutamine and hydroxyurea in patients with sickle cell anemia

Efficacy of combination therapy of L-glutamine and Hydroxyurea in comparison with Hydroxyurea alone in patients with sickle cell anemia: a randomized, double-blinded clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20210715051904N1
Enrollment
126
Registered
2022-02-19
Start date
2022-02-14
Completion date
Unknown
Last updated
2025-08-19

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

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

Interventions

Intervention 1: Intervention group: Intervention group: The allocation of two randomized block blinds is encoded in numbered envelopes and is prepared according to the number of samples and will be pr

Sponsors

Boushehr University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 Years to No maximum

Inclusion criteria

Inclusion criteria: 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)

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Number 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

MeasureTime frame
Number 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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNader Shakibazad

Boushehr University of Medical Sciences

shakibn@bpums.ac.ir+98 77 3335 1048

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026