Health Condition 1: D571- Sickle-cell disease without crisis
Conditions
Interventions
Intervention1: Hydroxyurea (less than or equal to 15mg per kg per day) plus L-Glutamine powder(micronized) 10gm twice a day (mfg by musclenecter) for 12 weeks: L-glutamine powder 10 g orally twice dai
Sponsors
All India Institute of Medical Sciences Nagpur
Eligibility
Inclusion criteria
Inclusion criteria: Patients eligible for the study include individuals of either gender who are above 18 years of age with a confirmed diagnosis of sickle cell anaemia characterized by the HbSS genotype. They must be on a stable low dose of hydroxyurea, defined as 15 milligrams per kilogram per day or less, for a minimum of three months prior to screening. Additionally, participants must be willing to provide written informed consent.
Exclusion criteria
Exclusion criteria: Patients will be excluded from the study if they are diagnosed with sickle cell trait or any hemoglobinopathies other than sickle cell anemia. Those with hepatic or renal impairment as indicated by laboratory reports will also be excluded. Additional exclusion criteria include receipt of blood products within eight weeks prior to screening, pregnancy or lactation, a known history of hypersensitivity to L-glutamine, or having received treatment with L-glutamine within thirty days before the screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in oxidative stress markers (baseline vs 12 weeks), including Total Gluathione/ Oxidized Glutathioneratio Malondialdehyde (MDA) Total antioxidant capacity (TAC) Timepoint: baseline vs 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of episodes of Pain episodes in both groups over 12 weeks Change in hemoglobin concentration, hematocrit, white blood cell (WBC) count, reticulocyte count, and lactate dehydrogenase (LDH) levels, compared between baseline and week 12 Number of adverse events as reported by patients or observed by physician and lab reports Change in quality of life score from baseline to week 12 using WHOQOL-BREF Timepoint: 12 weeks | — |
Countries
India
Contacts
Public ContactDr Tejesh K
All India Institute of Medical Sciences Nagpur
Outcome results
None listed