Health Condition 1: D571- Sickle-cell disease without crisis
Conditions
Interventions
Intervention1: Hydroxyurea (less than or equal to
15mg per kg per day) plus LGlutamine powder(micronized)
10gm twice a day (mfg by
musclenecter) for 12 weeks: L-glutamine powder 10 g orally twice
dail
Sponsors
Dr Chaitali Chindhalore
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patient of either gender of age more than 18 years not exceeding 60 years 2.Confirmed diagnosis of sickle cell anaemia (HbSS genotype) 3.On stable low-dose hydroxyurea (less than or equal to 15 mg per kg per day) for at least 3 months before screening 4.Patients Willing to provide written informed consent
Exclusion criteria
Exclusion criteria: 1.Patients diagnosed with sickle cell trait and other hemoglobinopathies apart from sickle cell anemia 2.Patients suffering from hepatic or renal impairment based on Lab reports 3.Patient received blood products within 8 weeks before screening 4.Pregnant or lactating women 5.Known history of hypersensitivity to L-glutamine 6.Patient received treatment with l glutamine within 30 days before the screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Absolute and percent change in plasma IL-6 concentration from baseline to Week 12. 2.Absolute and percent change in plasma TNF-alpha concentration from baseline to Week 12 Timepoint: baseline to Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Number of pain episodes in both groups over 12 weeks 2.Change in hemoglobin concentration, hematocrit, white blood cell (WBC) count, reticulocyte count, and lactate dehydrogenase (LDH) levels, from baseline to 12 weeks 3.Correlation between change in cytokines (IL-6 and TNF-alpha) and change in hematological markers (Hb, hematocrit, LDH, reticulocyte count) from baseline to Week 12 (both absolute and percent change). 4.Regression estimates of the association between cytokine changes and hematologic outcomes e.g., change in Hb, reticulocyte count, LDH (dependent) per unit decrease in IL-6 or TNF-alpha (independent), adjusted for baseline values and key covariates. Timepoint: 12 weeks | — |
Countries
India
Contacts
Public ContactDr Chaitali Chindhalore
All India Institute of Medical Sciences, Nagpur
Outcome results
None listed