Health Condition 1: D570- Hb-SS disease with crisis
Conditions
Interventions
None listed
Sponsors
Sai Phytoceuticals (P) Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Sickle cell anemia (HbSS) patient confirmed by Hb electrophoresis in alkaline/acid media with moderate to severe recurrent episodes who had experienced at least 3 painful or vaso-occlusive crises since last year. Note: A painful vaso-occlusive crises is defined as an acute painful event requiring treatment at a healthcare facility or at home with either; (1) parental narcotics; or (2) an equianalgesic dose or oral narcotics; or (3) parenteral or equianalgesic dose of oral non-steroidal anti-inflammatory drugs (NSAID’S), and may include episodes of acute chest syndrome, splenic/hepatic sequestration or priapism 2. Both Male and Female patient 3. Ages: > 18 years and 4. Women of child bearing age willing to take contraceptive measure to prevent pregnancy during the study 5. Patients willing to give written informed consent
Exclusion criteria
Exclusion criteria: 1. Any acute Sickle cell events that require hospitalization within 1 month of enrollment. 2. Blood transfusion with-in 3 months of enrollment. 3. Symptoms other than sickle cell anemia. 4. Discovite/Hydroxyurea/NiprisanTM or any other anti-sckling drug/treatment use within 6 months of enrollment. 5. Severe illnesses like tuberculosis, cancer, cirrhosis of liver, aplastic anemia etc., also were excluded. 6. Patients with a history of hypersensitivity reaction 7. Patient unwilling or unable to follow the instruction regarding the treatment. 8. Active malignant disease or current cytostatic treatment 9. Known severe renal insufficiency 10. Pre-menopausal women who are pregnant or nursing, or are of child-bearing potential and are not practicing or do not plan to continue practicing acceptable methods of birth control 11. Patients with a history of chronic hepatitis B or C infection, HIV infection 12. Patients participating in any other clinical trial in the past 3 months. 13. AST & /or ALT > 3x upper limit of normal range or any sign of hepatic impairment or creatinine > 2x renal dysfunction. 14. QTc interval of > 470 msec at screening and patient with congenital long QT syndrome.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ? Changes in hemoglobin level ? Effect on hematological measurements like RBC count, reticulocyte count, mean corpuscular volume (MCV), mean corpuscular Hb concentration (MCHC), and mean corpuscular Hb (MCH) ? Effect on frequency, duration, and severity of painful crisis like vaso-occlusive crises, splenic sequestration crisis, aplastic crisis, acute sickle chest syndrome, and leg ulcers (as judged by validated pain scales, analgesia use, and hospital utilization)Timepoint: day 0, day 7, day 30, day 60 ,day 90. | — |
Secondary
| Measure | Time frame |
|---|---|
| ? Effect on liver & renal functioning, confirmed by various biochemical parameters ? Frequency of blood transfusion (change or absolute values) Protocol Number: ERS/SC/PMS23 Version 1.0 Date 16-MAY-2023 CONFIDENTIAL Page 30 of 37 ? Incidence of adverse events (clinical signs & symptoms) ? Quality of life measurement using WHO-QoLTimepoint: day0, day7, day 30,day 60,day90 | — |
Countries
India
Contacts
Public ContactSatyajeet Singh
Sai Phytoceuticals Pvt Ltd.
Outcome results
None listed