Health Condition 1: D57- Sickle-cell disorders
Conditions
Interventions
Intervention1: Hydroxyurea plus individualized homoeopathic medicine in 50 millesimal (LM) potencies: Standard care with fixed dose hydroxyurea plus individualized homoeopathic medicine prescribed in
Sponsors
Central Council for Research in Homoeopathy
Eligibility
Inclusion criteria
Inclusion criteria: 1.Diagnosed cases of sickle cell disease confirmed by Hemoglobin electrophoresis or HPLC demonstrating HbSS or compound heterozygote SCD (HbS/BO-thalassaemia). 2.At least one vaso-occlusive pain episode requiring medical attention in the 12 months prior to screening. 3. On stable standard of care for more than 3 months prior to randomizationor not on disease modifying therapy but willing to continue standard care per treating physician. 4.Able and willing to provide written informed consent and to comply with all study procedure, follow up visits and sample collections. 5.Willing to provide biological samples(blood and saliva) for hematological, immunological and metabolomic analyses. 6.For women of childbearing potential: negative pregnancy test at screening and agreement to use effective contraception throughout the study period.
Exclusion criteria
Exclusion criteria: 1.Receipt of a blood transfusion within 12 weeks prior screening. 2.Current enrolment in another interventional clinical trial, or participation in an interventional trial within the past 3 months. 3.Chronic transfusion program (regularly scheduled transfusion for stroke prevention or other indications) that cannot be safely interrupted or that will confound outcome assessment. 4.Any major organ dysfunction defined as: severe renal impairment or hepatic transaminases more than 3x of normal limit or NYHA class 3 or 4 heart failure 5.Known active infection requiring systemic antimicrobial therapy. 6.Pregnant or breastfeeding women 7.Use of chronic systemic immunosuppressive therapy within 3 months prior to screening. 8.Known hypersensitivity or allergy to any components of the study medication or placebo. 9.Any hematologic malignancy, other active malignancy, or other serious medical or psychiatric condition that in the opinion of the investigator would make participation unsafe or would prevent compliance with the protocol or completion of follow-up. 10.Inability or unwillingness to attend scheduled visits, complete study questionnaires(ASCQ-Me) or provide required sample. 11.Prior hematopoietic stem cell transplant or planned stem cell transplant during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in VOC severity and duration:Mean pain intensity measuredby VAS during VOC episodes(patient-reported). Hematological parameters: Changes in Hemoglobin(g/dL),HbF(%),Reticulocyte count(%). Transfusion requirements:Numberofpacked RBC transfusion per participant and proportion of participant requiring transfusion during follow-up. Number of hospital admissions, total inpatient days, ED visits and outpatient visits related to SCD per participant year.Timepoint: baseline,6month,12month,18month,24month | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Quality of life (ASCQ-Me): Change in ASCQ-Me domain scores and overall summary score. 2.Absenteeism: Total opioid/analgesic doses, number of missed work/school days(daily wages loss estimate) during each assessment window. 3.Pedigree/Genetic documentation(exploratory): Completion rate of pedigrees, proportion with confirmed family members affected, and any correlations between family history and clinical/biomarker outcomes.Timepoint: Baseline, 6 months, 12 months, 18 months, 24 months | — |
Countries
India
Contacts
Public ContactDr Divya Taneja
Central Council for Research in Homoeopathy
Outcome results
None listed