Health Condition 1: D570- Hb-SS disease with crisis
Conditions
Interventions
None listed
Sponsors
Central Council for Research in Ayurvedic Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1. confirmation of HbSS pattern by HPTLC 2. Participants must have the laboratory indices as defined below 2.a Hemoglobin level more than or equal to 6 g per dL at screening 2.b Platelet count more than or equal to 1,00,000 per L 2.c Sr. Creatinine less than or equal to 1.5 mg per dL or within the upper limit of normal 3. Clinically stable patient with or without ongoing standard care 4. Willing to participate and provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Participants with acute vaso-occlusive crisis, uncontrolled intercurrent illness, severe infection, or more than or equal to 5 SCD-related hospitalizations in the past year. 2. History of frequent or recent blood transfusions more than once every 3 months or within the last 60 days. 3. Presence of bleeding or coagulation disorders or use of chronic anticoagulant or antiplatelet therapy. 4. History of hematopoietic stem cell or solid organ transplantation. 5. Significant cardiovascular or neurological disease, including stroke within the past 2 years, coronary artery disease, arrhythmias, or congestive cardiac failure. 6. Uncontrolled hypertension BP more than or equal 160/100 mmHg with or without medication 7. Significant organ dysfunction, including renal impairment or hepatic dysfunction 8. Serious systemic or chronic illnesses, including known malignancy, HIV infection, or psychiatric illness. 9. Uncontrolled pulmonary disease, such as severe asthma, chronic obstructive pulmonary disease (COPD), or similar conditions. 10. Poorly controlled diabetes mellitus, defined as HbA1c more than or eual to 7%, with or without medication. 11. Gastrointestinal conditions affecting drug absorption, including inability to take oral medications or presence of malabsorption syndrome. 12. Active substance abuse or dependence. 13. Participation in another clinical trial during the study period 14. Women who are pregnant, lactating, or planning conception 15. Any other condition which, in the opinion of the Principal Investigator, may compromise participant safety or interfere with study conduct
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of the participants out of screened who adopted Ayurvedic treatment for SCDTimepoint: Screening Day 30,60,90,120,150,180 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in frequency of vaso-occlusive pain crises (VOC) during the intervention periodTimepoint: Screening Day 30,60,90,120,150,180;Change in pain intensity, measured using the Visual Analogue ScaleTimepoint: Screening Day 30,60,90,120,150,180;Change in frequency and duration of hospitalization due to SCD-related pain crisesTimepoint: Screening Day 30,60,90,120,150,180;Change in the requirement of analgesics/opioids for pain crisesTimepoint: Screening Day 30,60,90,120,150,180;Change in levels of inflammatory and hematological parameters, including C-reactive protein (CRP), lactate dehydrogenase (LDH), hemoglobin concentration (Hb%), hemoglobin fractions (HbS, HbF, HbA), and complete blood count parameters from baseline to the end of the studyTimepoint: Screening Day 30,60,90,120,150,180;Change in fatigue levels, assessed using the Modified Fatigue Impact ScaleTimepoint: Screening Day 30,60,90,120,150,180;Change in health-related quality of life, assessed using the SF-8 questionnaireTimepoint: Screening Day 30,60,90,120,150,180;Change in frequency of red blood cell (RBC) transfusions, if any, during the study periodTimepoint: Screening Day 30,60,90,120,150,180;Incidence of Adverse events/ ADR (with frequency and severity)Timepoint: Screening Day 30,60,90,120,150,180 | — |
Countries
India
Contacts
Public ContactDr Deepa Makhija
Central Council for Research in Ayurvedic Sciences
Outcome results
None listed