Clinical study on ayurvedic treatment as add on to Hydroxyurea in the management of Sickle cell disease

Prospective, Randomized, Open-Label, Blinded End Point exploratory clinical study to evaluate the efficacy and safety of Ayurvedic regimen as an adjunct to Hydroxyurea in the management of Sickle cell disease

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/03/051032

Enrollment

100

Registered

2023-03-23

Start date

Unknown

Completion date

Unknown

Last updated

2023-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: D571- Sickle-cell disease without crisis

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Diagnosed cases of Sickle Cell Disease (SCD) based on haemoglobin electrophoresis or HPLC 2. Age more than 18 years. 3. Any gender 4. Sickle cell (HbS) more than 60% 5. Patients who were not on Hydroxyurea since last 4 month. 6. History of at least 1 SCD related painful crisis per year over the 3 years prior to enrolment. 7. Hemoglobin >=5 g/dL, Platelets > 100,000/mcL, ALT (SGPT) INR

Exclusion criteria

Exclusion criteria: 1. Patients in acute vaso-occlusive crisis, uncontrolled intercurrent illness or any serious infection requiring hospitalization. 2. 10 or more hospitalizations for SCD related painful crisis in the last 12 months 3. History of severe coronary artery disease, uncontrolled hypertension and/or diabetes, severe chronic obstructive pulmonary disease, renal or hepatic dysfunction, malignancy, HIV or any other chronic life-threatening disease. 4. Neurologic dysfunction or severe psychiatric disorder. 5. Pregnant or breast-feeding 6. History of a bleeding diathesis, or receiving anti-coagulation or anti-platelet therapy 7. Previously undergone hematopoietic stem cell transplant or solid organ transplant

Design outcomes

Primary

Measure	Time frame
1.HbS, HbF, HbA 2.Complete Blood count [Hemoglobin, RBC count, WBC (count/mm3), Platelet count (count/mm3), MCHC (gm/dl), MCH (pg/cell), MCV (fl/cell), PCV (%), Neutrophil (%), Eosinophil (%), Lymphocytes (%), Monocytes (%), Reticulocyte count (%), Absolute reticulocyte count] 3.Frequency, severity and duration of painful crisis (on the basis of Visual analogue score (VAS), Brief Pain Inventory (BPI), days with home analgesic use. Timepoint: Clinical assessments at Screening, Baseline, Every 15 days for the first four months of the treatment period, Every 30 days until the end of the treatment period. Objective Parameters Assessments at Screening/ Baseline, During Treatment i.e., at the end of 4 months (16 weeks), During Treatment i.e., at the end of 8 months (32 weeks)	—

Measure

Time frame

1.HbS, HbF, HbA 2.Complete Blood count [Hemoglobin, RBC count, WBC (count/mm3), Platelet count (count/mm3), MCHC (gm/dl), MCH (pg/cell), MCV (fl/cell), PCV (%), Neutrophil (%), Eosinophil (%), Lymphocytes (%), Monocytes (%), Reticulocyte count (%), Absolute reticulocyte count] 3.Frequency, severity and duration of painful crisis (on the basis of Visual analogue score (VAS), Brief Pain Inventory (BPI), days with home analgesic use. Timepoint: Clinical assessments at Screening, Baseline, Every 15 days for the first four months of the treatment period, Every 30 days until the end of the treatment period. Objective Parameters Assessments at Screening/ Baseline, During Treatment i.e., at the end of 4 months (16 weeks), During Treatment i.e., at the end of 8 months (32 weeks)

—

Secondary

Measure	Time frame
1. Change in the health relatedquality of life (assessed through Short Form-8questionnaire) 2. Change in the level of Lactate dehydrogenase (LDH) 3. Change in the level of Inflammatory Markers - IL-6, IL-8, CRP, TGF-beta 4. Changes in subjective parameters likegeneral weakness, palpitation, myalgia, headache, backache, abdominal pain, anorexia ( as per VAS score) 5. Change in objective parameters likeIcterus, Pallor, Hepato-Splenomegaly, Facial Puffiness, Pyrexia 6. Assessment of Fatigue (Modified Fatigue Impact Scale) 7. Time duration (in days/month) for first vaso-occlusive crisis 8. Frequency of hospitalization for acute crisis 9. Frequency of blood transfusion required. 10. Incidence of Adverse events 11. Change in LFT, RFT and Urine- routine & microscopic examination Timepoint: â?¢ Clinical assessments at ï?¼ Screening ï?¼ Baseline ï?¼ Every 15 days for the first four months of the treatment period ï?¼ Every 30 days until the end of the treatment period. â?¢ Objective Parameters Assessments at ï?¼ Screening/ Baseline ï?¼ During Treatment i.e., at the end of 4 months (16 weeks) ï?¼ During Treatment i.e., at the end of 8 months (32 weeks)	—

Measure

Time frame

1. Change in the health relatedquality of life (assessed through Short Form-8questionnaire) 2. Change in the level of Lactate dehydrogenase (LDH) 3. Change in the level of Inflammatory Markers - IL-6, IL-8, CRP, TGF-beta 4. Changes in subjective parameters likegeneral weakness, palpitation, myalgia, headache, backache, abdominal pain, anorexia ( as per VAS score) 5. Change in objective parameters likeIcterus, Pallor, Hepato-Splenomegaly, Facial Puffiness, Pyrexia 6. Assessment of Fatigue (Modified Fatigue Impact Scale) 7. Time duration (in days/month) for first vaso-occlusive crisis 8. Frequency of hospitalization for acute crisis 9. Frequency of blood transfusion required. 10. Incidence of Adverse events 11. Change in LFT, RFT and Urine- routine & microscopic examination Timepoint: â?¢ Clinical assessments at ï?¼ Screening ï?¼ Baseline ï?¼ Every 15 days for the first four months of the treatment period ï?¼ Every 30 days until the end of the treatment period. â?¢ Objective Parameters Assessments at ï?¼ Screening/ Baseline ï?¼ During Treatment i.e., at the end of 4 months (16 weeks) ï?¼ During Treatment i.e., at the end of 8 months (32 weeks)

—

Countries

India

Contacts

Public ContactDr Danish Javed

All India Institute of Medical Sciences, Bhopal

danish.ayush@aiimsbhopal.edu.in9654978285

Outcome results