Health Condition 1: D570- Hb-SS disease with crisis
Conditions
Interventions
None listed
Sponsors
Dhanvantari Clinic Ayurveda Health Care and Research Center
ATBU Harita Pharmaceuticals Pvt ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients between the ages above 07 to 55 years from both sexes from sickle hemoglobin. 2.Written informed parental/guardian consent and participant assent (where applicable) has been obtained per requirements, consistent with ICH guidelines. 3.Participant/Guardians must agree to adhere to Treatment guidelines. 4.Willingness to sign an informed written consent and comply with visit schedules. 5.Participants confirms of HBSS through HPLC 6. Participant who are confirmed Sickle cell anemia patients with positive microscopic sickle cell test, sickle cell solubility test. 7.Participants exhibit no other existing comorbidities 8.Participants having Negative Hepatitis B test. 9.Hemoglobin = 6.0 and = 11.0 g/dL during screening 10.Participants/Guardians agree to provide regular feedback and questionnaire during schedule visit 11. Participants having veg/non veg diet 12.Agrees not to participate in other clinical studies within 30 days after the last administration of the study treatment 13.Participant needs to be admitted to the ambulatory site for treatment of VOC requiring pain medication
Exclusion criteria
Exclusion criteria: 1.Participants not willing to participate 2.Participants having renal impairment 3.Participants not willing to visit clinic for schedule follow up. 4.Any other condition which the Principle Investigator thinks may jeopardize the study 5.Pregnant / lactating woman 6.Participants with unresolved infections or existing comorbidities. 7.Participants on any other treatment within 07 days of the first dose of study drug or who have not recovered from the side effects of such therapy 8.Participants have history of hospitalized treatment or blood transfusion before 15 days. 9.Participants taking any other then investigational drug in last 7 days 10.Participants who are allergic/Hypersensitivity reactions to herbal supplements and medications. 11.Participants who are unable to take and absorb oral medications, unable to swallow tablets. 12.Participants who are not able to understand and to comply with study instructions and requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Mean Change in Level of Red blood corpuscles in participants. 2. Mean Change in the Level of Types of Hemoglobin in participants. 3.Mean Change in various blood counts in participants.Timepoint: 1.Mean Change in Level of Red blood corpuscles in participants Measured by Laboratory analysis day 0, 15th, 120, and 180 day of schedule visit examination 2. Mean Change in the Level of Types of Hemoglobin in participants Measured by HPLC for HbS,HbF, and HbA on 0 day, and 180 day of schedule visit examination. 3.Mean Change in various blood counts in participants measured by Complete blood counts analysis day 0, 15th, 120, and 180 day of schedule visit examination | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Mean change in major and minor complaints in participants 2. Extent of reduction in pain score during ambulatory visit as assessed by the participant on a pain scale 3.Mean change in quality of life in participantsTimepoint: 1. Measure by Score and follow up visit examination 2. Measure by Pain scale and physical observation during schedule follow up visit examination 3. measure by Physical, laboratory values and quality of life questionnaire on scheduled visit examination | — |
Countries
India
Contacts
Public ContactDr Atul Desai
Dhanvantari Clinic, Ayurveda Healthcare and Research centre
Outcome results
None listed