Ayurvedic intervention for prevention of acute pain crises in Sickle Cell Anaemia

Phase 3

• Conditions: Health Condition 1: D648- Other specified anemias

• Registration Number: CTRI/2023/04/052141
• Lead Sponsor: Central Council for Research in Ayurvedic Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

i)Must have sickle cell anemia confirmed by hemoglobin electrophorosis analysis with HbSS

ii) Participants must have the laboratory indices as defined below:

•Hemoglobin > 6 g/dL

•Platelets > 100,000/mcL

•Serum creatinine = 1.5 mg/dL or upper normal limit

•INR =2.0, PTT = 48 seconds

iii)Express willingness to adhere to the trial procedures and follow-up schedule

iv)Willing to give written informed consent

Exclusion Criteria

1.5 or more hospitalizations for pain in the last 12 months

2.Receiving regularly scheduled transfusions more than once in every 3 months

3.History of a bleeding diathesis

4.History of clinically overt stroke within 2 years

5.Receiving chronic anti-coagulation or anti-platelet therapy

6.Have previously undergone a hematopoietic stem cell transplant or solid organ transplant

7.Red cell transfusion within 60 days

8.Patients who have a past history of Cardiac Arrhythmia, Acute Coronary Syndrome, Myocardial Infarction and Stroke.

9.Symptomatic patients with clinical evidence of congestive cardiac failure.

10.Chronic liver disease or two times upper limit of normal level of ALT/AST

11.Patients having BP = 160/100 mmhg.

12.Clinically significant infection episodes.

13.Unable to take oral medications or having malabsorption syndrome.

14.Active substance abuse.

15.Patients with concurrent Renal Dysfunction (defined as S. creatinine > 1.5 mg/dl.

16.Uncontrolled Pulmonary Dysfunction (asthmatic and COPD patients) or other concurrent severe disease.

17.Known cases of Hepatitis.

18.Patients with HBA1C - = 8.

19.Known cases of HIV and AIDS.

20.Known cases of malignancy.

21.Patients of Hyperthyroidism.

22.Patient taking participation in any other clinical trial.

23.Women who are planning for conception / pregnant or lactating.

24.Any other condition which the P.I. thinks may jeopardize the study.

25.Heterozygous sickle cell trait (AS pattern).

26.Evidence of severe sickle-cell crisis.

Study & Design

• Study Type: Interventional
• Study Design: Not specified