Phase 1 Sickle Cell Disease Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You are between 18 and 70 years old.
• You have a confirmed diagnosis of sickle cell disease (one of these types: HbSS, HbSC, HbSβ+ or HbSβ0), proven by a specific blood test.
• You have not had a blood transfusion in the 60 days before signing the consent form, or your blood test shows no sign of transfused blood.
• Your liver enzyme levels (AST and ALT) are within an acceptable range, unless any elevation is due to your sickle cell disease breaking down red blood cells (confirm with trial site).
• Your hemoglobin (a measure of red blood cells) is at least 7 g/dL.
• Your kidney function is within an acceptable range, based on blood test results.
• If you take hydroxyurea, you have been on a stable dose for at least 90 days before signing the consent form.
• If you take L-glutamine and/or crizanlizumab, you have been on a stable dose for at least 90 days before signing the consent form.
• You agree not to take any products containing turmeric or curcumin (including supplements, foods, or topical products) for the entire duration of the study.
• If you are a woman who could become pregnant, you have a negative pregnancy test during screening.
• If you are a woman who could become pregnant, you agree to either abstain from sex or use 2 effective forms of contraception during the study and for 28 days after your last dose.
• You are willing and able to follow all study procedures for the full duration of the trial.
• You have signed a written consent form before any study procedures begin.

Who may not be able to join:

• You had a severe sickle cell pain crisis requiring IV or injected treatment within the 14 days before signing the consent form.
• You have had 3 or more sickle cell pain crises in the past 12 months that required treatment in an urgent care, clinic, emergency room, or hospital.
• You have high blood pressure that is not well controlled with medication (above 150/90 mmHg).
• You have had a serious heart or blood vessel problem in the past 24 weeks, such as heart failure, heart attack, stroke, or blood clots.
• You currently have painful gallstones or gallbladder inflammation (having had your gallbladder removed in the past is not a problem).
• You have a history of liver problems caused by a medication (drug-induced cholestatic hepatitis).
• You have severe iron build-up in your body that has caused damage to your heart, liver, or pancreas.
• You have active hepatitis B or hepatitis C infection.
• You have an active infection that requires antibiotic or antifungal treatment, or a severe infection within the past 4 weeks.
• You have diabetes that is poorly controlled or requires more than 3 different diabetes medications (using insulin alone does not automatically exclude you — confirm with trial site).
• You have a history of cancer, with some exceptions such as certain skin cancers, or cancers that were fully treated with no signs of return and no treatment in the last 3 years (confirm with trial site).
• You have a current or recent psychiatric condition that the study team believes could affect your ability to participate fully.
• You have previously had a bone marrow or stem cell transplant.
• You are currently taking part in another clinical trial involving an experimental or marketed treatment.
• You are currently taking nitroglycerin or any similar nitrate-based medication.
• You have used an experimental drug, device, or had an invasive medical procedure within the 12 weeks before signing the consent form.
• You are currently pregnant or breastfeeding.
• You are currently taking medications that stimulate blood cell production (such as erythropoietin), unless you stopped at least 90 days before signing the consent form.
• You have a known allergy to turmeric, curcumin, or related substances.

Important: Always verify eligibility with the trial site directly before applying.