A single-centered pilot scale study to evaluate the safety and efficacy of orally administered supplement SJ29 Capsule in sickle cell anemia patients

Athulya Ayurvedic Medical Research Centre0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年7月22日

试验速览

暂无简介。

•1. Male or female over 18 to 30 years, both inclusive.
•2. non smokers.
•3. BMI greater than 18 kg/m2.
•4. Patients diagnosed with sickle cell disease (documented by hemoglobin electrophoresis) and carrying SS or Sbeta0 version of the beta globin gene (documented by genotyping, known through medical history).
•5. Hemoglobin levels between 5.5 and 10.5 g/dl during screening (for newly diagnosed or patients not on any treatment for SCD).
•6. If the patient has been treated with an anti-sickling agent within three months with the intent to continue for the duration of the study.
•7. Available to attend on an outpatient basis for visits provided for in the protocol and able to complete the data collection documents (compliance and quality of life scale)
•8. Patient or the patients legally authorized representative has given written informed consent.
•9. Able and willing to follow all study related instructions.
•10. Must be willing to give written informed consent and comply with the study procedures.

•1.Females who are pregnant or breastfeeding.
•2.Patient has a significant medical condition that required hospitalization (other than sickle cell crisis) within two months of the screening visit.
•3.Patient with diagnosed cancer in the past 2 years.
•4.Patients participating simultaneously in another clinical research protocol or having recently participated in another research for which the exclusion period has not been completed.
•5.Majors under legal protection or unable to express their consent.
•6.People in an emergency situation unable to express their prior consent.

发起方

Athulya Ayurvedic Medical Research Centre