A randomized, prospective, open label, parallel, active control, two arm,multicenter study to evaluate the efficacy and safety of Sailin-HbS™, aphytomedicine preparation, as an adjuvant treatment to standard of care inpatients suffering from sickle cell anemia - NI

Sai Phytoceuticals (P) Ltd0 个研究点目标入组 50 人开始时间: 待定最近更新: 2024年1月22日

试验速览

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•1.Sickle cell anemia (HbSS) patient confirmed by Hb electrophoresis in alkaline/acid media with moderate to severe recurrent episodes who had experienced at least 3 painful or vaso-occlusive crises since last year.
•Note: A painful vaso-occlusive crises is defined as an acute painful event requiring treatment at a healthcare facility or at home with either; (1) parental narcotics; or (2) an equianalgesic dose or oral narcotics; or (3) parenteral or equianalgesic dose of oral non-steroidal anti-inflammatory drugs (NSAID’S), and may include episodes of acute chest syndrome, splenic/hepatic sequestration or priapism
•2.Both Male and Female patient
•3.Ages: > 18 years and < 50 years
•4.Women of child bearing age willing to take contraceptive measure to prevent pregnancy during the study
•5.Patients willing to give written informed consent

•1.Any acute Sickle cell events that require hospitalization within 1 month of enrollment.
•2.Blood transfusion with-in 3 months of enrollment.
•3.Symptoms other than sickle cell anemia.
•4.Discovite/Hydroxyurea/NiprisanTM or any other anti-sckling drug/treatment use within 6 months of enrollment.
•5.Severe illnesses like tuberculosis, cancer, cirrhosis of liver, aplastic anemia etc., also were excluded.
•6.Patients with a history of hypersensitivity reaction
•7.Patient unwilling or unable to follow the instruction regarding the treatment.
•8.Active malignant disease or current cytostatic treatment
•9.Known severe renal insufficiency
•10.Pre-menopausal women who are pregnant or nursing, or are of child-bearing potential and are not practicing or do not plan to continue practicing acceptable methods of birth control
•11.Patients with a history of chronic hepatitis B or C infection, HIV infection
•12.Patients participating in any other clinical trial in the past 3 months.
•13.AST & /or ALT > 3x upper limit of normal range or any sign of hepatic impairment or creatinine > 2x renal dysfunction.
•14.QTc interval of > 470 msec at screening and patient with congenital long QT syndrome.

发起方

Sai Phytoceuticals (P) Ltd