Clinical Trial: The Efficacy of Jobelyn (Sorghum Bicolor Extract)in the Treatment of Sickle Cell Anemia
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: The Effect of Jobelyn ( Extract of Sorghum Bicolor) on the Haematological Parameters of Patients With Sickle Cell Anaemia Disease.
Brief Summary: The primary objective is to determine if there is a significant increase in the haematocrit value of patients on Jobelyn and standard therapy compared to those on standard therapy alone.
Detailed Summary:
Sickle cell anaemia is an inherited haemoglobinopathy caused by a point missense mutation (GAG to GTG) in the beta globin gene that resulted in the substitution of an acidic amino acid ( glutamic acid) with a neutral and hydrophobic amino acid (valine) in the codon 6 of the beta globin chain. This genetic defect has a prevalence of 20% to 40% in Sub Saharan Africa, 7.8% in African Americans and to a lesser extent in the Middle East, Mediterranean and India.
The higher frequency in the sub Saharan Africa is thought to be due to the selective advantage the gene confers on the traits (heterozygotes state) in malaria zone. Nigeria is the most populous country in this region with about 24% frequency of the mutant gene. The prevalence of sickle cell anaemia in Nigeria is about 20 per 1000 life births. This implies that Nigeria may have the highest burden of the disease in the world.
The severity of sickle cell disease varies. The disease is more severe in patients with haemoglobin SS or haemoglobin S beta thalassaemia than in those with haemoglobin S beta+ thalassaemia or haemoglobin SC disease. The Arab - Indian haplotype produces a less severe disease than the African haplotype. Similarly, the coinheritance of one or two, alpha globin chain deletions or high fetal haemoglobin level in hereditary persistence of fetal haemoglobin are associated with mild disease, The severity is therefore higher in the Sub Saharan African sub region. However, the severity of the disease varies widely for unexplained reasons among patients with haemoglobin SS in this region.
The beta S globin chain binds at the valine site with complementary hydrophobic effects on other beta globin chain. This triggers the formation of polymers of haemoglobin. The rate of polymerization is increased with increase
Sponsor: Lagos State University
Current Primary Outcome: Number of Participants with Adverse Events [ Time Frame: 12 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome: number of blood transfusions during the 12-week trial period [ Time Frame: 12 weeks ]
Original Secondary Outcome: Same as current
Information By: Lagos State University
Dates:
Date Received: October 3, 2012
Date Started: January 2012
Date Completion:
Last Updated: October 5, 2012
Last Verified: October 2012
