Other Sickle-cell Disorders With Crisis, Unspecified Clinical Trial
Official title:
Antioxidant Effect of the Extract of Jobelyn (Sorghum Bicolor) on the Quality of Life of Patients With Sickle Cell Disease
The purpose of this study is to determine the antioxidant effect of prolonged use of sorghum bicolor (jobelyn) to increase the level of plasma superoxide dismutase and glutathione reductase in patients with sickle cell disease and to determine if there is any improvement in the quality of life of the patients.
Jobelyn is an extract of sorghum bicolor that is popular in Nigeria as a herbal food
supplement. This extract has been shown to have a high oxygen radical absorbance capacity
(ORAC 37,622micro mole TE/g) compared to other botanical preparations 1. A second proven
property is its anti inflammatory effect with a selective COX 2 inhibition 2. It has also
been shown to correct anaemia induced in experimental rabbit by trypanosome brucei brucei 3.
Jobelyn is being consumed as a herbal nutritional supplement in many disorders including
sickle cell disease in Nigeria without complaint in over 15 years. The toxicology profile is
impressive with a wide therapeutic range.
Nigeria is one of the countries with the largest burden of sickle cell disease. It is a
chronic genetic disorder that accounts for absenteeism at school and at work place. There is
also a significant shortening of the life span of the affected patients. Sickle cell anaemia
presents with recurrent bone pains and progressive organ damage that affects negatively the
quality of life of the patients. Available measures that have been in use include use of
hydroxyurea, chronic and acute red cell transfusion and haematopoietic stem cell
transplantation. These have limitations in terms of adverse effects, cost and availability.
The pathogenesis involves intracellular precipitation of the mutant haemoglobin, rigidity of
the cell, adhesion of cells to the endothelium. These cause recurrent tissue hypoxia and
reperfusion which cause release of reactive oxygen series and agents of inflammation. The
extract of sorghum is therefore expected to improve the quality of life of these patients.
Previous work done, have not investigated the long time effect of the extract on the quality
of life of sickle cell patients. This study is therefore designed to compare the quality of
life of patients on 500mg daily, 250mg daily and 2mg daily of jobelyn using adjusted
standard tools. The secondary outcomes to study are changes in indicators of inflammation
and systemic antioxidants in these patients. The study period is 12 months so that the
period shall involve all the weather conditions in the region.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment