Clinical trial NCT01704794: Quality of Life Study for Sickle Cell Patients Treated With Jobelyn (Sorghum Bicolor Extract)
Official title: Antioxidant Effect of the Extract of Jobelyn (Sorghum Bicolor) on the Quality of Life of Patients With Sickle Cell Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Other Sickle-cell Disorders With Crisis, Unspecified
Keywords: Sickle Cell Anemia
Quality of Life
Antioxidant
Anti inflammatory
Sorghum bicolor
Lead sponsor: Lagos State University
Sponsor class: OTHER
First posted: 2012-10-11
Enrollment: 96
Sex: ALL
Minimum age (years): 14
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. AGE : 14 To 40 years
2. SEX: Both sexes
3. Homozygous for the S gene (SS)

Exclusion Criteria:

1. Age below 14 years and above 40 years
2. Evidence of organ failure i.e heart failure, renal failure
3. No consent for study
4. Poor adherence to treatment and irregular visit to the clinic
5. Presence of chronic inflammation
6. Pregnancy

Primary outcomes:
measure: number of severe bone pain crises and hospital admissions in one year
timeFrame: 12 months
Secondary outcomes:
measure: Antioxidant and anti-inflammatory effect
timeFrame: 12 months
Other outcomes:
Locations:
city: Ikeja
country: Nigeria
facility: Lagos State University Teaching Hospital
state: Lagos
Study officials:
affiliation: Lagos State University
name: A O Dosunmu, M.D.
role: PRINCIPAL_INVESTIGATOR
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