Quality of Life Study for Sickle Cell Patients Treated With Jobelyn (Sorghum Bicolor Extract)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Antioxidant Effect of the Extract of Jobelyn (Sorghum Bicolor) on the Quality of Life of Patients With Sickle Cell Disease

Conditions
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Other Sickle-cell Disorders With Crisis, Unspecified

Intervention / Treatment
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* Dietary Supplement: Folic Acid + Paludrine + Jobelyn (500mg)
* Drug: Folic Acid + Paludrine + Jobelyn (250mg)
* Dietary Supplement: Folic Acid + Paludrine + Jobelyn (2mg)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: AGE : 14 To 40 years SEX: Both sexes Homozygous for the S gene (SS) Exclusion Criteria: Age below 14 years and above 40 years Evidence of organ failure i.e heart failure, renal failure No consent for study Poor adherence to treatment and irregular visit to the clinic Presence of chronic inflammation Pregnancy

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Folic Acid + Paludrine +Jobelyn (500mg)<br>Folic acid 5mg given twice daily. Paludrine 50mg to 20mg daily. Jobelyn 500mg once daily. | Dietary Supplement: Folic Acid + Paludrine + Jobelyn (500mg)<br>* Combination of routine drugs + Jobelyn<br>* Other names: Sorghum bicolor extract (Jobelyn 500mg);|
| Active Comparator: Folic Acid + Paludrine +Jobelyn (250mg.)<br>Folic Acid 5mg daily Paludrine 20 - 40mg daily Jobelyn 250mg daily | Drug: Folic Acid + Paludrine + Jobelyn (250mg)<br>* Standard routine drugs for treatment of SCD with 250mg Jobelyn<br>* Other names: Sorghum bicolor extract (250mg);|
| Active Comparator: Folic Acid + Paludrine + Jobelyn (2mg)<br>Folic Acid 5mg daily Paludrine 20 - 40mg daily Jobelyn 2mg daily | Dietary Supplement: Folic Acid + Paludrine + Jobelyn (2mg)<br>* Combination of Paludrine + Folic Acid and Jobelyn 2mg (Sorghum bicolor extract)<br>* Other names: Jobelyn (Sorghum bicolor extract);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of severe bone pain crises and hospital admissions in one year | Use of health related quality of life measures tool SF-36 and self reporting questionnaires | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antioxidant and anti-inflammatory effect | Increase in glutathion reductase, Increase in superoxide dismutase, Reduction in C reactive protein, Reduction in lactate dehydrogenase and Liver enzymes tests | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sickle Cell Anemia, Quality of Life, Antioxidant, Anti inflammatory, Sorghum bicolor