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

Phase 1

• Conditions: Other Sickle-cell Disorders With Crisis, Unspecified
• Interventions: Dietary Supplement: Folic Acid + Paludrine + Jobelyn (500mg); Drug: Folic Acid + Paludrine + Jobelyn (250mg); Dietary Supplement: Folic Acid + Paludrine + Jobelyn (2mg)

• Registration Number: NCT01704794
• Lead Sponsor: Lagos State University

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.

Study Timeline

• Study First Submitted: 2012-10-03
• Study First Submitted QC: 2012-10-10
• Study First Posted: 2012-10-11
• Status Verified: 2013-04
• Study Start: 2013-04
• Last Update Submitted: 2013-04-01
• Last Update Posted: 2013-04-04
• Primary Completion: 2014-04
• Study Completion: 2014-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 96

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Folic Acid + Paludrine +Jobelyn (500mg)	Folic Acid + Paludrine + Jobelyn (500mg)	Folic acid 5mg given twice daily. Paludrine 50mg to 20mg daily. Jobelyn 500mg once daily.
Folic Acid + Paludrine +Jobelyn (250mg.)	Folic Acid + Paludrine + Jobelyn (250mg)	Folic Acid 5mg daily Paludrine 20 - 40mg daily Jobelyn 250mg daily
Folic Acid + Paludrine + Jobelyn (2mg)	Folic Acid + Paludrine + Jobelyn (2mg)	Folic Acid 5mg daily Paludrine 20 - 40mg daily Jobelyn 2mg daily

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Antioxidant and anti-inflammatory effect	12 months	Increase in glutathion reductase, Increase in superoxide dismutase, Reduction in C reactive protein, Reduction in lactate dehydrogenase and Liver enzymes tests

Trial Locations

Locations (1)

Lagos State University Teaching Hospital; 🇳🇬 Ikeja, Lagos, Nigeria