Quality of Life Study for Sickle Cell Patients Treated With Jobelyn (Sorghum Bicolor Extract)
|ClinicalTrials.gov Identifier: NCT01704794|
Recruitment Status : Unknown
Verified April 2013 by Dr. A. O. Dosunmu, Lagos State University.
Recruitment status was: Recruiting
First Posted : October 11, 2012
Last Update Posted : April 4, 2013
|Condition or disease||Intervention/treatment||Phase|
|Other Sickle-cell Disorders With Crisis, Unspecified||Dietary Supplement: Folic Acid + Paludrine + Jobelyn (500mg) Drug: Folic Acid + Paludrine + Jobelyn (250mg) Dietary Supplement: Folic Acid + Paludrine + Jobelyn (2mg)||Phase 1 Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||96 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Antioxidant Effect of the Extract of Jobelyn (Sorghum Bicolor) on the Quality of Life of Patients With Sickle Cell Disease|
|Study Start Date :||April 2013|
|Estimated Primary Completion Date :||April 2014|
|Estimated Study Completion Date :||September 2014|
U.S. FDA Resources
Active Comparator: Folic Acid + Paludrine +Jobelyn (500mg)
Folic acid 5mg given twice daily. Paludrine 50mg to 20mg daily. Jobelyn 500mg once daily.
Dietary Supplement: Folic Acid + Paludrine + Jobelyn (500mg)
Combination of routine drugs + Jobelyn
Active Comparator: Folic Acid + Paludrine +Jobelyn (250mg.)
Folic Acid 5mg daily Paludrine 20 - 40mg daily Jobelyn 250mg daily
Drug: Folic Acid + Paludrine + Jobelyn (250mg)
Standard routine drugs for treatment of SCD with 250mg Jobelyn
Active Comparator: Folic Acid + Paludrine + Jobelyn (2mg)
Folic Acid 5mg daily Paludrine 20 - 40mg daily Jobelyn 2mg daily
Dietary Supplement: Folic Acid + Paludrine + Jobelyn (2mg)
Combination of Paludrine + Folic Acid and Jobelyn 2mg (Sorghum bicolor extract)
- number of severe bone pain crises and hospital admissions in one year [ Time Frame: 12 months ]Use of health related quality of life measures tool SF-36 and self reporting questionnaires
- Antioxidant and anti-inflammatory effect [ Time Frame: 12 months ]Increase in glutathion reductase, Increase in superoxide dismutase, Reduction in C reactive protein, Reduction in lactate dehydrogenase and Liver enzymes tests
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01704794
|Contact: A O Dosunmu, M.D.||firstname.lastname@example.org|
|Lagos State University Teaching Hospital||Recruiting|
|Ikeja, Lagos, Nigeria, 100001|
|Contact: A O Dosunmu, M.D. 2348023369785 email@example.com|
|Principal Investigator: A O Dosunmu, M.D.|
|Sub-Investigator: O O Odusanya, M.D.|
|Sub-Investigator: I N AKinwunmi, M.D.|
|Sub-Investigator: A A Akinbami, M.D.|
|Sub-Investigator: M O Dada, M.D.|
|Sub-Investigator: T M Balogun, M.D.|
|Sub-Investigator: C K Yemitan, M.D.|
|Sub-Investigator: J A Onakoya, M.D.|
|Sub-Investigator: U O Oyekan, M.D.|
|Principal Investigator:||A O Dosunmu, M.D.||Lagos State University|