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

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

Sponsors

Lead Sponsor: Lagos State University

Source 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.

Overall Status Unknown status
Start Date April 2013
Completion Date September 2014
Primary Completion Date April 2014
Phase Phase 1/Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
number of severe bone pain crises and hospital admissions in one year 12 months
Secondary Outcome
Measure Time Frame
Antioxidant and anti-inflammatory effect 12 months
Enrollment 96
Condition
Intervention

Intervention Type: Dietary Supplement

Intervention Name: Folic Acid + Paludrine + Jobelyn (500mg)

Description: Combination of routine drugs + Jobelyn

Arm Group Label: Folic Acid + Paludrine +Jobelyn (500mg)

Intervention Type: Drug

Intervention Name: Folic Acid + Paludrine + Jobelyn (250mg)

Description: Standard routine drugs for treatment of SCD with 250mg Jobelyn

Arm Group Label: Folic Acid + Paludrine +Jobelyn (250mg.)

Intervention Type: Dietary Supplement

Intervention Name: Folic Acid + Paludrine + Jobelyn (2mg)

Description: Combination of Paludrine + Folic Acid and Jobelyn 2mg (Sorghum bicolor extract)

Arm Group Label: Folic Acid + Paludrine + Jobelyn (2mg)

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

Gender: All

Minimum Age: 14 Years

Maximum Age: 40 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
A O Dosunmu, M.D. Principal Investigator Lagos State University
Overall Contact

Last Name: A O Dosunmu, M.D.

Phone: 2348023369785

Email: [email protected]

Location
Facility: Status: Contact: Investigator: Lagos State University Teaching Hospital A O Dosunmu, M.D. 2348023369785 [email protected] A O Dosunmu, M.D. Principal 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. Sub-Investigator
Location Countries

Nigeria

Verification Date

April 2013

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Lagos State University

Investigator Full Name: Dr. A. O. Dosunmu

Investigator Title: CONSULTANT IN THE DEPARTMENT OF HAEMATOLOGY & BLOOD TRANSFUSION, LASUTH

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: Folic Acid + Paludrine +Jobelyn (500mg)

Type: Active Comparator

Description: Folic acid 5mg given twice daily. Paludrine 50mg to 20mg daily. Jobelyn 500mg once daily.

Label: Folic Acid + Paludrine +Jobelyn (250mg.)

Type: Active Comparator

Description: Folic Acid 5mg daily Paludrine 20 - 40mg daily Jobelyn 250mg daily

Label: Folic Acid + Paludrine + Jobelyn (2mg)

Type: Active Comparator

Description: Folic Acid 5mg daily Paludrine 20 - 40mg daily Jobelyn 2mg daily

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Triple (Participant, Care Provider, Investigator)

Source: ClinicalTrials.gov