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

April 1, 2013 updated by: Dr. A. O. Dosunmu, Lagos State University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

96

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Nigeria
    • Lagos
      • Ikeja, Lagos, Nigeria, 100001
        • Recruiting
        • Lagos State University Teaching Hospital
        • Contact:
        • 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.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Other Names:
  • Routine drugs
  • Sorghum bicolor extract (Jobelyn 500mg)
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
Other Names:
  • Routine drugs
  • Sorghum bicolor extract (250mg)
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)
Other Names:
  • Other Names: Routine drugs
  • Jobelyn (Sorghum bicolor extract)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lagos State University

Investigators

  • Principal Investigator: A O Dosunmu, M.D., Lagos State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Anticipated)

April 1, 2014

Study Completion (Anticipated)

September 1, 2014

Study Registration Dates

First Submitted

October 3, 2012

First Submitted That Met QC Criteria

October 10, 2012

First Posted (Estimate)

October 11, 2012

Study Record Updates

Last Update Posted (Estimate)

April 4, 2013

Last Update Submitted That Met QC Criteria

April 1, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LASUTH/SCD01/2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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