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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Lagos State University
Sponsor:
Information provided by (Responsible Party):
Dr. A. O. Dosunmu, Lagos State University
ClinicalTrials.gov Identifier:
NCT01704794
First received: October 3, 2012
Last updated: April 1, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Antioxidant Effect of the Extract of Jobelyn (Sorghum Bicolor) on the Quality of Life of Patients With Sickle Cell Disease

Resource links provided by NLM:


Further study details as provided by Lagos State University:

Primary Outcome Measures:
  • number of severe bone pain crises and hospital admissions in one year [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Use of health related quality of life measures tool SF-36 and self reporting questionnaires


Secondary Outcome Measures:
  • Antioxidant and anti-inflammatory effect [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Increase in glutathion reductase, Increase in superoxide dismutase, Reduction in C reactive protein, Reduction in lactate dehydrogenase and Liver enzymes tests


Estimated Enrollment: 96
Study Start Date: April 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   14 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01704794

Contacts
Contact: A O Dosunmu, M.D. 2348023369785 doyin_dosunmu@yahoo.com

Locations
Nigeria
Lagos State University Teaching Hospital Recruiting
Ikeja, Lagos, Nigeria, 100001
Contact: A O Dosunmu, M.D.    2348023369785    doyin_dosunmu@yahoo.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.         
Sponsors and Collaborators
Lagos State University
Investigators
Principal Investigator: A O Dosunmu, M.D. Lagos State University
  More Information

Publications:
Erah P,O., Asonye C.C. Okhamafe A.O. 2003. Response of trypanosome brucei brucei induced anaemiato a commercialherbal preparation. African Journal of Biotechnology. 2,9, 307-311.
Nwinyi FC, Kwanashie HO. Evaluation of aqueous methanolic extract of Sorghum bicolor leaf base for antinociceptive and anti-inflammatory activities. African Journal of Biotechnology, 8 (18), 4642-4649, 2009.

Responsible Party: Dr. A. O. Dosunmu, CONSULTANT IN THE DEPARTMENT OF HAEMATOLOGY & BLOOD TRANSFUSION, LASUTH, Lagos State University
ClinicalTrials.gov Identifier: NCT01704794     History of Changes
Other Study ID Numbers: LASUTH/SCD01/2012
Study First Received: October 3, 2012
Last Updated: April 1, 2013
Health Authority: Nigeria: The National Agency for Food and Drug Administration and Control

Keywords provided by Lagos State University:
Sickle Cell Anemia
Quality of Life
Antioxidant
Anti inflammatory
Sorghum bicolor

Additional relevant MeSH terms:
Folic Acid
Vitamin B Complex
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Antioxidants
Proguanil
Hematinics
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Antimetabolites
Vitamins
Micronutrients
Growth Substances
Hematologic Agents

ClinicalTrials.gov processed this record on July 22, 2014