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

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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
Sponsor:
Information provided by (Responsible Party):
Dr. A. O. Dosunmu, Lagos State University

Tracking Information
First Submitted Date  ICMJE October 3, 2012
First Posted Date  ICMJE October 11, 2012
Last Update Posted Date April 4, 2013
Study Start Date  ICMJE April 2013
Estimated Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 10, 2012)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 10, 2012)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Quality of Life Study for Sickle Cell Patients Treated With Jobelyn (Sorghum Bicolor Extract)
Official Title  ICMJE Antioxidant Effect of the Extract of Jobelyn (Sorghum Bicolor) on the Quality of Life of Patients With Sickle Cell Disease
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Other Sickle-cell Disorders With Crisis, Unspecified
Intervention  ICMJE
  • Dietary Supplement: Folic Acid + Paludrine + Jobelyn (500mg)
    Combination of routine drugs + Jobelyn
    Other Names:
    • Routine drugs
    • Sorghum bicolor extract (Jobelyn 500mg)
  • Drug: Folic Acid + Paludrine + Jobelyn (250mg)
    Standard routine drugs for treatment of SCD with 250mg Jobelyn
    Other Names:
    • Routine drugs
    • Sorghum bicolor extract (250mg)
  • 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)
Study Arms  ICMJE
  • Active Comparator: Folic Acid + Paludrine +Jobelyn (500mg)
    Folic acid 5mg given twice daily. Paludrine 50mg to 20mg daily. Jobelyn 500mg once daily.
    Intervention: Dietary Supplement: Folic Acid + Paludrine + Jobelyn (500mg)
  • Active Comparator: Folic Acid + Paludrine +Jobelyn (250mg.)
    Folic Acid 5mg daily Paludrine 20 - 40mg daily Jobelyn 250mg daily
    Intervention: Drug: Folic Acid + Paludrine + Jobelyn (250mg)
  • Active Comparator: Folic Acid + Paludrine + Jobelyn (2mg)
    Folic Acid 5mg daily Paludrine 20 - 40mg daily Jobelyn 2mg daily
    Intervention: Dietary Supplement: Folic Acid + Paludrine + Jobelyn (2mg)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 10, 2012)
96
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2014
Estimated Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years to 40 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Nigeria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01704794
Other Study ID Numbers  ICMJE LASUTH/SCD01/2012
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. A. O. Dosunmu, Lagos State University
Study Sponsor  ICMJE Lagos State University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: A O Dosunmu, M.D. Lagos State University
PRS Account Lagos State University
Verification Date April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP