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

Primary Purpose

Other Sickle-cell Disorders With Crisis, Unspecified

Status
Unknown status
Phase
Phase 1
Locations
Nigeria
Study Type
Interventional
Intervention
Folic Acid + Paludrine + Jobelyn (500mg)
Folic Acid + Paludrine + Jobelyn (250mg)
Folic Acid + Paludrine + Jobelyn (2mg)
Sponsored by
Lagos State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Other Sickle-cell Disorders With Crisis, Unspecified focused on measuring Sickle Cell Anemia, Quality of Life, Antioxidant, Anti inflammatory, Sorghum bicolor

Eligibility Criteria

14 Years - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Lagos State University Teaching HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Folic Acid + Paludrine +Jobelyn (500mg)

Folic Acid + Paludrine +Jobelyn (250mg.)

Folic Acid + Paludrine + Jobelyn (2mg)

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

number of severe bone pain crises and hospital admissions in one year
Use of health related quality of life measures tool SF-36 and self reporting questionnaires

Secondary Outcome Measures

Antioxidant and anti-inflammatory effect
Increase in glutathion reductase, Increase in superoxide dismutase, Reduction in C reactive protein, Reduction in lactate dehydrogenase and Liver enzymes tests

Full Information

First Posted
October 3, 2012
Last Updated
April 1, 2013
Sponsor
Lagos State University
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1. Study Identification

Unique Protocol Identification Number
NCT01704794
Brief Title
Quality of Life Study for Sickle Cell Patients Treated With Jobelyn (Sorghum Bicolor Extract)
Official Title
Antioxidant Effect of the Extract of Jobelyn (Sorghum Bicolor) on the Quality of Life of Patients With Sickle Cell Disease
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Unknown status
Study Start Date
April 2013 (undefined)
Primary Completion Date
April 2014 (Anticipated)
Study Completion Date
September 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lagos State University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Other Sickle-cell Disorders With Crisis, Unspecified
Keywords
Sickle Cell Anemia, Quality of Life, Antioxidant, Anti inflammatory, Sorghum bicolor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Folic Acid + Paludrine +Jobelyn (500mg)
Arm Type
Active Comparator
Arm Description
Folic acid 5mg given twice daily. Paludrine 50mg to 20mg daily. Jobelyn 500mg once daily.
Arm Title
Folic Acid + Paludrine +Jobelyn (250mg.)
Arm Type
Active Comparator
Arm Description
Folic Acid 5mg daily Paludrine 20 - 40mg daily Jobelyn 250mg daily
Arm Title
Folic Acid + Paludrine + Jobelyn (2mg)
Arm Type
Active Comparator
Arm Description
Folic Acid 5mg daily Paludrine 20 - 40mg daily Jobelyn 2mg daily
Intervention Type
Dietary Supplement
Intervention Name(s)
Folic Acid + Paludrine + Jobelyn (500mg)
Other Intervention Name(s)
Routine drugs, Sorghum bicolor extract (Jobelyn 500mg)
Intervention Description
Combination of routine drugs + Jobelyn
Intervention Type
Drug
Intervention Name(s)
Folic Acid + Paludrine + Jobelyn (250mg)
Other Intervention Name(s)
Routine drugs, Sorghum bicolor extract (250mg)
Intervention Description
Standard routine drugs for treatment of SCD with 250mg Jobelyn
Intervention Type
Dietary Supplement
Intervention Name(s)
Folic Acid + Paludrine + Jobelyn (2mg)
Other Intervention Name(s)
Other Names: Routine drugs, Jobelyn (Sorghum bicolor extract)
Intervention Description
Combination of Paludrine + Folic Acid and Jobelyn 2mg (Sorghum bicolor extract)
Primary Outcome Measure Information:
Title
number of severe bone pain crises and hospital admissions in one year
Description
Use of health related quality of life measures tool SF-36 and self reporting questionnaires
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Antioxidant and anti-inflammatory effect
Description
Increase in glutathion reductase, Increase in superoxide dismutase, Reduction in C reactive protein, Reduction in lactate dehydrogenase and Liver enzymes tests
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: AGE : 14 To 40 years SEX: Both sexes Homozygous for the S gene (SS) Exclusion Criteria: Age below 14 years and above 40 years Evidence of organ failure i.e heart failure, renal failure No consent for study Poor adherence to treatment and irregular visit to the clinic Presence of chronic inflammation Pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
A O Dosunmu, M.D.
Phone
2348023369785
Email
doyin_dosunmu@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
A O Dosunmu, M.D.
Organizational Affiliation
Lagos State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lagos State University Teaching Hospital
City
Ikeja
State/Province
Lagos
ZIP/Postal Code
100001
Country
Nigeria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
A O Dosunmu, M.D.
Phone
2348023369785
Email
doyin_dosunmu@yahoo.com
First Name & Middle Initial & Last Name & Degree
A O Dosunmu, M.D.
First Name & Middle Initial & Last Name & Degree
O O Odusanya, M.D.
First Name & Middle Initial & Last Name & Degree
I N AKinwunmi, M.D.
First Name & Middle Initial & Last Name & Degree
A A Akinbami, M.D.
First Name & Middle Initial & Last Name & Degree
M O Dada, M.D.
First Name & Middle Initial & Last Name & Degree
T M Balogun, M.D.
First Name & Middle Initial & Last Name & Degree
C K Yemitan, M.D.
First Name & Middle Initial & Last Name & Degree
J A Onakoya, M.D.
First Name & Middle Initial & Last Name & Degree
U O Oyekan, M.D.

12. IPD Sharing Statement

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

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