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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2013 by Dr. A. O. Dosunmu, Lagos State University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01704794
First Posted: October 11, 2012
Last Update Posted: April 4, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. A. O. Dosunmu, Lagos State University
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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 Dr. A. O. Dosunmu, Lagos State University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


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

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Bröhan M, Jerkovic V, Collin S. Potentiality of red sorghum for producing stilbenoid-enriched beers with high antioxidant activity. J Agric Food Chem. 2011 Apr 27;59(8):4088-94. doi: 10.1021/jf1047755. Epub 2011 Mar 7.
Geera B, Ojwang LO, Awika JM. New highly stable dimeric 3-deoxyanthocyanidin pigments from sorghum bicolor leaf sheath. J Food Sci. 2012 May;77(5):C566-72. doi: 10.1111/j.1750-3841.2012.02668.x. Epub 2012 Apr 10.
Kayodé AP, Nout MJ, Linnemann AR, Hounhouigan JD, Berghofer E, Siebenhandl-Ehn S. Uncommonly high levels of 3-deoxyanthocyanidins and antioxidant capacity in the leaf sheaths of dye sorghum. J Agric Food Chem. 2011 Feb 23;59(4):1178-84. doi: 10.1021/jf103963t. Epub 2011 Jan 25.
Yang L, Browning JD, Awika JM. Sorghum 3-deoxyanthocyanins possess strong phase II enzyme inducer activity and cancer cell growth inhibition properties. J Agric Food Chem. 2009 Mar 11;57(5):1797-804. doi: 10.1021/jf8035066.
Shih CH, Siu SO, Ng R, Wong E, Chiu LC, Chu IK, Lo C. Quantitative analysis of anticancer 3-deoxyanthocyanidins in infected sorghum seedlings. J Agric Food Chem. 2007 Jan 24;55(2):254-9.
Hunt DM, Emerson SU, Wagner RR. RNA- temperature-sensitive mutants of vesicular stomatitis virus: L-protein thermosensitivity accounts for transcriptase restriction of group I mutants. J Virol. 1976 May;18(2):596-603.
Burdette A, Garner PL, Mayer EP, Hargrove JL, Hartle DK, Greenspan P. Anti-inflammatory activity of select sorghum (Sorghum bicolor) brans. J Med Food. 2010 Aug;13(4):879-87. doi: 10.1089/jmf.2009.0147.
Park JH, Darvin P, Lim EJ, Joung YH, Hong DY, Park EU, Park SH, Choi SK, Moon ES, Cho BW, Park KD, Lee HK, Kim MJ, Park DS, Chung IM, Yang YM. Hwanggeumchal sorghum induces cell cycle arrest, and suppresses tumor growth and metastasis through Jak2/STAT pathways in breast cancer xenografts. PLoS One. 2012;7(7):e40531. doi: 10.1371/journal.pone.0040531. Epub 2012 Jul 6.
Wu L, Huang Z, Qin P, Yao Y, Meng X, Zou J, Zhu K, Ren G. Chemical characterization of a procyanidin-rich extract from sorghum bran and its effect on oxidative stress and tumor inhibition in vivo. J Agric Food Chem. 2011 Aug 24;59(16):8609-15. doi: 10.1021/jf2015528. Epub 2011 Jul 29.
Awika JM, McDonough CM, Rooney LW. Decorticating sorghum to concentrate healthy phytochemicals. J Agric Food Chem. 2005 Aug 10;53(16):6230-4.
Gee L, Abbott J, Conway SP, Etherington C, Webb AK. Validation of the SF-36 for the assessment of quality of life in adolescents and adults with cystic fibrosis. J Cyst Fibros. 2002 Sep;1(3):137-45.
Okochi,V.I.,Okpuzor J, Okubena M.O., Awoyemi A.K. 2003 . The Influence of African Herbal Formula on the haematological parameters of trypanosome infected rats. African Journal of Biotechnology. 2 (9), 312-316.
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.
Ogwumike OO. Hemopoietic effect of aqueous extract of the leaf sheath of Sorghum bicolor in albino rats. African Journal of Biomedical. Research. (2002): Vol 5; 69 - 71
Oladiji AT, Jacob TO, Yakubu MT. Anti-anaemic potentials of aqueous extract of Sorghum bicolor (L.) moench stem bark in rats. J Ethnopharmacol. 2007 May 22;111(3):651-6. Epub 2007 Jan 18.
Akande IS, Oseni AA, Biobaku OA. Effects of aqueous extract of Sorghum bicolor on hepatic, histological and haematological indices in rats. Journal of Cell and Animal Biology 4(9), 137-142, 2010.
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.
Eniojukan JF, Bolajoko AA. Toxicological Profiles of Commercial Herbal Preperation, Jobelyn. International Journal of Health Research, 2(4), 369-374, 2009.
USDA Database for the Oxygen Radical Absorbance Capacity (ORAC) of Selected Foods, Release 2, U.S. Department of Agriculture, 2010.

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
First Submitted: October 3, 2012
First Posted: October 11, 2012
Last Update Posted: April 4, 2013
Last Verified: April 2013

Keywords provided by Dr. A. O. Dosunmu, Lagos State University:
Sickle Cell Anemia
Quality of Life
Antioxidant
Anti inflammatory
Sorghum bicolor

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


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