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The Efficacy of Jobelyn (Sorghum Bicolor Extract)in the Treatment of Sickle Cell Anemia

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ClinicalTrials.gov Identifier: NCT01703104
Recruitment Status : Completed
First Posted : October 10, 2012
Last Update Posted : October 10, 2012
Information provided by (Responsible Party):
Dr. A. O. Dosunmu, Lagos State University

Brief Summary:
The primary objective is to determine if there is a significant increase in the haematocrit value of patients on Jobelyn and standard therapy compared to those on standard therapy alone.

Condition or disease Intervention/treatment Phase
Sickle Cell Anemia Drug: Paludrine + Folic Acid Dietary Supplement: Paludrine + Folic Acid + Jobelyn Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: The Effect of Jobelyn ( Extract of Sorghum Bicolor) on the Haematological Parameters of Patients With Sickle Cell Anaemia Disease.
Study Start Date : January 2012
Actual Primary Completion Date : March 2012
Actual Study Completion Date : August 2012

Arm Intervention/treatment
Active Comparator: Paludrine + Folic Acid
This arm uses routine drugs, Paludrine + Folic Acid
Drug: Paludrine + Folic Acid
This is the combination of routine drugs for treating sickle cell disease
Other Name: Routine drugs

Active Comparator: Paludrine + Folic Acid + Jobelyn
This group uses Paludrine + Folic Acid + Jobelyn
Dietary Supplement: Paludrine + Folic Acid + Jobelyn
Combination of routine drugs + Jobelyn
Other Names:
  • 1. Routine Drugs, i.e. Paludirine + Folic Acid
  • 2. Sorghum bicolor extract (Jobelyn)

Primary Outcome Measures :
  1. Number of Participants with Adverse Events [ Time Frame: 12 weeks ]
    The number of participants who reported with Adverse events for the 12-week duration of the study

Secondary Outcome Measures :
  1. number of blood transfusions during the 12-week trial period [ Time Frame: 12 weeks ]
    No of blood transfusions carried out during the period as a result of anaemia

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Ages Eligible for Study:   14 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female 14 to 45 years of age
  • Haemoglobin SS

Exclusion Criteria:

  • Patients with chronic inflammatory disease like tuberculosis
  • Patients with chronic viral hepatitis or positive for human immunodeficiency virus
  • Patients with autoimmune disorders.

    . patients with other haemoglobinopathy

  • Pregnancy or anticipated pregnancy.
  • Patient on drug abuse or alcohol abuse.
  • Patients on treatment for organ failure

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): NCT01703104

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Lagos State University Teaching Hospital
Ikeja, Lagos, Nigeria, 100001
Sponsors and Collaborators
Lagos State University
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Principal Investigator: A O Dosunmu, M.D. Lagos State University
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
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.

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ClinicalTrials.gov Identifier: NCT01703104    
Other Study ID Numbers: LASUTH/SCD02/2012
First Posted: October 10, 2012    Key Record Dates
Last Update Posted: October 10, 2012
Last Verified: October 2012
Keywords provided by Dr. A. O. Dosunmu, Lagos State University:
Sorghum bicolor
sickle cell anaemia
haematological parameters
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Hematologic Diseases
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Genetic Diseases, Inborn
Folic Acid
Vitamin B Complex
Physiological Effects of Drugs
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action