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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. A. O. Dosunmu, Lagos State University
ClinicalTrials.gov Identifier:
NCT01703104
First received: October 3, 2012
Last updated: October 5, 2012
Last verified: October 2012
  Purpose

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 Intervention Phase
Sickle Cell Anemia
Drug: Paludrine + Folic Acid
Dietary Supplement: Paludrine + Folic Acid + Jobelyn
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
Official Title: The Effect of Jobelyn ( Extract of Sorghum Bicolor) on the Haematological Parameters of Patients With Sickle Cell Anaemia Disease.

Resource links provided by NLM:


Further study details as provided by Lagos State University:

Primary Outcome Measures:
  • Number of Participants with Adverse Events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    The number of participants who reported with Adverse events for the 12-week duration of the study


Secondary Outcome Measures:
  • number of blood transfusions during the 12-week trial period [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    No of blood transfusions carried out during the period as a result of anaemia


Enrollment: 150
Study Start Date: January 2012
Study Completion Date: August 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   14 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01703104

Locations
Nigeria
Lagos State University Teaching Hospital
Ikeja, Lagos, Nigeria, 100001
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: NCT01703104     History of Changes
Other Study ID Numbers: LASUTH/SCD02/2012
Study First Received: October 3, 2012
Last Updated: October 5, 2012
Health Authority: Nigeria: The National Agency for Food and Drug Administration and Control

Keywords provided by Lagos State University:
Sorghum bicolor
sickle cell anaemia
haematological parameters

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

ClinicalTrials.gov processed this record on October 19, 2014