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

NCT01703104 | Completed Phase 1 DMC

• 1 other identifier: LASUTH/SCD02/2012
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Sickle Cell Anemia

Keywords

Sorghum bicolor; sickle cell anaemia; haematological parameters

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Adverse Events

  The number of participants who reported with Adverse events for the 12-week duration of the study

  12 weeks

Secondary Outcomes (1)

• number of blood transfusions during the 12-week trial period

  12 weeks

Study Arms (2)

Paludrine + Folic Acid

ACTIVE COMPARATOR

This arm uses routine drugs, Paludrine + Folic Acid

Drug: Paludrine + Folic Acid

Paludrine + Folic Acid + Jobelyn

ACTIVE COMPARATOR

This group uses Paludrine + Folic Acid + Jobelyn

Dietary Supplement: Paludrine + Folic Acid + Jobelyn

Interventions

Paludrine + Folic Acid DRUG

This is the combination of routine drugs for treating sickle cell disease

Also known as: Routine drugs

Paludrine + Folic Acid

Paludrine + Folic Acid + Jobelyn DIETARY_SUPPLEMENT

Combination of routine drugs + Jobelyn

Also known as: 1. Routine Drugs, i.e. Paludirine + Folic Acid, 2. Sorghum bicolor extract (Jobelyn)

Paludrine + Folic Acid + Jobelyn

Eligibility Criteria

• Age: 14 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lagos State University: lead

Study Sites (1)

Lagos State University Teaching Hospital

Ikeja, Lagos, 100001, Nigeria

Location

Related Publications (19)

• Brohan 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.

  PMID: 21381750 BACKGROUND

• 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.

  PMID: 22489620 BACKGROUND

• Kayode 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.

  PMID: 21322653 BACKGROUND

• 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.

  PMID: 19256554 BACKGROUND

• 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. doi: 10.1021/jf062516t.

  PMID: 17227050 BACKGROUND

• 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. doi: 10.1128/JVI.18.2.596-603.1976.

  PMID: 178900 BACKGROUND

• 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.

  PMID: 20673059 BACKGROUND

• 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.

  PMID: 22792362 BACKGROUND

• 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.

  PMID: 21780844 BACKGROUND

• Awika JM, McDonough CM, Rooney LW. Decorticating sorghum to concentrate healthy phytochemicals. J Agric Food Chem. 2005 Aug 10;53(16):6230-4. doi: 10.1021/jf0510384.

  PMID: 16076098 BACKGROUND

• 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. doi: 10.1016/s1569-1993(02)00079-6.

  PMID: 15463820 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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

  BACKGROUND

• 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. doi: 10.1016/j.jep.2007.01.013. Epub 2007 Jan 18.

  PMID: 17306481 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• Eniojukan JF, Bolajoko AA. Toxicological Profiles of Commercial Herbal Preperation, Jobelyn. International Journal of Health Research, 2(4), 369-374, 2009.

  BACKGROUND

• USDA Database for the Oxygen Radical Absorbance Capacity (ORAC) of Selected Foods, Release 2, U.S. Department of Agriculture, 2010.

  BACKGROUND

MeSH Terms

Conditions

Anemia, Sickle Cell

Interventions

Proguanil; Folic Acid

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• A O Dosunmu, M.D.

  Lagos State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: CONSULTANT IN THE DEPARTMENT OF HAEMATOLOGY & BLOOD TRANSFUSION, LASUTH

Study Record Dates

• First Submitted: October 3, 2012
• First Posted: October 10, 2012
• Study Start: January 1, 2012
• Primary Completion: March 1, 2012
• Study Completion: August 1, 2012
• Last Updated: October 10, 2012

Record last verified: 2012-10

Locations

NG (1)