NCT01670955

Brief Summary

PROTOCOL FOR THE STUDY OF THE SAFETY AND EFFICACY OF JOBELYN, IN THE PREOPERATIVE MANAGEMENT OF ANAEMIA IN GYNAECOLOGICAL PATIENTS

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 23, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

May 18, 2016

Status Verified

May 1, 2016

Enrollment Period

6 months

First QC Date

August 18, 2012

Last Update Submit

May 17, 2016

Conditions

Anemia

Keywords

Anemiapreoperativegynecological patientsSorghum bicolorPacked Cells Volume

Outcome Measures

Primary Outcomes (1)

  • Anaemia

    Change in haematological parameters

    3 months

Secondary Outcomes (1)

  • morbidity

    3 months

Other Outcomes (1)

  • Hospital Stay

    3 months

Study Arms (2)

Jobelyn + Ferrous Sulphate + Folic Acid

ACTIVE COMPARATOR

Caps Jobelyn 250mg, 12 hourly + Ferrous Sulphate 600mg thrice daily + Folic Acid 5mg daily

Dietary Supplement: JobelynDrug: Ferrous Sulphate + Folic Acid

Ferrous Sulphate + Folic Acid

ACTIVE COMPARATOR

Ferrous Sulphate 600mg, thrice daily + Folic Acid, 5mg daily

Drug: Ferrous Sulphate + Folic Acid

Interventions

JobelynDIETARY_SUPPLEMENT

Jobelyn is a sorghum bicolor extract marketed as dietary supplement

Also known as: Sorghum bicolor extract
Jobelyn + Ferrous Sulphate + Folic Acid
Ferrous Sulphate + Folic AcidDRUG

Ferrous Sulphate 600mg, thrice daily + Folic Acid, 5mg daily

Also known as: Iron Tablets
Ferrous Sulphate + Folic AcidJobelyn + Ferrous Sulphate + Folic Acid

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Mild to moderate anaemia
  • Asymptomatic severe anaemia
  • Non life threatening gynaecological condition

You may not qualify if:

  • Failure to give informed consent
  • Symptomatic severe anaemia
  • Pregnancy
  • Malignancies and Chronic inflammatory disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lagos State University Teaching Hospital

Ikeja, Lagos, 100001, Nigeria

Location

Related Publications (11)

  • 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: 21381750BACKGROUND

  • 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: 22489620BACKGROUND

  • 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: 21322653BACKGROUND

  • 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: 19256554BACKGROUND

  • 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: 17227050BACKGROUND

  • Camargo Filho I, Cortez DA, Ueda-Nakamura T, Nakamura CV, Dias Filho BP. Antiviral activity and mode of action of a peptide isolated from Sorghum bicolor. Phytomedicine. 2008 Mar;15(3):202-8. doi: 10.1016/j.phymed.2007.07.059. Epub 2007 Sep 24.

    PMID: 17890069BACKGROUND

  • 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: 20673059BACKGROUND

  • 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: 22792362BACKGROUND

  • 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: 21780844BACKGROUND

  • Devi PS, Kumar MS, Das SM. Evaluation of antiproliferative activity of red sorghum bran anthocyanin on a human breast cancer cell line (mcf-7). Int J Breast Cancer. 2011;2011:891481. doi: 10.4061/2011/891481. Epub 2011 Oct 16.

    PMID: 22312562BACKGROUND

  • 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: 16076098BACKGROUND

MeSH Terms

Conditions

Anemia

Interventions

ferrous sulfateFolic AcidIron

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

PterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsMetals, HeavyElementsInorganic ChemicalsTransition ElementsMetals

Study Officials

  • Adetokunbo O Tayo, M.D.

    Lagos State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
CONSULTANT IN THE DEPARTMENT OF GYNAECOLOGY AND OBSTETRICS, LASUTH

Study Record Dates

First Submitted

August 18, 2012

First Posted

August 23, 2012

Study Start

December 1, 2012

Primary Completion

June 1, 2013

Study Completion

December 1, 2013

Last Updated

May 18, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations

NG(1)