The Safety and Effectiveness of Jobelyn in Pre-operative Management of Anaemia in Gynaecological Patients

• ClinicalTrials.gov Identifier: NCT01670955
• Recruitment Status: Completed
• First Posted: August 23, 2012
• Last Update Posted: May 18, 2016
• Sponsor: Lagos State University
• Collaborator: Health Forever Product Limited. Lagos, Nigeria
• Information provided by (Responsible Party): Dr. A. Tayo, Lagos State University

Tracking Information

• First Submitted Date: August 18, 2012
• First Posted Date: August 23, 2012
• Last Update Posted Date: May 18, 2016
• Study Start Date: December 2012
• Actual Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 22, 2012)

Anaemia [ Time Frame: 3 months ]

Change in haematological parameters

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 22, 2012)

morbidity [ Time Frame: 3 months ]

Reduced postoperative morbidity

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: August 22, 2012)

Hospital Stay [ Time Frame: 3 months ]

Duration of hospital stay

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: The Safety and Effectiveness of Jobelyn in Pre-operative Management of Anaemia in Gynaecological Patients
• Official Title: A Prospective Phase II/III Randomized, Blinded Study to Demonstrate the Safety and Effectiveness of Jobelyn ( a Herbal Preparation ) in Pre-operative Management of Anaemia in Gynaecological Patients
• Brief Summary: PROTOCOL FOR THE STUDY OF THE SAFETY AND EFFICACY OF JOBELYN, IN THE PREOPERATIVE MANAGEMENT OF ANAEMIA IN GYNAECOLOGICAL PATIENTS

Detailed Description

It has long been known that anaemia increases the risk of death and complications in patients who have cardiovascular surgery, but results of a recent study show that these risks are increased in patients with anaemia who undergo various types of surgery, including gynaecological procedures.

Compared with patients without anaemia, the risk of death within 30 days after surgery was 42% higher among patients with anaemia. In addition, patients with anemia were 35% more likely to experience cardiac, respiratory, urinary, and wound complications as well as sepsis and blood clots.

Because even mild anaemia increases the risk of postoperative morbidity in patients undergoing major non-cardiac surgery, doctors need to consider preoperative treatment of anaemia when possible. More research is needed to establish the efficacy, safety and cost-effectiveness of pre-operative anaemia management.

One of the major clinical issues in many gynaecological patients in Nigeria is that of optimizing the packed cell volume before surgery. Anaemia could be traced to multiple factors notable of which are high prevalence of infection, worm infestation and malnutrition (R). In other to reduce the waiting time and reduce morbidity and mortality associated with surgery, it is important to correct the packed cell volume adequately before surgery.

The traditional method of correcting PCV involves the use of 'routine' haematinics such as Ferrous sulphate, Folic acid and Multivitamin. This is in addition to dietary advice. While the efficacy of these drugs has been well acknowledged in clinical practice, there is dearth of literatures on their specific influence on haematological parameters. Majority of Nigerians are gradually having a change of perception about traditional medicines with gradual shift towards their use. It is believed that traditional drugs act faster and more effective than other orthodox drugs in conventional use. One of such area is in the correction of anaemia.

Sorghum bicolor, a grain long used in Africa for its high nutritional value also exhibits strong antioxidant properties and antiinflammatory effects. The traditional preparation of Sorghum bicolor has an oxygen radical absorbance capacity (ORAC) OF 37,622 micro mole TE/g. This is much higher than other botanical preparations. Complementing the antioxidant properties, Sorghum bicolor also exhibits anti inflammatory effects and demonstrated selective COX-2 inhibition, providing effective reduction in inflammation without residual side effects.

Sorghum bicolor extract has been shown to increase the haematocrit and haemoglobin level and reduce the white cell count in trypanosome brucei brucei induced anaemia in experimental rabbits. These effects were conclusive within 49 days of experimentation. Animals sacrificed after the administration of lethal dose Jobelyn were shown to have congestion of the liver, kidneys and lungs. This might be as a result of direct effect on these organs or a sign of cardiotoxicity. However there is a wide therapeutic range.

Sorghum bicolor is the proprietary name for the product intended to treat sickle cell disease. It is exactly the same as jobelyn which is currently marketed as a nutritional supplement. Jobelyn is marketed in 250mg capsules of sorghum bicolor leaf extract. The product is widely marketed in the United States and in Nigeria. Many pregnant women have been using it regularly for a long time without any report of adverse effect.

The sorghum bicolor extract is expected to increase the haematocrit of' pregnant women within a short time.

• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: Single (Participant); Primary Purpose: Treatment
• Condition: Anemia

Intervention

• Dietary Supplement: Jobelyn
  Jobelyn is a sorghum bicolor extract marketed as dietary supplement
  Other Name: Sorghum bicolor extract
• Drug: Ferrous Sulphate + Folic Acid
  Ferrous Sulphate 600mg, thrice daily + Folic Acid, 5mg daily
  Other Name: Iron Tablets

Study Arms

• Active Comparator: Jobelyn + Ferrous Sulphate + Folic Acid
  Caps Jobelyn 250mg, 12 hourly + Ferrous Sulphate 600mg thrice daily + Folic Acid 5mg daily
  Interventions:

  • Dietary Supplement: Jobelyn
  • Drug: Ferrous Sulphate + Folic Acid
• Active Comparator: Ferrous Sulphate + Folic Acid
  Ferrous Sulphate 600mg, thrice daily + Folic Acid, 5mg daily
  Intervention: Drug: Ferrous Sulphate + Folic Acid

Publications *

• 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.
• 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.
• 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.
• 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. doi: 10.1021/jf062516t.
• 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.
• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 17, 2016): 73
• Original Estimated Enrollment (submitted: August 22, 2012): 45
• Actual Study Completion Date: December 2013
• Actual Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Nigeria

Administrative Information

• NCT Number: NCT01670955
• Other Study ID Numbers: LASUTH/08/2012
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Dr. A. Tayo, Lagos State University
• Original Responsible Party: Same as current
• Current Study Sponsor: Lagos State University
• Original Study Sponsor: Same as current
• Collaborators: Health Forever Product Limited. Lagos, Nigeria

Investigators

• Principal Investigator: Adetokunbo O Tayo, M.D.; Lagos State University

• PRS Account: Lagos State University
• Verification Date: May 2016