We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01670955
Recruitment Status : Completed
First Posted : August 23, 2012
Last Update Posted : May 18, 2016
Health Forever Product Limited. Lagos, Nigeria
Information provided by (Responsible Party):
Dr. A. Tayo, Lagos State University

Tracking Information
First Submitted Date  ICMJE August 18, 2012
First Posted Date  ICMJE August 23, 2012
Last Update Posted Date May 18, 2016
Study Start Date  ICMJE December 2012
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 22, 2012)
Anaemia [ Time Frame: 3 months ]
Change in haematological parameters
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 22, 2012)
morbidity [ Time Frame: 3 months ]
Reduced postoperative morbidity
Original Secondary Outcome Measures  ICMJE 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  ICMJE The Safety and Effectiveness of Jobelyn in Pre-operative Management of Anaemia in Gynaecological Patients
Official Title  ICMJE 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
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Anemia
Intervention  ICMJE
  • 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  ICMJE
  • Active Comparator: Jobelyn + Ferrous Sulphate + Folic Acid
    Caps Jobelyn 250mg, 12 hourly + Ferrous Sulphate 600mg thrice daily + Folic Acid 5mg daily
    • 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 *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 17, 2016)
Original Estimated Enrollment  ICMJE
 (submitted: August 22, 2012)
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Nigeria
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01670955
Other Study ID Numbers  ICMJE LASUTH/08/2012
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Dr. A. Tayo, Lagos State University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Lagos State University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Health Forever Product Limited. Lagos, Nigeria
Investigators  ICMJE
Principal Investigator: Adetokunbo O Tayo, M.D. Lagos State University
PRS Account Lagos State University
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP