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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Lagos State University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Health Forever Product Limited. Lagos, Nigeria
Information provided by (Responsible Party):
Dr. A. Tayo, Lagos State University
ClinicalTrials.gov Identifier:
NCT01670955
First received: August 18, 2012
Last updated: September 1, 2012
Last verified: September 2012
  Purpose

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


Condition Intervention Phase
Anemia
Dietary Supplement: Jobelyn
Drug: Ferrous Sulphate + Folic Acid
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Lagos State University:

Primary Outcome Measures:
  • Anaemia [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Change in haematological parameters


Secondary Outcome Measures:
  • morbidity [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Reduced postoperative morbidity


Other Outcome Measures:
  • Hospital Stay [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Duration of hospital stay


Estimated Enrollment: 45
Study Start Date: September 2012
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Jobelyn + Ferrous Sulphate + Folic Acid
Caps Jobelyn 250mg, 12 hourly + Ferrous Sulphate 600mg thrice daily + Folic Acid 5mg daily
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
Active Comparator: Ferrous Sulphate + Folic Acid
Ferrous Sulphate 600mg, thrice daily + Folic Acid, 5mg daily
Drug: Ferrous Sulphate + Folic Acid
Ferrous Sulphate 600mg, thrice daily + Folic Acid, 5mg daily
Other Name: Iron Tablets

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01670955

Locations
Nigeria
Lagos State University Teaching Hospital Recruiting
Ikeja, Lagos, Nigeria, 100001
Contact: Adetokunbo O Tayo, M.D.    +2348033068656    tokunbunmi@yahoo.com   
Contact: Adedoyin O Dosunmu, M.D.    +2348039308432    doyin_dosunmu@yahoo.com   
Principal Investigator: Adetokunbo O Tayo, M.D.         
Sub-Investigator: Adedoyin O Dosunmu, M.D.         
Sub-Investigator: Olufemi Oloyede, M.D.         
Sub-Investigator: I. D. Akinola, M.D.         
Sub-Investigator: T. A. Ottun, M.D.         
Sub-Investigator: A. A. Adeowumi, M.D.         
Sponsors and Collaborators
Lagos State University
Health Forever Product Limited. Lagos, Nigeria
Investigators
Principal Investigator: Adetokunbo O Tayo, M.D. Lagos State University
  More Information

Publications:

Responsible Party: Dr. A. Tayo, CONSULTANT IN THE DEPARTMENT OF GYNAECOLOGY AND OBSTETRICS, LASUTH, Lagos State University
ClinicalTrials.gov Identifier: NCT01670955     History of Changes
Other Study ID Numbers: LASUTH/08/2012
Study First Received: August 18, 2012
Last Updated: September 1, 2012
Health Authority: Nigeria: The National Agency for Food and Drug Administration and Control

Keywords provided by Lagos State University:
Anemia
preoperative
gynecological patients
Sorghum bicolor
Packed Cells Volume

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Folic Acid
Vitamin B Complex
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014