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

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

Sponsors

Lead Sponsor: Lagos State University

Collaborator: Health Forever Product Limited. Lagos, Nigeria

Source Lagos State University
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.

Overall Status Completed
Start Date December 2012
Completion Date December 2013
Primary Completion Date June 2013
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Anaemia 3 months
Secondary Outcome
Measure Time Frame
morbidity 3 months
Enrollment 73
Condition
Intervention

Intervention Type: Dietary Supplement

Intervention Name: Jobelyn

Description: Jobelyn is a sorghum bicolor extract marketed as dietary supplement

Arm Group Label: Jobelyn + Ferrous Sulphate + Folic Acid

Other Name: Sorghum bicolor extract

Intervention Type: Drug

Intervention Name: Ferrous Sulphate + Folic Acid

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

Other Name: Iron Tablets

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

Gender: Female

Minimum Age: N/A

Maximum Age: N/A

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Adetokunbo O Tayo, M.D. Principal Investigator Lagos State University
Location
Facility: Lagos State University Teaching Hospital
Location Countries

Nigeria

Verification Date

May 2016

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Lagos State University

Investigator Full Name: Dr. A. Tayo

Investigator Title: CONSULTANT IN THE DEPARTMENT OF GYNAECOLOGY AND OBSTETRICS, LASUTH

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Jobelyn + Ferrous Sulphate + Folic Acid

Type: Active Comparator

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

Label: Ferrous Sulphate + Folic Acid

Type: Active Comparator

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

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: Single (Participant)

Source: ClinicalTrials.gov