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

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

Detailed Description
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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.

Official Title
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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

Conditions
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Anemia

Intervention / Treatment
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* Dietary Supplement: Jobelyn
* Drug: Ferrous Sulphate + Folic Acid


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Jobelyn + Ferrous Sulphate + Folic Acid<br>Caps Jobelyn 250mg, 12 hourly + Ferrous Sulphate 600mg thrice daily + Folic Acid 5mg daily | Dietary Supplement: Jobelyn<br>* Jobelyn is a sorghum bicolor extract marketed as dietary supplement<br>* Other names: Sorghum bicolor extract;Drug: Ferrous Sulphate + Folic Acid<br>* Ferrous Sulphate 600mg, thrice daily + Folic Acid, 5mg daily<br>* Other names: Iron Tablets;|
| Active Comparator: Ferrous Sulphate + Folic Acid<br>Ferrous Sulphate 600mg, thrice daily + Folic Acid, 5mg daily | Drug: Ferrous Sulphate + Folic Acid<br>* Ferrous Sulphate 600mg, thrice daily + Folic Acid, 5mg daily<br>* Other names: Iron Tablets;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anaemia | Change in haematological parameters | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| morbidity | Reduced postoperative morbidity | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anemia, preoperative, gynecological patients, Sorghum bicolor, Packed Cells Volume