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Quality of Life Study for Sickle Cell Patients Treated With Jobelyn (Sorghum Bicolor Extract)

Watumiaji waliosajiliwa tu ndio wanaweza kutafsiri nakala
Ingia / Ingia
Kiungo kimehifadhiwa kwenye clipboard
Hali
Wadhamini
Lagos State University

Maneno muhimu

Kikemikali

The purpose of this study is to determine the antioxidant effect of prolonged use of sorghum bicolor (jobelyn) to increase the level of plasma superoxide dismutase and glutathione reductase in patients with sickle cell disease and to determine if there is any improvement in the quality of life of the patients.

Maelezo

Jobelyn is an extract of sorghum bicolor that is popular in Nigeria as a herbal food supplement. This extract has been shown to have a high oxygen radical absorbance capacity (ORAC 37,622micro mole TE/g) compared to other botanical preparations 1. A second proven property is its anti inflammatory effect with a selective COX 2 inhibition 2. It has also been shown to correct anaemia induced in experimental rabbit by trypanosome brucei brucei 3.

Jobelyn is being consumed as a herbal nutritional supplement in many disorders including sickle cell disease in Nigeria without complaint in over 15 years. The toxicology profile is impressive with a wide therapeutic range.

Nigeria is one of the countries with the largest burden of sickle cell disease. It is a chronic genetic disorder that accounts for absenteeism at school and at work place. There is also a significant shortening of the life span of the affected patients. Sickle cell anaemia presents with recurrent bone pains and progressive organ damage that affects negatively the quality of life of the patients. Available measures that have been in use include use of hydroxyurea, chronic and acute red cell transfusion and haematopoietic stem cell transplantation. These have limitations in terms of adverse effects, cost and availability.

The pathogenesis involves intracellular precipitation of the mutant haemoglobin, rigidity of the cell, adhesion of cells to the endothelium. These cause recurrent tissue hypoxia and reperfusion which cause release of reactive oxygen series and agents of inflammation. The extract of sorghum is therefore expected to improve the quality of life of these patients.

Previous work done, have not investigated the long time effect of the extract on the quality of life of sickle cell patients. This study is therefore designed to compare the quality of life of patients on 500mg daily, 250mg daily and 2mg daily of jobelyn using adjusted standard tools. The secondary outcomes to study are changes in indicators of inflammation and systemic antioxidants in these patients. The study period is 12 months so that the period shall involve all the weather conditions in the region.

Tarehe

Imethibitishwa Mwisho: 03/31/2013
Iliyowasilishwa Kwanza: 10/02/2012
Uandikishaji uliokadiriwa Uliwasilishwa: 10/09/2012
Iliyotumwa Kwanza: 10/10/2012
Sasisho la Mwisho Liliwasilishwa: 03/31/2013
Sasisho la Mwisho Lilichapishwa: 04/03/2013
Tarehe halisi ya kuanza kwa masomo: 03/31/2013
Tarehe ya Kukamilisha Msingi iliyokadiriwa: 03/31/2014
Tarehe ya Kukamilisha Utafiti: 08/31/2014

Hali au ugonjwa

Other Sickle-cell Disorders With Crisis, Unspecified

Uingiliaji / matibabu

Dietary Supplement: Folic Acid + Paludrine +Jobelyn (500mg)

Drug: Folic Acid + Paludrine +Jobelyn (250mg.)

Dietary Supplement: Folic Acid + Paludrine + Jobelyn (2mg)

Awamu

Awamu 1/Awamu 2

Vikundi vya Arm

MkonoUingiliaji / matibabu
Active Comparator: Folic Acid + Paludrine +Jobelyn (500mg)
Folic acid 5mg given twice daily. Paludrine 50mg to 20mg daily. Jobelyn 500mg once daily.
Dietary Supplement: Folic Acid + Paludrine +Jobelyn (500mg)
Combination of routine drugs + Jobelyn
Active Comparator: Folic Acid + Paludrine +Jobelyn (250mg.)
Folic Acid 5mg daily Paludrine 20 - 40mg daily Jobelyn 250mg daily
Drug: Folic Acid + Paludrine +Jobelyn (250mg.)
Standard routine drugs for treatment of SCD with 250mg Jobelyn
Active Comparator: Folic Acid + Paludrine + Jobelyn (2mg)
Folic Acid 5mg daily Paludrine 20 - 40mg daily Jobelyn 2mg daily
Dietary Supplement: Folic Acid + Paludrine + Jobelyn (2mg)
Combination of Paludrine + Folic Acid and Jobelyn 2mg (Sorghum bicolor extract)

Vigezo vya Kustahiki

Zama zinazostahiki Kujifunza 14 Years Kwa 14 Years
Jinsia Inastahiki KujifunzaAll
Hupokea Wajitolea wa AfyaNdio
Vigezo

Inclusion Criteria:

1. AGE : 14 To 40 years

2. SEX: Both sexes

3. Homozygous for the S gene (SS)

Exclusion Criteria:

1. Age below 14 years and above 40 years

2. Evidence of organ failure i.e heart failure, renal failure

3. No consent for study

4. Poor adherence to treatment and irregular visit to the clinic

5. Presence of chronic inflammation

6. Pregnancy

Matokeo

Hatua za Matokeo ya Msingi

1. number of severe bone pain crises and hospital admissions in one year [12 months]

Use of health related quality of life measures tool SF-36 and self reporting questionnaires

Hatua za Matokeo ya Sekondari

1. Antioxidant and anti-inflammatory effect [12 months]

Increase in glutathion reductase, Increase in superoxide dismutase, Reduction in C reactive protein, Reduction in lactate dehydrogenase and Liver enzymes tests

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