Antipsychotic Effects of Sorghum Bicolor (JOBELYN) in the Treatment of Schizophrenia

Study Overview
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Brief Summary
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Sorghum bicolor is a naturally growing plant which has been of health benefit to the people of West Africa who traditionally prepare its leaf for various nutritional and health reasons.The food and nutritional fact analysis showed that Jobelyn is rich in Carbohydrates, Protein, Dietary Fiber, Iron, Natural Vitamins like B12 and Vitamin C. It also contains Selenium, Omega 3,6 and 9 and other essential elements and fatty acids. Although the determinants of mental health are complex, the emerging and compelling evidence for nutrition as a crucial factor in the high prevalence and incidence of mental disorders suggests that diet is as important to psychiatry as it is to cardiology, endocrinology, and gastroenterology. Evidence is steadily growing for the relation between dietary quality (and potential nutritional deficiencies) and mental health, and for the select use of nutrient-based supplements to address deficiencies, or as monotherapies or augmentation therapies. There is currently strong advocacy for the recognition of diet and nutrition as central determinants of both physical and mental health.Its anti-inflammatory and haematocrit boosting properties have been well documented though the precise mechanism of action is still largely unknown. Its use has recently been extended to the field of mental health where findings in animal study suggest it could be of help in relieve of psychosis. The need for this study is therefore aimed at investigating the effect of this drug in patients with schizophrenia which is the prototypical psychotic disorder.

Detailed Description
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Schizophrenia is a major psychiatric disorder with a chronic and debilitating course. It is the archetypal psychotic disorder with a prevalence of about 1% worldwide. The treatment of this psychotic disorder has evolved over the years after the discovery of Chlorpromazine. Despite the availability of several treatment options in practice, research into the possibility of creating a drug breakthrough continues. Sorghum bicolor, a naturally growing plant rich in several phytochemical including proanthocyanidins, anthocyanidins, apigenin, proapigeninidin, apigeninidin, luteolin, naringenins, flavonoids, and polyphenols (Omogbiya et al 2012) and prepared as a capsule called Jobelyn. This plant has been found to be of health benefit to the people of West Africa who traditionally prepare its leaf for various nutritional and health reasons. The anti-inflammatory and haematocrit boosting properties have been well documented and utilized though the precise mechanism of action is still not entirely known (Benson et al. 2013). Its usefulness in neuropsychiatric conditions has recently been explored albeit through animal studies. In animals, Jobelyn has been suggested to have anti-amnestic property which has been suggested to be related to its antioxidant activity (Umukoro et al. 2013a). Other studies also suggested that Jobelyn has an anti-aggressive effect (Umukoro et al. 2012) and antidepressant like property probably related to its stimulation of serotonergic pathways (Umukoro et al. 2013b). Jobelyn has also been suggested to exhibit anti-psychotic-like activity with the benefit of lacking extra-pyramidal side effect risks and therefore being postulated to be of possible benefit in the symptomatic relief of psychosis (Omogbiya et al. 2012). There is however limited information in terms of the suggested neuropsychiatric conditions especially in humans despite the recognized safety profile consequent upon its use as haematocrit boosting agent. This study therefore aims at exploring the usefulness of Jobelyn in the treatment of patients with Schizophrenia as an adjunct to standard treatment.

Official Title
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Phase 2 Study of the Antipsychotic Effects of Sorghum Bicolor (JOBELYN) in the Treatment of Schizophrenia.

Conditions
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Schizophrenia and Disorders With Psychotic Features

Intervention / Treatment
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* Dietary Supplement: Jobelyn
* Drug: Haloperidol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants will be adults with current diagnosis of schizophrenia (meeting the ICD-10 criteria). Adults who are above 18 years of age and gave informed consent Currently meet the ICD-10 diagnosis of Schizophrenia and confirmed with MINI- PLUS Antipsychotic naive before recruitment into study or defaulted from treatment for at least 6 months 'prior to contact with study Not on Jobelyn or Megafit currently or in the past 6months prior to contact with study Exclusion Criteria: Having another current ICD-l0 diagnosis or a seizure disorder Serious or chronic physical illness Known severe drug allergies or hypersensitivity to Jobelyn, Megafit or Haloperidol
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Jobelyn + Haloperidol<br>Combination of the conventional drugs and Jobelyn | Dietary Supplement: Jobelyn<br>* Jobelyn is a dietary supplement made from Sorghum bicolor<br>* Other names: Sorghum bicolor;|
| Active Comparator: Haloperidol + Placebo<br>Combination of the conventional drug + Placebo | Drug: Haloperidol<br>* Conventional drug normally used for psychotic problems<br>* Other names: Haloperidol decanoate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome will be the changes in psychotic symptoms | This will be rated using the Brief Psychiatric Rating Scale (BPRS). | 8 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient's general health and social functioning | To be assessed using the Clinical Global Impression Scale. | 8 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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antipsychotic Jobelyn schizophrenia sorghum bicolor