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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02240173
Recruitment Status : Unknown
Verified February 2017 by Federal Neuro-Psychiatric Hospital, Yaba.
Recruitment status was:  Not yet recruiting
First Posted : September 15, 2014
Last Update Posted : February 16, 2017
Sponsor:
Information provided by (Responsible Party):
Federal Neuro-Psychiatric Hospital, Yaba

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Schizophrenia and Disorders With Psychotic Features Dietary Supplement: Jobelyn Drug: Haloperidol Phase 1 Phase 2

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Phase 2 Study of the Antipsychotic Effects of Sorghum Bicolor (JOBELYN) in the Treatment of Schizophrenia.
Estimated Study Start Date : June 2017
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Jobelyn + Haloperidol
Combination of the conventional drugs and Jobelyn
 Dietary Supplement: Jobelyn
Jobelyn is a dietary supplement made from Sorghum bicolor
Other Name: Sorghum bicolor
Active Comparator: Haloperidol + Placebo
Combination of the conventional drug + Placebo
 Drug: Haloperidol
Conventional drug normally used for psychotic problems
Other Name: Haloperidol decanoate


Outcome Measures
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Primary Outcome Measures :
  1. The primary outcome will be the changes in psychotic symptoms [ Time Frame: 8 Weeks ]
    This will be rated using the Brief Psychiatric Rating Scale (BPRS).


Secondary Outcome Measures :
  1. Patient's general health and social functioning [ Time Frame: 8 Weeks ]
    To be assessed using the Clinical Global Impression Scale.


Other Outcome Measures:
  1. Side effects [ Time Frame: 8 Weeks ]
    This will be measured using a side-effect scale designed for the study


Eligibility Criteria
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Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02240173


Contacts
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Contact: Adefemi Adeoye, M.D. +2348034752025 phemmy_aa@yahoo.com

Locations
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Nigeria
Federal Neuro-Psychiatric Hospital Yaba - Lagos
Lagos, Nigeria, 101212
Sub-Investigator: Adefemi A Adeoye, M.D.         
Sub-Investigator: I I Adeosun, M. D..         
Sub-Investigator: O S Oluwaniyi, M.D.         
Sub-Investigator: J A Kajero, M.D.         
Sub-Investigator: T O Oduguwa, M.D.         
Sub-Investigator: T A Adewumi, M.D.         
Sub-Investigator: A A Adegbohun, M.D.         
Sub-Investigator: O H Famurewa, M.D.         
Sponsors and Collaborators
Federal Neuro-Psychiatric Hospital, Yaba
Investigators
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Principal Investigator: Moses Ojo, M.D. NPHY
More Information
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Publications:
Toxicological Profiles of Commercial Herbal Preparation, Jobelyn® nternational Journal of Health Research, December 2009; 2(4): 369-374 © Poracom Academic Publishers. All rights reserved. Available at http://www.ijhr.org
The influence of African Herbal Formula on the haematological parameters of trypanosome infected rats VI Okochi, J Okpuzor, MO Okubena, AK Awoyemi African Journal of Biotechnology Vol.2(9) 2003: 312-316
Response of Trypanosoma brucei brucei-induced anaemia to a commercial herbal preparation ........... 4 African Journal of Biotechnology Vol. 2 (9), pp. 307-311, September 2003

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Responsible Party: Federal Neuro-Psychiatric Hospital, Yaba
ClinicalTrials.gov Identifier: NCT02240173    
Other Study ID Numbers: MOjo
First Posted: September 15, 2014    Key Record Dates
Last Update Posted: February 16, 2017
Last Verified: February 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Federal Neuro-Psychiatric Hospital, Yaba:
antipsychotic Jobelyn schizophrenia sorghum bicolor
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Haloperidol
Haloperidol decanoate
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
 Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents