- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02240173
Antipsychotic Effects of Sorghum Bicolor (JOBELYN) in the Treatment of Schizophrenia
Phase 2 Study of the Antipsychotic Effects of Sorghum Bicolor (JOBELYN) in the Treatment of Schizophrenia.
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Lagos, Nigeria, 101212
- Federal Neuro-Psychiatric Hospital Yaba - Lagos
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Jobelyn + Haloperidol
Combination of the conventional drugs and Jobelyn
|
Jobelyn is a dietary supplement made from Sorghum bicolor
Other Names:
|
Active Comparator: Haloperidol + Placebo
Combination of the conventional drug + Placebo
|
Conventional drug normally used for psychotic problems
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
8 Weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient's general health and social functioning
Time Frame: 8 Weeks
|
To be assessed using the Clinical Global Impression Scale.
|
8 Weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Side effects
Time Frame: 8 Weeks
|
This will be measured using a side-effect scale designed for the study
|
8 Weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Moses Ojo, M.D., NPHY
Publications and helpful links
General Publications
- Geera B, Ojwang LO, Awika JM. New highly stable dimeric 3-deoxyanthocyanidin pigments from sorghum bicolor leaf sheath. J Food Sci. 2012 May;77(5):C566-72. doi: 10.1111/j.1750-3841.2012.02668.x. Epub 2012 Apr 10.
- Ayuba GI, Jensen GS, Benson KF, Okubena AM, Okubena O. Clinical efficacy of a West African sorghum bicolor-based traditional herbal preparation Jobelyn shows increased hemoglobin and CD4+ T-lymphocyte counts in HIV-positive patients. J Altern Complement Med. 2014 Jan;20(1):53-6. doi: 10.1089/acm.2013.0125. Epub 2013 Nov 27.
- Benson KF, Beaman JL, Ou B, Okubena A, Okubena O, Jensen GS. West African Sorghum bicolor leaf sheaths have anti-inflammatory and immune-modulating properties in vitro. J Med Food. 2013 Mar;16(3):230-8. doi: 10.1089/jmf.2012.0214. Epub 2013 Jan 5.
- Umukoro S, Omogbiya IA, Eduviere AT. Evaluation of the effect of jobelyn(®) on chemoconvulsants-induced seizure in mice. Basic Clin Neurosci. 2013 Spring;4(2):125-9.
- Umukoro S, Ugbomah A, Aderibigbe A, Omogbiya A. Antioxidant Property of Jobelyn as the Possible Mechanism Underlying its Anti-amnesic Activity in Rodents. Basic Clin Neurosci. 2013 Winter;4(1):42-9.
- Omogbiya IA, Umukoro S, Aderibigbe AO, Bakre AG. Jobelyn(R) pretreatment ameliorates symptoms of psychosis in experimental models. J Basic Clin Physiol Pharmacol. 2013;24(4):331-6. doi: 10.1515/jbcpp-2012-0073.
- Umukoro S, Omogbiya IA, Eduviere TA. Effect of Jobelyn(R) on intruder- and isolation-induced aggressive behavior in mice. J Basic Clin Physiol Pharmacol. 2013;24(4):263-9. doi: 10.1515/jbcpp-2012-0069.
- 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
- Yang L, Dykes L, Awika JM. Thermal stability of 3-deoxyanthocyanidin pigments. Food Chem. 2014 Oct 1;160:246-54. doi: 10.1016/j.foodchem.2014.03.105. Epub 2014 Apr 1.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Schizophrenia
- Schizophrenia Spectrum and Other Psychotic Disorders
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Antiemetics
- Gastrointestinal Agents
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Dopamine Agents
- Dopamine Antagonists
- Anti-Dyskinesia Agents
- Haloperidol
- Haloperidol decanoate
Other Study ID Numbers
- MOjo
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Schizophrenia and Disorders With Psychotic Features
-
MaineHealthColumbia University; University of California, Irvine; Harvard UniversityCompletedPsychotic Disorders | Prodromal Schizophrenia | Severe Major Depression With Psychotic Features | Severe Bipolar Disorder With Psychotic FeaturesUnited States
-
Instituto de Investigación Hospital Universitario...CompletedSchizophrenia and Disorders With Psychotic Feature | Psychotic EpisodeSpain
-
Instituto de Investigación Hospital Universitario...Carlos III Health Institute; European Regional Development FundCompletedSchizophrenia and Disorders With Psychotic Features | Psychotic EpisodeSpain
-
University of ManchesterKing's College London; Northern Care Alliance NHS Foundation Trust; University... and other collaboratorsCompletedSchizophrenia and Disorders With Psychotic Features
-
Indiana UniversityNational Institute of Mental Health (NIMH); Yale University; University of Michigan and other collaboratorsRecruitingSchizophrenia | Schizoaffective Disorder | Major Depression With Psychotic Features | Schizophreniform Disorders | Bipolar Disorder With Psychotic FeaturesUnited States
-
The Hong Kong Polytechnic UniversityUniversity of Turku; University of Helsinki; Kowloon Hospital, Hong Kong; Pamela... and other collaboratorsCompletedCognitive Function | Schizophrenia and Disorders With Psychotic FeaturesHong Kong
-
University of Sao PauloUnknownSchizophrenia and Disorders With Psychotic FeaturesBrazil
-
Yale UniversityCompletedSchizophrenia and Disorders With Psychotic FeaturesUnited States
-
Centre de Recherche de l'Institut Universitaire...UnknownDisorders | Schizophrenia and Disorders With Psychotic FeaturesCanada
-
University of ArizonaInstitute for Mental Health ResearchCompletedSchizophrenia | Schizoaffective Disorder | Major Depression With Psychotic Features | Bipolar Disorder With Psychotic Features | Psychotic Disorder Not Otherwise Specified (NOS) | Recent-Onset PsychosisUnited States
Clinical Trials on Jobelyn
-
Lagos State UniversityUnknownOther Sickle-cell Disorders With Crisis, UnspecifiedNigeria
-
Natural Immune Systems IncCompleted
-
Lagos State UniversityCompletedSickle Cell AnemiaNigeria
-
Lagos State UniversityHealth Forever Product Limited. Lagos, NigeriaCompleted
-
Lagos State UniversityUnknownHaematological AbnormalityNigeria