Antipsychotic Effects of Sorghum Bicolor (JOBELYN) in the Treatment of Schizophrenia
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|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
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|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia and Disorders With Psychotic Features||Dietary Supplement: Jobelyn Drug: Haloperidol||Phase 1 Phase 2|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
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
Conventional drug normally used for psychotic problems
Other Name: Haloperidol decanoate
- 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).
- Patient's general health and social functioning [ Time Frame: 8 Weeks ]To be assessed using the Clinical Global Impression Scale.
- Side effects [ Time Frame: 8 Weeks ]This will be measured using a side-effect scale designed for the study
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.
|Ages Eligible for Study:||Child, Adult, Older Adult|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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
- 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
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
|Contact: Adefemi Adeoye, M.D.||+email@example.com|
|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.|
|Principal Investigator:||Moses Ojo, M.D.||NPHY|
|Responsible Party:||Federal Neuro-Psychiatric Hospital, Yaba|
|Other Study ID Numbers:||
|First Posted:||September 15, 2014 Key Record Dates|
|Last Update Posted:||February 16, 2017|
|Last Verified:||February 2017|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
antipsychotic Jobelyn schizophrenia sorghum bicolor
Schizophrenia Spectrum and Other Psychotic Disorders
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Molecular Mechanisms of Pharmacological Action