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

Primary Purpose

Schizophrenia and Disorders With Psychotic Features

Status
Unknown status
Phase
Phase 1
Locations
Nigeria
Study Type
Interventional
Intervention
Jobelyn
Haloperidol
Sponsored by
Federal Neuro-Psychiatric Hospital, Yaba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia and Disorders With Psychotic Features focused on measuring antipsychotic Jobelyn schizophrenia sorghum bicolor

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Federal Neuro-Psychiatric Hospital Yaba - Lagos

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Jobelyn + Haloperidol

Haloperidol + Placebo

Arm Description

Combination of the conventional drugs and Jobelyn

Combination of the conventional drug + Placebo

Outcomes

Primary Outcome Measures

The primary outcome will be the changes in psychotic symptoms
This will be rated using the Brief Psychiatric Rating Scale (BPRS).

Secondary Outcome Measures

Patient's general health and social functioning
To be assessed using the Clinical Global Impression Scale.

Full Information

First Posted
September 11, 2014
Last Updated
February 14, 2017
Sponsor
Federal Neuro-Psychiatric Hospital, Yaba
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1. Study Identification

Unique Protocol Identification Number
NCT02240173
Brief Title
Antipsychotic Effects of Sorghum Bicolor (JOBELYN) in the Treatment of Schizophrenia
Official Title
Phase 2 Study of the Antipsychotic Effects of Sorghum Bicolor (JOBELYN) in the Treatment of Schizophrenia.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 2017 (Anticipated)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Federal Neuro-Psychiatric Hospital, Yaba

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia and Disorders With Psychotic Features
Keywords
antipsychotic Jobelyn schizophrenia sorghum bicolor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Jobelyn + Haloperidol
Arm Type
Experimental
Arm Description
Combination of the conventional drugs and Jobelyn
Arm Title
Haloperidol + Placebo
Arm Type
Active Comparator
Arm Description
Combination of the conventional drug + Placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Jobelyn
Other Intervention Name(s)
Sorghum bicolor
Intervention Description
Jobelyn is a dietary supplement made from Sorghum bicolor
Intervention Type
Drug
Intervention Name(s)
Haloperidol
Other Intervention Name(s)
Haloperidol decanoate
Intervention Description
Conventional drug normally used for psychotic problems
Primary Outcome Measure Information:
Title
The primary outcome will be the changes in psychotic symptoms
Description
This will be rated using the Brief Psychiatric Rating Scale (BPRS).
Time Frame
8 Weeks
Secondary Outcome Measure Information:
Title
Patient's general health and social functioning
Description
To be assessed using the Clinical Global Impression Scale.
Time Frame
8 Weeks
Other Pre-specified Outcome Measures:
Title
Side effects
Description
This will be measured using a side-effect scale designed for the study
Time Frame
8 Weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adefemi Adeoye, M.D.
Phone
+2348034752025
Email
phemmy_aa@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moses Ojo, M.D.
Organizational Affiliation
NPHY
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal Neuro-Psychiatric Hospital Yaba - Lagos
City
Lagos
ZIP/Postal Code
101212
Country
Nigeria
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adefemi A Adeoye, M.D.
First Name & Middle Initial & Last Name & Degree
I I Adeosun, M. D..
First Name & Middle Initial & Last Name & Degree
O S Oluwaniyi, M.D.
First Name & Middle Initial & Last Name & Degree
J A Kajero, M.D.
First Name & Middle Initial & Last Name & Degree
T O Oduguwa, M.D.
First Name & Middle Initial & Last Name & Degree
T A Adewumi, M.D.
First Name & Middle Initial & Last Name & Degree
A A Adegbohun, M.D.
First Name & Middle Initial & Last Name & Degree
O H Famurewa, M.D.

12. IPD Sharing Statement

Citations:
PubMed Identifier
24283768
Citation
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.
Results Reference
background
PubMed Identifier
22489620
Citation
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.
Results Reference
background
PubMed Identifier
23289787
Citation
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.
Results Reference
background
PubMed Identifier
25337338
Citation
Umukoro S, Omogbiya IA, Eduviere AT. Evaluation of the effect of jobelyn((R)) on chemoconvulsants-induced seizure in mice. Basic Clin Neurosci. 2013 Spring;4(2):125-9.
Results Reference
background
PubMed Identifier
25337327
Citation
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.
Results Reference
background
PubMed Identifier
23412872
Citation
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.
Results Reference
background
PubMed Identifier
23729562
Citation
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.
Results Reference
background
Citation
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
Results Reference
background
Citation
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
Results Reference
background
Citation
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
Results Reference
background
PubMed Identifier
24799235
Citation
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.
Results Reference
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Antipsychotic Effects of Sorghum Bicolor (JOBELYN) in the Treatment of Schizophrenia

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