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

NCT02240173 | Unknown Phase 1

• 1 other identifier: MOjo
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia and Disorders With Psychotic Features

Keywords

antipsychotic Jobelyn schizophrenia sorghum bicolor

Outcome Measures

Primary Outcomes (1)

• The primary outcome will be the changes in psychotic symptoms

  This will be rated using the Brief Psychiatric Rating Scale (BPRS).

  8 Weeks

Secondary Outcomes (1)

• Patient's general health and social functioning

  8 Weeks

Other Outcomes (1)

• Side effects

  8 Weeks

Study Arms (2)

Jobelyn + Haloperidol

EXPERIMENTAL

Combination of the conventional drugs and Jobelyn

Dietary Supplement: Jobelyn

Haloperidol + Placebo

ACTIVE COMPARATOR

Combination of the conventional drug + Placebo

Drug: Haloperidol

Interventions

Jobelyn DIETARY_SUPPLEMENT

Jobelyn is a dietary supplement made from Sorghum bicolor

Also known as: Sorghum bicolor

Jobelyn + Haloperidol

Haloperidol DRUG

Conventional drug normally used for psychotic problems

Also known as: Haloperidol decanoate

Haloperidol + Placebo

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal Neuro-Psychiatric Hospital, Yaba: lead

Study Sites (1)

Federal Neuro-Psychiatric Hospital Yaba - Lagos

Lagos, Lagos, 101212, Nigeria

Location

Related Publications (11)

• 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.

  PMID: 24283768 BACKGROUND

• 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.

  PMID: 22489620 BACKGROUND

• 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.

  PMID: 23289787 BACKGROUND

• 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.

  PMID: 25337338 BACKGROUND

• 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.

  PMID: 25337327 BACKGROUND

• 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.

  PMID: 23412872 BACKGROUND

• 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.

  PMID: 23729562 BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 24799235 BACKGROUND

MeSH Terms

Conditions

Schizophrenia Spectrum and Other Psychotic Disorders

Interventions

Haloperidol; haloperidol decanoate

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Butyrophenones; Ketones; Organic Chemicals

Study Officials

• Moses Ojo, M.D.

  NPHY

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adefemi Adeoye, M.D.

CONTACT

+2348034752025; phemmy_aa@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2014
• First Posted: September 15, 2014
• Study Start: June 1, 2017
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: February 16, 2017

Record last verified: 2017-02

Locations

NG (1)