<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02240173</url>
  </required_header>
  <id_info>
    <org_study_id>MOjo</org_study_id>
    <nct_id>NCT02240173</nct_id>
  </id_info>
  <brief_title>Antipsychotic Effects of Sorghum Bicolor (JOBELYN) in the Treatment of Schizophrenia</brief_title>
  <official_title>Phase 2 Study of the Antipsychotic Effects of Sorghum Bicolor (JOBELYN) in the Treatment of Schizophrenia.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal Neuro-Psychiatric Hospital, Yaba</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Federal Neuro-Psychiatric Hospital, Yaba</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Sorghum bicolor is a naturally growing plant which has been of health benefit to the people&#xD;
      of West Africa who traditionally prepare its leaf for various nutritional and health&#xD;
      reasons.The food and nutritional fact analysis showed that Jobelyn is rich in Carbohydrates,&#xD;
      Protein, Dietary Fiber, Iron, Natural Vitamins like B12 and Vitamin C. It also contains&#xD;
      Selenium, Omega 3,6 and 9 and other essential elements and fatty acids. Although the&#xD;
      determinants of mental health are complex, the emerging and compelling evidence for nutrition&#xD;
      as a crucial factor in the high prevalence and incidence of mental disorders suggests that&#xD;
      diet is as important to psychiatry as it is to cardiology, endocrinology, and&#xD;
      gastroenterology. Evidence is steadily growing for the relation between dietary quality (and&#xD;
      potential nutritional deficiencies) and mental health, and for the select use of&#xD;
      nutrient-based supplements to address deficiencies, or as monotherapies or augmentation&#xD;
      therapies. There is currently strong advocacy for the recognition of diet and nutrition as&#xD;
      central determinants of both physical and mental health.Its anti-inflammatory and haematocrit&#xD;
      boosting properties have been well documented though the precise mechanism of action is still&#xD;
      largely unknown. Its use has recently been extended to the field of mental health where&#xD;
      findings in animal study suggest it could be of help in relieve of psychosis. The need for&#xD;
      this study is therefore aimed at investigating the effect of this drug in patients with&#xD;
      schizophrenia which is the prototypical psychotic disorder.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Schizophrenia is a major psychiatric disorder with a chronic and debilitating course. It is&#xD;
      the archetypal psychotic disorder with a prevalence of about 1% worldwide. The treatment of&#xD;
      this psychotic disorder has evolved over the years after the discovery of Chlorpromazine.&#xD;
      Despite the availability of several treatment options in practice, research into the&#xD;
      possibility of creating a drug breakthrough continues.&#xD;
&#xD;
      Sorghum bicolor, a naturally growing plant rich in several phytochemical including&#xD;
      proanthocyanidins, anthocyanidins, apigenin, proapigeninidin, apigeninidin, luteolin,&#xD;
      naringenins, flavonoids, and polyphenols (Omogbiya et al 2012) and prepared as a capsule&#xD;
      called Jobelyn. This plant has been found to be of health benefit to the people of West&#xD;
      Africa who traditionally prepare its leaf for various nutritional and health reasons. The&#xD;
      anti-inflammatory and haematocrit boosting properties have been well documented and utilized&#xD;
      though the precise mechanism of action is still not entirely known (Benson et al. 2013). Its&#xD;
      usefulness in neuropsychiatric conditions has recently been explored albeit through animal&#xD;
      studies.&#xD;
&#xD;
      In animals, Jobelyn has been suggested to have anti-amnestic property which has been&#xD;
      suggested to be related to its antioxidant activity (Umukoro et al. 2013a). Other studies&#xD;
      also suggested that Jobelyn has an anti-aggressive effect (Umukoro et al. 2012) and&#xD;
      antidepressant like property probably related to its stimulation of serotonergic pathways&#xD;
      (Umukoro et al. 2013b). Jobelyn has also been suggested to exhibit anti-psychotic-like&#xD;
      activity with the benefit of lacking extra-pyramidal side effect risks and therefore being&#xD;
      postulated to be of possible benefit in the symptomatic relief of psychosis (Omogbiya et al.&#xD;
      2012).&#xD;
&#xD;
      There is however limited information in terms of the suggested neuropsychiatric conditions&#xD;
      especially in humans despite the recognized safety profile consequent upon its use as&#xD;
      haematocrit boosting agent. This study therefore aims at exploring the usefulness of Jobelyn&#xD;
      in the treatment of patients with Schizophrenia as an adjunct to standard treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">June 2017</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">December 2017</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The primary outcome will be the changes in psychotic symptoms</measure>
    <time_frame>8 Weeks</time_frame>
    <description>This will be rated using the Brief Psychiatric Rating Scale (BPRS).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient's general health and social functioning</measure>
    <time_frame>8 Weeks</time_frame>
    <description>To be assessed using the Clinical Global Impression Scale.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Side effects</measure>
    <time_frame>8 Weeks</time_frame>
    <description>This will be measured using a side-effect scale designed for the study</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Schizophrenia and Disorders With Psychotic Features</condition>
  <arm_group>
    <arm_group_label>Jobelyn + Haloperidol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Combination of the conventional drugs and Jobelyn</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Haloperidol + Placebo</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Combination of the conventional drug + Placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Jobelyn</intervention_name>
    <description>Jobelyn is a dietary supplement made from Sorghum bicolor</description>
    <arm_group_label>Jobelyn + Haloperidol</arm_group_label>
    <other_name>Sorghum bicolor</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Haloperidol</intervention_name>
    <description>Conventional drug normally used for psychotic problems</description>
    <arm_group_label>Haloperidol + Placebo</arm_group_label>
    <other_name>Haloperidol decanoate</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Participants will be adults with current diagnosis of schizophrenia (meeting the ICD-10&#xD;
        criteria).&#xD;
&#xD;
          -  Adults who are above 18 years of age and gave informed consent&#xD;
&#xD;
          -  Currently meet the ICD-10 diagnosis of Schizophrenia and confirmed with MINI- PLUS&#xD;
&#xD;
          -  Antipsychotic naive before recruitment into study or defaulted from treatment for at&#xD;
             least 6 months 'prior to contact with study&#xD;
&#xD;
          -  Not on Jobelyn or Megafit currently or in the past 6months prior to contact with study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Having another current ICD-l0 diagnosis or a seizure disorder&#xD;
&#xD;
          -  Serious or chronic physical illness&#xD;
&#xD;
          -  Known severe drug allergies or hypersensitivity to Jobelyn, Megafit or Haloperidol&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Moses Ojo, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>NPHY</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Adefemi Adeoye, M.D.</last_name>
    <phone>+2348034752025</phone>
    <email>phemmy_aa@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Federal Neuro-Psychiatric Hospital Yaba - Lagos</name>
      <address>
        <city>Lagos</city>
        <zip>101212</zip>
        <country>Nigeria</country>
      </address>
    </facility>
    <investigator>
      <last_name>Adefemi A Adeoye, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>I I Adeosun, M. D..</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>O S Oluwaniyi, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>J A Kajero, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>T O Oduguwa, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>T A Adewumi, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>A A Adegbohun, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>O H Famurewa, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Nigeria</country>
  </location_countries>
  <reference>
    <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.</citation>
    <PMID>24283768</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>22489620</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>23289787</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>25337338</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>25337327</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>23412872</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>23729562</PMID>
  </reference>
  <reference>
    <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</citation>
  </reference>
  <reference>
    <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</citation>
  </reference>
  <reference>
    <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</citation>
  </reference>
  <reference>
    <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.</citation>
    <PMID>24799235</PMID>
  </reference>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>September 11, 2014</study_first_submitted>
  <study_first_submitted_qc>September 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 15, 2014</study_first_posted>
  <last_update_submitted>February 14, 2017</last_update_submitted>
  <last_update_submitted_qc>February 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">February 16, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>antipsychotic Jobelyn schizophrenia sorghum bicolor</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Schizophrenia</mesh_term>
    <mesh_term>Schizophrenia Spectrum and Other Psychotic Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Haloperidol</mesh_term>
    <mesh_term>Haloperidol decanoate</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02240173
org study id: MOjo
nct id: NCT02240173
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: The primary outcome will be the changes in psychotic symptoms
time frame: 8 Weeks
description: This will be rated using the Brief Psychiatric Rating Scale (BPRS).
measure: Patient's general health and social functioning
time frame: 8 Weeks
description: To be assessed using the Clinical Global Impression Scale.
measure: Side effects
time frame: 8 Weeks
description: This will be measured using a side-effect scale designed for the study
arm group label: Jobelyn + Haloperidol
arm group type: Experimental
description: Combination of the conventional drugs and Jobelyn
arm group label: Haloperidol + Placebo
arm group type: Active Comparator
description: Combination of the conventional drug + Placebo
intervention type: Dietary Supplement
intervention name: Jobelyn
description: Jobelyn is a dietary supplement made from Sorghum bicolor
arm group label: Jobelyn + Haloperidol
other name: Sorghum bicolor
intervention type: Drug
intervention name: Haloperidol
description: Conventional drug normally used for psychotic problems
arm group label: Haloperidol + Placebo
other name: Haloperidol decanoate
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Moses Ojo, M.D.
role: Principal Investigator
affiliation: NPHY
last name: Adefemi Adeoye, M.D.
phone: +2348034752025
email: phemmy_aa@yahoo.com
facility: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Nigeria
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.
PMID: 24283768
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.
PMID: 22489620
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.
PMID: 23289787
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.
PMID: 25337338
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.
PMID: 25337327
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.
PMID: 23412872
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.
PMID: 23729562
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
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
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
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.
PMID: 24799235
responsible party type: Sponsor
mesh term: Schizophrenia
mesh term: Schizophrenia Spectrum and Other Psychotic Disorders
mesh term: Haloperidol
mesh term: Haloperidol decanoate