Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
ClinicalTrials.gov |
Last refreshed on:
|
16 December 2017 |
Main ID: |
NCT02240173 |
Date of registration:
|
11/09/2014 |
Prospective Registration:
|
Yes |
Primary sponsor: |
|
Public title:
|
Antipsychotic Effects of Sorghum Bicolor (JOBELYN) in the Treatment of Schizophrenia
|
Scientific title:
|
Phase 2 Study of the Antipsychotic Effects of Sorghum Bicolor (JOBELYN) in the Treatment of Schizophrenia. |
Date of first enrolment:
|
June 2017 |
Target sample size:
|
100 |
Recruitment status: |
Not yet recruiting |
URL:
|
https://clinicaltrials.gov/show/NCT02240173 |
Study type:
|
Interventional |
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
|
Phase:
|
Phase 1/Phase 2
|
|
Countries of recruitment
|
Nigeria
| | | | | | | |
Contacts
|
Name:
|
Moses Ojo, M.D. |
Address:
|
|
Telephone:
|
|
Email:
|
|
Affiliation:
|
NPHY |
|
Name:
|
Adefemi Adeoye, M.D. |
Address:
|
|
Telephone:
|
+2348034752025 |
Email:
|
phemmy_aa@yahoo.com |
Affiliation:
|
|
| |
Key inclusion & exclusion 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
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
|
Health Condition(s) or Problem(s) studied
|
Schizophrenia and Disorders With Psychotic Features
|
Intervention(s)
|
Drug: Haloperidol
|
Dietary Supplement: Jobelyn
|
Primary Outcome(s)
|
The primary outcome will be the changes in psychotic symptoms
[Time Frame: 8 Weeks]
|
Secondary Outcome(s)
|
Patient's general health and social functioning
[Time Frame: 8 Weeks]
|
Source(s) of Monetary Support
|
Please refer to primary and secondary sponsors
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|