Evaluating the effect of black myrobalan fruit (Terminalia Chebula Retz.) on cognitive impairments, and positive and negative symptoms in patients with chronic schizophrenia
The aim of this study is to evaluate the effect of black myrobalan fruit (Terminalia Chebula Retz.) on cognitive impairments, and positive and negative symptoms in patients with chronic schizophrenia
Design
this study is a randomized, double-blind, controlled clinical trial with a parallel group design of 50 patients.
Settings and conduct
Patients are selected from Kerman Golestan Health Center. Participants and a physician are blinded with similar placebo and black myrobalan capsules,
Participants/Inclusion and exclusion criteria
The inclusion criteria are hospitalized patients with chronic schizophrenia based on DSM-IV criteria, and having no significant change in medication or symptoms over the previous 2 months
Exclusion criteria are mental retardation, substance dependence, and history of significant medical illness.
Intervention groups
Powdered black myrobalan fruit with almond oil (10% w/w) (in intervention
group) and starch as placebo (in control group) are administered
as three 500 mg capsule twice daily for four weeks.
Main outcome variables
Positive and negative symptoms and cognitive function are measured with Positive and Negative Syndrome Scale (PANSS) and Screen for Cognitive Impairment in Psychiatry (SCIP) questionnaires at baseline and after four weeks.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110310006026N7
Registration date:2018-04-07, 1397/01/18
Registration timing:prospective
Last update:2018-04-07, 1397/01/18
Update count:0
Registration date
2018-04-07, 1397/01/18
Registrant information
Name
Fatemeh Dabaghzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5034
Email address
dabaghzadeh@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-01, 1397/02/11
Expected recruitment end date
2019-05-01, 1398/02/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of black myrobalan fruit (Terminalia Chebula Retz.) on cognitive impairments, and positive and negative symptoms in patients with chronic schizophrenia
Public title
Evaluating the effect of black myrobalan fruit (Terminalia Chebula Retz.) on cognitive impairments, and positive and negative symptoms in patients with chronic schizophrenia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Hospitalized patients with chronic schizophrenia based on DSM-IV criteria
Having no significant change in medication or symptoms over the previous 2 months
Exclusion criteria:
Mental retardation
Substance dependence
History of significant medical illness
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants and physician: black myrobalan and placebo capsules had the same shape, color and outer packaging.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences
Street address
Beginning of Jahad Blvd., Tahmasebad Fourways
City
Kerman
Province
Kerman
Postal code
7619813159
Approval date
2018-03-17, 1396/12/26
Ethics committee reference number
IR.KMU.REC.1396.2491
Health conditions studied
1
Description of health condition studied
Chronic schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
Cognitive functions
Timepoint
At baseline and 4 weeks after intervention
Method of measurement
Screen for Cognitive Impairment in Psychiatry (SCIP) questionnaire
2
Description
Positive and negative symptoms
Timepoint
At baseline and 4 weeks after intervention
Method of measurement
Positive and Negative Syndrome Scale (PANSS) questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Powdered black myrobalan fruit with almond oil (10% w/w) are administered as three 500 mg capsule twice daily for four weeks.
Category
Treatment - Drugs
2
Description
Control group: starch as placebo (in control group) are administered as three 500 mg capsule twice daily for four weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Kerman Golestan Health Center
Full name of responsible person
Fatemeh Dabaghzadeh
Street address
Haft bagh high way
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5212
Email
fatemeh_dabaghzadeh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhtyi
Street address
Beginning of Jahad Blvd., Tahmasebad Fourways
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3815
Email
abpardakhty@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Fatemeh Dabaghzadeh
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Haft bagh high way
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5001
Email
fatemeh_dabaghzadeh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Fatemeh Dabaghzadeh
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Haft bagh high way
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5001
Email
fatemeh_dabaghzadeh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Kerman University of Medical Sciences
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Haft bagh high way
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5001
Email
fatemeh_dabaghzadeh@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available