The objective of this double blind clinical trial was to determine the effectiveness of Ginkgo biloba on positive and negative symptoms of schizophrenic patient treated with Rispridone. 60 patients with schizophrenia were admitted to Sina hospital of Joneghan were assigned to receive routine treatment and 4mg risperidone three times daily and placebo of Ginkgo biloba routine treatment plus 4mg Risperidone three times daily and Ginkgo biloba tablet in three doses of 80 mg daily (240 mg) for 12 weeks. Positive and negative symptoms of schizophrenia 2, 4, 6, 8, 12 weeks after starting intervention and one month after discontinuation of treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138903192085N3
Registration date:2010-06-09, 1389/03/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-06-09, 1389/03/19
Registrant information
Name
Neda Parvin
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 1333 5652
Email address
nedali285@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahrekord University of Medical Sciences
Expected recruitment start date
2009-12-22, 1388/10/01
Expected recruitment end date
2010-12-22, 1389/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Ginkgo biloba effects in the treatment of patients with chronic schizophrenia treated with Risperidone in Joneghan Sinai Hospital
Public title
Ginkgo biloba effects in the treatment of patients with chronic schizophrenia treated with Risperidone in Joneghan Sinai Hospital
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Schizophrenia diagnosis
Exclusion criteria: Use of other herbal medicines, aspirin or anticoagulant drugs, clotting problems before and during treatment with Ginkgo
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahrekord University of Medical Sciences
Street address
Shahrekord University of Medical Sciences, Rahmatie, Shahrekord
City
Shahrekord
Postal code
Approval date
2008-09-26, 1387/07/05
Ethics committee reference number
5-7-87
Health conditions studied
1
Description of health condition studied
Schizophrenia
ICD-10 code
F20, F29
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
Improve positive and negative signs
Timepoint
at the begining, 2, 4, 6, 8, 12 weeks after treatment and one month after end of treatment
Method of measurement
complete Anderson positive and negative questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Routine treatment plus 4mg risperidone three times daily and Ginkgo biloba tablet in three doses of 80 mg daily (240 mg) for 12 weeks.
Category
Treatment - Drugs
2
Description
Routine treatment and 4mg risperidone three times daily and placebo for 12 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital Jonghan
Full name of responsible person
Parvin N
Street address
City
Joneghan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Neda Parvin
Street address
Shahrekord University of Medical Sciences, Rahmatie, Shahrekord
City
Shahrekord
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahrekord University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahrekord University of Medical Sciences, Rahmatie, Shahrekord
Full name of responsible person
Neda Parvin
Position
Lecturer, Nursig and Midwifery department
Other areas of specialty/work
Street address
Rahmatie, Shahrekord, Iran
City
Shahrekord
Postal code
8814613785
Phone
+98 38 1333 5648
Fax
Email
np285@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Neda Parvin
Position
Lecturer, Nursing and Midwifery Department
Other areas of specialty/work
Street address
Shahrekord University of Medical Sciences, Rahmatie, Shahrekord
City
Shahrekord
Postal code
8814613785
Phone
+98 38 1333 5654
Fax
Email
np285@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)