Effects of Ginkgo biloba in depression and cognitive problems of depressed patients treated with ECT referred to the psychiatric ward in Shahrekord Hajar hospital
This double blind clinical trial performed with aim of determination the effectiveness of the Ginkgo Biloba tablet in depression and cognitive problems of depressed patients treated with ECT referred to the psychiatric ward in Shahrekord Hajar hospital. Patients with major depression who had indication for ECT were randomly divided in two groups (30 persons control and 30 in case group). Control group treated with eight bilateral ECT, three times a week and three placebo tablet Ginkgo Biloba (every 8 hours) daily for 4 weeks. Case group treated with eighth session ECT 3 times a week and 40mg tablet Ginkgo Biloba every 8 hours after food for 4 weeks. The day before ECT, at the end of treatment period with ECT and 4 weeks after treatment, Cognition, memory and depression condition of patients assessed by Mini Mental State Exam and Hamilton depression questionnaire. Patients were evaluated for signs of bleeding and clotting problems during treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138903192085N2
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
Vice-chancellor for research, Shahrekord University of Medical Sciences
Expected recruitment start date
2009-10-23, 1388/08/01
Expected recruitment end date
2010-10-23, 1389/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Ginkgo biloba in depression and cognitive problems of depressed patients treated with ECT referred to the psychiatric ward in Shahrekord Hajar hospital
Public title
Effects of Ginkgo biloba in depression and cognitive problems of depressed patients treated with ECT referred to the psychiatric ward in Shahrekord Hajar hospital
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: suffering from the major depression, indication for treatment with ECT, scores more than 25 in Mini Mental State Exam
Exclusion criteria: Psychotic disorders such as schizophrenia, schizoaffective, delirium, dementia, amnesia, consumption of anticoagulant drugs, treatment with other medicinal plants, Pregnancy
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
2008-09-27, 1387/07/06
Ethics committee reference number
87-7-6
Health conditions studied
1
Description of health condition studied
depression
ICD-10 code
F32
ICD-10 code description
Depressive episode
Primary outcomes
1
Description
cognition and depression condition
Timepoint
before treatment, end of treatment, 4 weeks after begining the treatment
Method of measurement
Hamilton and Mini Mental State Exam questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Eight sessions of bilateral ECT, three times a week and placebo tablet for Ginkgo Biloba (every 8 hours) daily for 4 weeks
Category
Placebo
2
Description
Eight session of ECT 3 times a week and Ginkgo Bilob, 40mg tablets, every 8 hours after meal for 4 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hajar Hospital
Full name of responsible person
Parvin N
Street address
Nursing and Midwifery Department, Shahrekord University of Medical Sciences, Shahrekord
City
Shahrekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for research, Shahrekord University of Medical Sciences
Full name of responsible person
Neda Parvin
Street address
Nursindg and Midwifery Department, Shahrekord University of Medical Sciences, Rahmatie, Shahrekord,Iran
City
Shahrekord
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for research, 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
Full name of responsible person
Neda Parvin
Position
lecturer
Other areas of specialty/work
Street address
Nursing and Midwifery Department, Shahrekord University of Medical Sciences
City
Shahrekord
Postal code
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
Phone
+98 38 1333 5654
Fax
Email
np285@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)