Evaluation of the Effectiveness of Ginkgo Biloba regimen on cognitive function in patients undergoing electroconvulsive therapy: Double blind clinical trial
Evaluation of the Effectiveness of Ginkgo Biloba regimen on cognitive function in patients undergoing electroconvulsive therapy: Double blind clinical trial
Design
The clinical trial has a control group, with parallel groups, double-blind, randomized, phase 3 on 80 patients with randomized Random block permutation method.
Settings and conduct
The present study was performed as a double-blind phase 3 clinical trial in the psychiatric ward of Ahvaz Golestan Hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All patients admitted to the psychiatric ward of َAhvaz Golestan Hospital aged 18 to 60 years whose illness has been confirmed by a psychiatrist
Exclusion criteria: History of epilepsy, History of coagulation disorders, History of alcohol and drug abuse, History of drug allergy, Patients who have received electroconvulsive therapy in the last 6 months before study
Intervention groups
Case group: Ginkgo biloba administrated 48 hours before shock therapy. The case group is given 6-12 bilateral or unilateral ECT sessions (3 times a week) and one Ginkgo biloba tablet (200 mg tablet) daily after meals until the end of ECT sessions.
Control Group: Placebo administrated 48 hours before shock therapy. The case group is given 6-12 bilateral or unilateral ECT sessions (3 times a week) and one Placebo capsule daily after meals until the end of ECT sessions.
Main outcome variables
Mini-Mental State Examination scale , Wechsler Memory Scale III scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200516047470N1
Registration date:2020-08-21, 1399/05/31
Registration timing:registered_while_recruiting
Last update:2020-08-21, 1399/05/31
Update count:0
Registration date
2020-08-21, 1399/05/31
Registrant information
Name
Elham Zeynali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3038
Email address
zeynali_e@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-08, 1399/01/20
Expected recruitment end date
2020-12-20, 1399/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Effectiveness of Ginkgo Biloba regimen on cognitive function in patients undergoing electroconvulsive therapy: Double blind clinical trial
Public title
Evaluation of the Effectiveness of Ginkgo Biloba regimen on cognitive function in patients undergoing electroconvulsive therapy: Double blind clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients admitted to the psychiatric ward of َAhvaz Golestan Hospital aged 18 to 60 years whose illness has been confirmed by a psychiatrist
Exclusion criteria:
History of epilepsy
History of coagulation disorders
History of alcohol and drug abuse
History of drug allergy
Patients who have received electroconvulsive therapy in the last 6 months before study
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Because we would like two study groups have the same sample size, we will use block randomization by Statistical Analysis System (SAS). Blocking is used to create the number of samples in the number of samples assigned to each of the studied groups. In this research, four random blocks are used. In a way that , after sampling, according to the order of eligible participants entrance to study, the designated group of the participant will become apparent, and just allocated person knows it and the researcher and sampler will never understand which sample will enter to the intervening group.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the researcher, clinical evaluator, analyst, and patient are unaware of which drug or placebo is in either group. Medications and placebos will be similar in shape, color, and taste.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapour University of Medical Sciences
Street address
Ahvaz Jundishapour University of Medical Sciences, Golestan blv, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2019-12-28, 1398/10/07
Ethics committee reference number
IR.AJUMS.REC.1398.700
Health conditions studied
1
Description of health condition studied
Psychosis
ICD-10 code
F15
ICD-10 code description
Other stimulant related disorders
Primary outcomes
1
Description
Mini-Mental State Examination
Timepoint
Before, during and after the intervention
Method of measurement
Mini-Mental State Examination Scale
2
Description
Memory
Timepoint
Before, during and after the intervention
Method of measurement
Wechsler Memory Scale III
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Ginkgo biloba administrated 48 hours before shock therapy. The case group given 6-12 bilateral or unilateral ECT sessions (3 times a week) and one Ginkgo biloba tablet (200 mg tablet) daily after meals until the end of ECT sessions.
Category
Treatment - Drugs
2
Description
Control group: Placebo administrated 48 hours before shock therapy. The control group given 6-12 bilateral or unilateral ECT sessions (3 times a week) and one Placebo tablet daily after meals until the end of ECT sessions.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Golestan Hospital
Full name of responsible person
Masumeh Nazarinasab
Street address
Jundishapour University of Medical Sciences, Golestan blv, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3587 4366
Email
Nazarinasab-m@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badavi
Street address
Ahvaz Jundishapour University of Medical Sciences, Golestan blv, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3587 4366
Email
src@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Elham Zeynali
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Boulevard, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3374 3038
Fax
Email
zeynali_e@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Elham Zeynali
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Boulevard, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3374 3038
Fax
Email
zeynali_e@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Elham Zeynali
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Boulevard, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3374 3038
Fax
Email
zeynali_e@ajums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
It depends on the university
When the data will become available and for how long
It depends on the university
To whom data/document is available
It depends on the university
Under which criteria data/document could be used
It depends on the university
From where data/document is obtainable
It depends on the university
What processes are involved for a request to access data/document