Evaluating the effect of Ginkgo biloba extract on increasing healthy volunteers' memory, based on the evidences confirming or refutable.
Design
60 selected volunteers are divided into two groups: 30 volunteers are in the treatment group and 30 volunteers are in the control group. The drug packages marked and randomized are distributed among volunteers. It is a double-blind study.
Settings and conduct
This research is conducted among the students admitted at Shahid Beheshti University of Medical Sciences in 2016 and 2017 and studing in its faculty of pharmacy now. In this double-blind, placebo-controlled study, half of the volunteers are placed to the control group and the other half to the treatment group at random. Both volunteers and memory tester are unaware that each candidate is in the control group or treatment group. Packages containing placebo are encrypted with the letter A and Packages containing the drug are encrypted with the letter B.
Participants/Inclusion and exclusion criteria
Entry Criteria: All volunteers must have been taking the same course at the same university, aged between 19-20 years.
Lack of entry criteria: No candidate should be suffering from considerable depression or stress.
Intervention groups
In the treatment group, volunteers are given 120 mg of Ginkgo Biloba extract daily for 6 weeks, and in the control group, volunteers are given placebo daily for 6 weeks.
Main outcome variables
This study could report whether or not the extract of this plant has any effect on memory. Volunteer use of the plant extract or placebo may have side effects.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200218046537N1
Registration date:2020-04-20, 1399/02/01
Registration timing:prospective
Last update:2020-04-20, 1399/02/01
Update count:0
Registration date
2020-04-20, 1399/02/01
Registrant information
Name
Mohammad Amin Attar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3338 1583
Email address
maattar1993@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-03, 1399/02/14
Expected recruitment end date
2020-06-19, 1399/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the effect of Ginkgo Biloba tablet on improving memory in healthy valunteers
Public title
The effect of Ginkgo Biloba on memory enhancement
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
All healthy volunteers are 19-20 years old
Exclusion criteria:
Having severe anxiety
Having severe depression
Age
From 20 years old to 21 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this method, a mixture of drug and placebo packages are placed in a box and when offering them to the volunteers a package is selected randomly, without looking into the box. Then, it is provided to the volunteers.
The package containing the placebo is marked with the letter A and the package containing the medicine is marked with the letter B.
Blinding (investigator's opinion)
Double blinded
Blinding description
To blind the volunteers, cans containing drugs or placeboes marked with the letters A and B are used, so that no volunteers know in which group, treatment or control group, they have been placed.
Also, the memory tester does not have any information about which volunteers has taken the drug and which one has taken the placebo and only the statistical processor is aware of this information.
Placebo
Used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National Committee for Ethics in Biomedical Research
Street address
Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran, Iran
City
Tehran
Province
Golestan
Postal code
4971836735
Approval date
2018-10-08, 1397/07/16
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1397.127
Health conditions studied
1
Description of health condition studied
Increased memory in healthy volunteers
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Memory score of volunteers participating in Wechsler memory test
Timepoint
Baseline then re-measured after 6 weeks of drug use
Method of measurement
Wechsler memory test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: three times a day i.e in the morning,evening and at night, the volunteers of this group take one tablet containing 40 mg of Ginkgo Biloba dried extract with the brand name of Ginkgo T.D, For 6 weeks. The tablets are purchased from a pharmaceutical company, Tolid Daru.The volunteers are put through a memory test Before and after taking the drug, and the results obtained are compared to see how much it has been effective. Control group: the volunteers of this group take one tablet containing Avicel PH102 three times a day i.e. in the morning, the evening, and at night for 6 weeks, too. Placeboes are manufactured by Hakim Pharmaceutical Company.Before and after taking placebo, volunteers are tested for memory, and the results of these two intervention groups are statistical processing and review.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Hassan Yazdanpanah
Street address
School of Pharmacy, Valiasr Ave, Niayesh Cross, Tehran
City
Tehran
Province
Tehran
Postal code
1991953381
Phone
+98 21 8820 0118
Email
pr_pharmacy@sbmu.ac.ir
Web page address
http://pharmacy.sbmu.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Hassan Yazdanpanah
Street address
School of Pharmacy, Valiasr Ave, Niayesh Cross, Tehran
City
Tehran
Province
Tehran
Postal code
1991953381
Phone
+98 21 8820 0118
Email
pr_pharmacy@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Amin Attar
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Valiasr street، Hashemi Rafsanjani intersection، Shahid Beheshti school of pharmacy
City
Tehran
Province
Tehran
Postal code
1991953381
Phone
+98 17 3338 1583
Fax
Email
maattar1993@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Amin Attar
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Valiasr street، Hashemi Rafsanjani intersection، Shahid Beheshti school of pharmacy
City
Tehran
Province
Tehran
Postal code
1991953381
Phone
+98 17 3338 1583
Fax
Email
maattar1993@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Amin Attar
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Valiasr street، Hashemi Rafsanjani intersection، Shahid Beheshti school of pharmacy
City
Tehran
Province
Tehran
Postal code
1991953381
Phone
+98 17 3338 1583
Fax
Email
maattar1993@sbmu.ac.ir
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