object:The effect of tablet containing Boswellia serrata extract and Mellisa officinalis extract on memory of the elderly Study design: a clinical trial, randomized, double blind, control with Placebo. Main inclusion and exclusion criteria: Inclusion criteria: Informed consent and willingness to participate in the study; Age 60 to 75 years.Exclusion criteria: Complications such as severe headache, nausea and vomiting, severe digestive problems; Irregular consumption Tablets; Alzheimer's and other mental disorders; trauma or stroke; a history of sensitivity to herbal medicines; Hearing and vision problems. sample size: 80 persons. Intervention: Intervention group take herbal pills containing Boswellia serrata extract and Mellisa officinalis extract twice a day, each time taking a pill for two months and Similarly control group take placebo. Outcome: Improve memory.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015102114086N6
Registration date:2016-06-24, 1395/04/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-06-24, 1395/04/04
Registrant information
Name
Mohammad Aghajani
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 2001
Email address
aghajani_m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Barij Essence Pharmaceutical company
Expected recruitment start date
2016-01-21, 1394/11/01
Expected recruitment end date
2016-04-20, 1395/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of tablet containing Boswellia serrata extract and Mellisa officinalis extract on memory of the elderly
Public title
The effect of tablet containing Boswellia serrata extract and Mellisa officinalis extract on memory of the elderly
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Informed consent and willingness to participate in the study; Age 60 to 75 years; Full consciousness.
Exclusion criteria: Complications such as severe headache, nausea and vomiting, severe digestive problems; Irregular consumption Tablets (Two consecutive meals or two servings of total); Alzheimer's and other mental disorders; drug abuse, alcohol and psychotropic drugs; trauma or stroke; a history of sensitivity to herbal medicines; Hearing and vision problems that interfere with the elderly.
Age
From 60 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
randomization is based on block randomization thus elderly peoples are divided into two equal groups with blocks of 4 times.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences and Health Services
Street address
Ethics committee, Research Committee, Kashan University of Medical Sciences, Ghotb e Ravandi Blvd., Kashan, Iran
City
Kashan
Postal code
Approval date
2015-02-09, 1393/11/20
Ethics committee reference number
9413
Health conditions studied
1
Description of health condition studied
Memory
ICD-10 code
R41.3
ICD-10 code description
Other amnesia
Primary outcomes
1
Description
Immediate Memory
Timepoint
Before intervention, After intervention
Method of measurement
Wechsler Memory Scale III
2
Description
Working Memory
Timepoint
Before intervention, After intervention
Method of measurement
Wechsler Memory Scale III
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: tablet containing Boswellia serrata extract and Mellisa officinalis extract ( 220 m/g) twice a day, for two months
Category
Treatment - Drugs
2
Description
control group: pills without effective material twice a day, for two months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Health centers of Kashan University odf Medical Science
Full name of responsible person
Maliheh Rahmani
Street address
Ravand,Kashan University odf Medical Science,
City
Kashan
2
Recruitment center
Name of recruitment center
Shahid Sadoghi of Kashan universyu of medical science
Full name of responsible person
Street address
Rahahan street, Jandarmeri avenue
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Barij Essence CO.
Full name of responsible person
Dr. Mohsen Tghizadeh
Street address
Mashhad Ardehal - Kashan
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Barij Essence CO.
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Kashan University of Medical Sciences and Health Services
Full name of responsible person
Dr. Gholamali Hamidi
Street address
Vice chancellor for research of Kashan University of Medical Sciences and Health Services, Pezeshk Blvd, 5th of Qotbe Ravandi Blvd, Kashan
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences and Health Services
Proportion provided by this source
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
Name of organization / entity
Kashan University of Medical Sciences and Health Services
Full name of responsible person
Maliheh Rahmani
Position
M.Sc Candidate in Clinical Psychology
Other areas of specialty/work
Street address
Department of Clinical Psychology, School of Medicine, Kashan University of Medical Sciences and Health Services, Pezeshk Blvd, 5th of Qotbe Ravandi Blvd, Kashan
City
Kashan
Postal code
Phone
+98 31 5554 8655
Fax
Email
aghajani1362@yahoo.com,rahmani-ma@kaums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences and Health Services
Full name of responsible person
Mohammad Aghajani
Position
M.Sc in Psychiatric Nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Kashan University of Medical Sciences and Health Services, Pezeshk Blvd, 5th of Qotbe Ravandi Blvd, Kashan
City
Kashan
Postal code
Phone
+98 31 5554 0021
Fax
Email
aghajani_m@kaums.ac.ir, aghajani1362@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences and Health Services
Full name of responsible person
Maliheh Rahmani
Position
M.Sc Candidate in Clinical Psychology
Other areas of specialty/work
Street address
Department of Clinical Psychology, School of Medicine, Kashan University of Medical Sciences and Health Services, Pezeshk Blvd, 5th of Qotbe Ravandi Blvd, Kashan
City
Kashan
Postal code
Phone
+98 31 5554 0021
Fax
Email
rahmani1300@gmail.com, rahmani-ma@kaums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)