Investigation of physicochemical properties and clinical effects of Capsule containing standardized hydroalcoholic extract of myrtus communis L. leaves in the treatment of mild to moderate Alzheimer's disease (AD): A randomized double-blind placebo controlled trial
Clinical effects of the standardized hydro-alcoholic extract of Myrtus communis L. in mild to moderate alzheimer's disease: (AD): a randomized double-blind placebo controlled trial
Design
The study groups consisted of the control group (placebo) and the intervention group (herbal medicine) and randomly assigned by random allocation software in two groups. Number of patients in each group is 25.
Settings and conduct
This study was designed as a double blinded placebo- controlled randomized by simple method, clinical trial which is performed after obtaining the necessary permissions and obtaining written informed consent by referring to the nursing home of Kerman. People over the age of fifty whose Alzheimer's disease is diagnosed by a neurologist based on the NINCDS-ADRDA criteria (National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association) is evaluated by the psychologist after examination by neurology and rejection of mimicking causes such as depression by the Mini-Mental State Exam test (MMST) and clinical dementia rating (CDR). After diagnosis of laboratory tests and imaging, Alzheimer's diagnosis is selected from patients with mild to moderate Alzheimer's disease.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
-Age 50 to 80 years
-MMSE score between 16 and 24
-No drug abuse and alcohol dependence
-Not taking anticoagulants
-Ability to answer questions and no mental problems
-Exclusion criteria:
-Depression
Intervention groups
Control group, placebo and intervention group received myrtus capsule (500 mg capsule every 8 hours)
For one month.
Main outcome variables
Determination of the mental status and cognitive function of patients with Alzheimer before intervention and 4 weeks after intervention in the intervention and control group.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170702034861N8
Registration date:2019-08-26, 1398/06/04
Registration timing:retrospective
Last update:2019-08-26, 1398/06/04
Update count:0
Registration date
2019-08-26, 1398/06/04
Registrant information
Name
Fariba Sharififar
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5020
Email address
fsharififar@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-22, 1397/09/01
Expected recruitment end date
2019-08-22, 1398/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of physicochemical properties and clinical effects of Capsule containing standardized hydroalcoholic extract of myrtus communis L. leaves in the treatment of mild to moderate Alzheimer's disease (AD): A randomized double-blind placebo controlled trial
Public title
Study of the effect of myrtus communis L.extract on Alzheimer's disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 50 to 85 years
MMSE score between 16 and 24
No drug abuse and alcohol dependence
Not taking anticoagulants
Ability to answer questions and no mental problems
Exclusion criteria:
depression
Age
From 50 years old to 85 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into two groups using Simple Randomization
(Group 1 received Capsule containing standardized hydroalcoholic extract of myrtus communis L. leaves and group 2 received placebo). A random number table is used to equalize the number of patients in each group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study is double-blind, meaning that the questionnaire and the participant in the study do not know how the drug and placebo are allocated.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kerman University of Medical Sciences
Street address
Shariati St. - Deputy of Research and Technology of Kerman University of Medical Sciences
City
kerman
Province
Kerman
Postal code
76175-493
Approval date
2019-01-26, 1397/11/06
Ethics committee reference number
IR.KMU.REC.1397.358
Health conditions studied
1
Description of health condition studied
Alzheimer's disease
ICD-10 code
G30-G32
ICD-10 code description
Other degenerative diseases of the nervous system
Primary outcomes
1
Description
• Cognitive status of patients
Timepoint
Before and after 4 weeks of intervention
Method of measurement
Mini-Mental State Exam (MMSE) and Clinical Dementia Rating (CDR)questionnair
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: A 500 mg capsule containing an extract of myrtus communis, which was made by Pharmacognosist at the Kerman Pharmaceutical Faculty, was received every 8 hours for four weeks.
Category
Treatment - Drugs
2
Description
Control group: A 500 mg capsule containing Starch powder , which was made by Pharmacognosist at the Kerman Pharmaceutical Faculty, was received every 8 hours for four weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
The old people `s home of Mehr Azin, Iran, Kerman
Full name of responsible person
Pegah Nooraee
Street address
No.17 Alley, Motahari street
City
Kerman
Province
Kerman
Postal code
7618843552
Phone
+98 34 3311 5120
Email
pegahn73p@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr. Fariba Sharififar
Street address
Campus of Medical Sciences, Beginning of the axis of seven Alavi Gardens
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
pegahn73p@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Pegah Nooraee
Position
General pharmacy student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Campus of the University of Medical Sciences, Beginning of the axis of seven Alavi Gardens
City
Kerman
Province
Kerman
Postal code
7619613555
Phone
+98 34 3132 5600
Email
pegahn73p@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Fariba Sharififar
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Beginning of the axis of seven Alavi Gardens, Campus of the University of Medical Sciences, Faculty of Pharmacy
City
Kerman
Province
Kerman
Postal code
7619613555
Phone
+98 34 3132 5600
Email
fsharififar@kmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Pegah Nooraee
Position
General pharmacy student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Beginning of the axis of seven Alavi Gardens, Campus of the University of Medical Sciences, Faculty of Pharmacy
City
Kerman
Province
Kerman
Postal code
7619613555
Phone
+98 34 3132 5600
Email
pegahn73p@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available