Determination of the effect of standard hydroalcoholic extract of soybean (Glycine max L.)seeds on Alzheimer's disease severity
Design
After diagnosis of mild to moderate Alzheimer's, subjects are randomly divided into placebo and intervention groups. The control group received placebo and the soy capsule intervention group. In the form of soy capsules, a 500-mg capsule should be given every 8 hours (0.5 g daily dose). The control group also received a 500 mg capsule without extracts Receive every 8 hours for one month.
Settings and conduct
This study was designed as a randomized clinical trial of Shahandar-doorkour which is carried out after obtaining the necessary permissions and obtaining written informed consent by visiting the nursing home of Kerman.
Participants/Inclusion and exclusion criteria
For the study of people over the age of fifty years who have been diagnosed with Alzheimer's disease by a neurologist based on the NINCDS-ADRDA criteria, and after this clinical interview, a neurological examination of psychological tests is performed from patients. In this method, patients with mild Alzheimer's disease They are selected to an average.
Intervention groups
The intervention group received capsules containing soybean seeds extract powder (500 mg capsule every 8 hours). The dose of the drug is 1.5 grams per day. The control group received 500 mg of starch powder capsuls every 8 hours for 8 weeks.
Main outcome variables
Determination of mental status and cognitive function of patients with Alzheimer's disease before intervention, four weeks and eight weeks later in intervention and control group
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170702034861N9
Registration date:2019-10-18, 1398/07/26
Registration timing:registered_while_recruiting
Last update:2019-10-18, 1398/07/26
Update count:0
Registration date
2019-10-18, 1398/07/26
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
2019-07-23, 1398/05/01
Expected recruitment end date
2019-10-22, 1398/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical evaluation of the effect of standard hydroalcoholic extract of soybean seeds (Glycine max L.) on Alzheimer's disease severity.
Public title
Effect of Soybean on Alzheimer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 50 years old
Having a MMSE score between 16 and 24
Lack of substance abuse and alcohol abuse
Do not use anticoagulants
Lack of heart disease
Exclusion criteria:
depession
Age
From 50 years old to 85 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization of this study was performed by a quadratic block design by Random allocation software and a biostatistics specialist. Subjects with mild to moderate Alzheimer's disease and having appropriate conditions were divided into intervention and control groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study is double-blind, meaning the researcher and study participants do not know who is in the drug group and who is in the placebo group.
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
Deputy of Research and Technology of Kerman University of Medical Sciences, Shariati St.
City
Kerman
Province
Kerman
Postal code
76175-493
Approval date
2019-08-25, 1398/06/03
Ethics committee reference number
IR.KMU.REC.1398.255
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
90-60-0day
Method of measurement
MMSD and CDR questionnair
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group will receive the soybean capsule. Get help with the capsule shape You can eat in your 500ml capsule every 8 hours.
Category
Treatment - Drugs
2
Description
Control group: The placebo group received starch every 8 hours for three months.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
The old people's homes
Full name of responsible person
Zeynab Pour Ramazan
Street address
Beginning of the Axis of the Seven Gardens of Alavi, Campus of the University of Medical Sciences, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
nakisa.1995@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
Beginning of the axis of seven Alavi Gardens, Campus of the University of Medical Sciences, Faculty of Pharmacy
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
fsharififar@kmu.ac.ir
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
Zeynab Pour Ramezan
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
nakisa.1995@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
the beginning of the axis of the 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
Zeynab pour Ramezan
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
nakisa.1995@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