Determination of the effectiveness of Memoral herbaceous medicine on improvement of cognitive functions in patients with Alzheimer
Design
Clinical trial with parallel group design of 90 patients, two arm, blinded, randomization using simple randomization, phase 3
Settings and conduct
patients who visit emam Reza hospital and by the lab and imaging method confirmed alzheimer disease , be investigated.then patients randomly divide in 2 groups by simple randomization method.in such a way that the patients coded by even and odd number according to time of referral and patients whose code is even or odd are placed in the intervention or control group one by one without the knowledge of the person delivering the medicine and the patient herself..the executor put medicine in the closed envelope which the code and the patient's name are written on it. Then give them to medicine delivery. The delivery don't informed about envelope's content and patient also don't informed about medicine's name.this study is double blinded so patients and executor were keep blinded .
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients who alzheimer disease confirmed by imaging and lab results.
Non-inclusion criteria: Patients suffering from other disease such as other dementia which imitate alzheimer disease; patients with contraindications to the drug such as pregnancy; patients who have taken other drugs to control alzheimer disease.
Intervention groups
Intervention group receive Memoral capsule (GOLDARU company product) BD with Donepezil 5 mg tablet BD. Control group receive placebo capsule BD with Donepezil 5 mg tablet BD for 3 months.
Main outcome variables
Cognitive functions based on Addenbrooke examination questionnaire
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200204046367N1
Registration date:2020-04-21, 1399/02/02
Registration timing:registered_while_recruiting
Last update:2020-04-21, 1399/02/02
Update count:0
Registration date
2020-04-21, 1399/02/02
Registrant information
Name
sadaf qafari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3724 4137
Email address
s1d9fgh9f4ry@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-20, 1399/02/01
Expected recruitment end date
2020-07-22, 1399/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of Memoral herbaceous medicine and placebo in improving cognitive functions in Alzheimer patients
Public title
The effect of Memorial in Alzheimer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmation of Alzheimer's disease according to imaging and laboratory results
Exclusion criteria:
Patients suffering from other disease such as other dementia which imitate alzheimer disease
patients with contraindications to the drug such as pregnancy
patients who have taken other drugs to control alzheimer disease
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Patients randomly divided in two groups by simple randomization method.in such a way that the patients coded by even and odd number according to time of referral and patients whose code is even or odd are placed in the intervention or control group one by one without the knowledge of the person delivering the medicine and the patient herself.
Blinding (investigator's opinion)
Double blinded
Blinding description
The executor put medicine in the closed envelope which the code and the patient's name are written on it. Then give them to medicine delivery. The delivery don't informed about envelope's content and patient also don't informed about medicine's name.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
No 26, 120 alley; Daraii treet
City
Kermanshah
Province
Kermanshah
Postal code
6718833134
Approval date
2020-03-03, 1398/12/13
Ethics committee reference number
IR.KUMS.REC.1398.1189
Health conditions studied
1
Description of health condition studied
Alzheimer
ICD-10 code
G30
ICD-10 code description
Alzheimer's disease
Primary outcomes
1
Description
Cognitive function scores based on Addenbrooke’s Cognitive Examination questionnaire
Timepoint
At the beginning of the study and 3 months after beginning of Memoral usage
Method of measurement
Addenbrooke’s Cognitive Examination questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Memoral capsule (GOLDARU company product) BD with Donepezil 5 mg tablet BD for 3 months
Category
Treatment - Drugs
2
Description
Control group: placebo capsule BD with Donepezil 5 mg tab BD for 3 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza hospital
Full name of responsible person
Sadaf Qafari
Street address
Zakariya Razi boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6742775333
Phone
+98 83 3427 6300
Email
irhk@kums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Farid Najafi
Street address
Department number 2, Shahid Behshti boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3838 4185
Email
farid_n32@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Sadaf Qafari
Position
Intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No.26; 120 alley; Daraii street; Ferdowsi square
City
Kermanshah
Province
Kermanshah
Postal code
6718833134
Phone
+98 83 3724 4137
Fax
Email
s1d9fgh9f4ry@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Sadaf Qafari
Position
Intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No.26; 120 alley; Daraii street; Ferdowsi square
City
Kermanshah
Province
Kermanshah
Postal code
6718833134
Phone
+98 83 3724 4137
Fax
Email
s1d9fgh9f4ry@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Sadaf Qafari
Position
Intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No.26; 120 alley; Daraii street; Ferdowsi square
City
Kermanshah
Province
Kermanshah
Postal code
6718833134
Phone
+98 83 3724 4137
Fax
Email
s1d9fgh9f4ry@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
Undecided - It is not yet known if there will be 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
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available