This randomized, controlled clinical trial, was conducted to investigate the effect of the Iranian medicine called Vaj syrup (Acorus calamus) on the severity of mild to moderate Alzheimer's disease. Patients should be 50 to 80 years old and have a CDR score of less than or equal to 2 and an ADAS-COG score of 12 or higher to participate in the study. Exit criteria include chronic physical or psychosocial disorders other than Alzheimer's, and side effects of the drug. This study is performed on Alzheimer's patients referred to the Neurological Specialty Clinic whose diagnosis is definite by the neurologist, and the minimum sample size is 20 people. In this study, the intervention group, half an hour before each meal received the Vaj syrup. each time they received 10 mg with the common drug, and the control group received only the common medicine. The severity of Alzheimer's disease at baseline 4, 8 and 12 weeks after the intervention is measured using standard CDR and ADAS-COG questionnaires.Therefore, considering the effectiveness of this plant in improving memory and strengthening the brain in new articles and prescribing it in Iranian literature for years to strengthen memory and that there has not yet been any research on its efficacy in humans, it was decided that investigate the effect of Vaj syrup on a patient with Alzheimer's in a Clinical Trial.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017102030776N2
Registration date:2017-11-20, 1396/08/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-11-20, 1396/08/29
Registrant information
Name
Mohadese Kamali
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3211 2827
Email address
mohadesekamali0912@gmail.com
Recruitment status
Recruitment complete
Funding source
Traditional Medicine and History Research Center of Shiraz University of Medical Sciences
Expected recruitment start date
2017-10-23, 1396/08/01
Expected recruitment end date
2018-01-20, 1396/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Vaj (Acorus calamus) syrup on mild to moderate Alzheimer's disease in patients referring to the neurology clinic
Public title
The effect of a Vaj (Acorus calamus) syrup on Alzheimer's
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: aged over 50 years؛ CDR score less than or equal to 2؛ ADAS-COG score greater than or equal to 12؛ no heart disease؛ no high blood pressure؛ no drug abuse and alcohol dependency؛Non use of anticoagulants؛ no diabetes -ability to participate in the study؛ no more than 80 years old؛ definite Alzheimer's disease
Outcome criteria : bipolar disorder ِِ؛ mild to severe depression ؛ co-morbidity with other neurological diseases ؛ inability to participate in the study؛ Inability to continue treatment ؛ causing side effects
Age
From 46 years old to 16 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Faculty of Medicine, Traditional Medicine Research Center and Medical History, Zand Avenue, Shiraz, Iran
City
Shiraz
Postal code
7134845794
Approval date
2016-12-10, 1395/09/20
Ethics committee reference number
IR.SUMS.REC.1395.82
Health conditions studied
1
Description of health condition studied
Alzheimer
ICD-10 code
G32
ICD-10 code description
Other degenerative disorders of nervous system in diseases classified elsewhere
Primary outcomes
1
Description
Severity of Alzheimer
Timepoint
four, eight, twelve weeks after intervention
Method of measurement
CDR and ADAS-COG questionnaire
Secondary outcomes
1
Description
side effects
Timepoint
four, eight, twelve weeks after intervention
Method of measurement
Self-made questionnaire
Intervention groups
1
Description
The control group is only used common drug (galantamine pill, rivastigmine capsule or danepzil tablet) for 12 weeks.
Category
Treatment - Drugs
2
Description
Intervention group was received Vaj syrup half an hour before each meal, each time they received 10 mg with the common medicine.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat clinic 4
Full name of responsible person
Mohadese Kamali
Street address
The end of Shahid rajaee street, Kerman
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Traditional Medicine and History Research Center of Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mahdi Pasalar
Street address
Faculty of Medicine, Traditional Medicine Research Center and Medical History, Zand Avenue, Shiraz, Iran
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Traditional Medicine and History Research Center of Shiraz University of Medical Sciences
Proportion provided by this source
100
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
Kerman University of Medical Sciences, School of Persian Medicine
Full name of responsible person
Mohadese Kamali
Position
Ph.D Persian Medicine
Other areas of specialty/work
Street address
The Pardis of Persian Medicine, Modiriat street
City
Kerman
Postal code
Phone
+98 34 3312 2020
Fax
+98 34 3312 2023
Email
mohadesekamali0912@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences, School of Persian Medicine
Full name of responsible person
Mohadese Kamali
Position
Ph.D Persian Medicine
Other areas of specialty/work
Street address
The Pardis of Persian medicine, Modiriat street
City
Kerman
Postal code
Phone
+98 34 3312 2020
Fax
+98 34 3312 2023
Email
mohadesekamali0912@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences, School of Persian Medicine
Full name of responsible person
Mohadese Kamali
Position
Ph.D Persian Medicine
Other areas of specialty/work
Street address
The Pardis of Persian medicine, Modiriat street
City
Kerman
Postal code
Phone
+98 34 3312 2020
Fax
+98 34 3312 2023
Email
mohadesekamali0912@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)