The purpose of this research is study of therapeutic effect of curcumin in clinical signs and quality of life in mild Alzheimer's disease.Trial is randomized , double blinded(for patients) and control with placebo.groups of study are mild to moderate Alzheimer's disease and patients that have psychic disorder become out of study. two groups of 35 patients for 12 weeks in addition to routine treatment , treat by curcumin capsule (500 mg twice a day) or placebo.Major indexes at the beginning and end of study are MMSE and quality of life questionnaires.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201507271165N11
Registration date:2015-09-24, 1394/07/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-09-24, 1394/07/02
Registrant information
Name
Yunes Panahi
Name of organization / entity
Baqiyatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8821 1524
Email address
yunespanahi@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Baghiyatallah University of Medical Sciences, Chemical Injeries Research Center
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2015-11-22, 1394/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Therapeutic effect of curcumin in symptoms of mild to moderate Alzheimer's disease
Public title
Effect of curcumin (tumeric) in Alzheimer's disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria : Sign informed consent ; mild Alzheimer; with out any of psychic disorder
Exclusion Criteria : Discontinue of treatment more than 2 weeks ; disese becomes out of control ; allergic reaction to herbal compounds ,abnormal results in lab tests
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomized and double blinded and control with placebo( for patients)
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Baghiyatallah University of Medical Sciences
Street address
Mollasadra street,Vanak square
City
Tehran
Postal code
Approval date
2015-07-05, 1394/04/14
Ethics committee reference number
ir.bmsu.rec.1394.61
Health conditions studied
1
Description of health condition studied
Alzheimer's disease
ICD-10 code
G30.1
ICD-10 code description
Alzheimer disease with late onset
Primary outcomes
1
Description
Improvment of mental state
Timepoint
before and after of intervention (12 weeks)
Method of measurement
MMSE questionaire
2
Description
Improvment of quality of life
Timepoint
before and after of intervention (12 weeks)
Method of measurement
quality of life questionnaire
Secondary outcomes
1
Description
Interleukin18 (IL18)
Timepoint
befor and after of intervention(12 weeks)
Method of measurement
level of serum
2
Description
superoxide dismutase (SOD)
Timepoint
before and after of intervention(12 weeks)
Method of measurement
level of serum
3
Description
Glutathione peroxidase (GPO)
Timepoint
before and after of intervention(12 weeks)
Method of measurement
level of serum
4
Description
malondialdehyde(MDA)
Timepoint
befor and after of intervention(12 weeks)
Method of measurement
level of serum
Intervention groups
1
Description
intervention group: curcumin capsule, twice a day for 12 weeks
Category
Treatment - Drugs
2
Description
control group:placebo of curcumin, twice a day for 12 weeeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Baghiyatallah Hospital
Full name of responsible person
Dr Yunes Panahi
Street address
Mollasadra Street, Vanak Square
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Baghiyatallah University of Medical Sciences, Chemical Injeries Research Center
Full name of responsible person
Dr Yunes Panahi
Street address
Mollasadra Street, Vanak Square
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Baghiyatallah University of Medical Sciences, Chemical Injeries Research Center
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
Pharmaceutical Sciences Branch Islamic Azad University
Full name of responsible person
Mahsa Bakhtiyari
Position
Pharm.D
Other areas of specialty/work
Street address
Yakhchal Street, Gholhak, Shariati Street
City
Tehran
Postal code
Phone
+98 21226400515
Fax
Email
publicrelation@iaups.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Baghiyatallah University of Medical Sciences, Chemical Injeries Research Center
Full name of responsible person
Dr Yunes Panahi
Position
Ph.D of Clinical Pharmacy
Other areas of specialty/work
Street address
Mollasadra Street, Vanak Square
City
Tehran
Postal code
Phone
+98 21 8821 1524
Fax
Email
yunespanahi@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)