During a double blind placebo controlled clinical trial, from patients referred to neurology clinic of Emam Reza hospital in city of Kermanshah, 100 patients with a one year history of definite diagnosis of dementia, who fulfill criteria of the study will be enrolled and will be divided into intervention and control groups. After description of the study goals and receiving informed consent patients in the intervention group will receive 140 mg silymarin tablets (with trade name Livergol, Goldaru company) , three times a day and patients in control group will receive placebo tablets identical to silymarin tablets, three times a day for 12 weeks. Patient's memory state will be examined before and after 12 weeks intervention using mini mental state examination scale (MMSE scale). Any patient who meets the study exclusion criteria during the intervention will be excluded, and patient enrollment will be continued until reaching study sample size. At last data will be analyzed by statistical software to evaluate effectiveness oral silymarin.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201505091856N5
Registration date:2015-05-22, 1394/03/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-05-22, 1394/03/01
Registrant information
Name
Dariush Afshari
Name of organization / entity
Kermanshah University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 83 1835 0177
Email address
dafshari@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
kermanshah university of medical sciences
Expected recruitment start date
2015-05-09, 1394/02/19
Expected recruitment end date
2016-06-19, 1395/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the evaluation of effectiveness of oral silymarin on memory status of patients with dementia
Public title
the evaluation of effectiveness of oral silymarin on memory status of patients with dementia
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria:
1. definite diagnosis of dementia by an experienced neurologist
2. at least one year has past form the time of the diagnosis
exclusion criteria:
1. illiterate persons
2. having epilepsy, cardiovascular diseases, metabolic diseases, respiratory diseases, orthopedic problems and renal failure with serum cratinin level more than 2
3. history of previous stroke
4. acute and severe state of any disease including stroke, pulmonary infection, renal disease, metabolic disturbance or trauma leading to hospitalization during the study
5. using other self care programs that are effective on memory state of patents at the same time of study intervention
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kermanshah University of Medical Sciences
Street address
Kermanshah University of Medical Sciences, Shahid Beheshti boulvered, Kermanshah
City
Kermanshah
Postal code
Approval date
2014-11-11, 1393/08/20
Ethics committee reference number
35213
Health conditions studied
1
Description of health condition studied
Dementia in Alzheimer disease
ICD-10 code
F00
ICD-10 code description
Alzheimer disease is a primary degenerative cerebral disease of unknown etiology with characteristic neuropathological and neurochemical features. The disorder is usually insidious in onset and develops slowly but steadily over a period of several years.
2
Description of health condition studied
Vascular dementia
ICD-10 code
F01
ICD-10 code description
Vascular dementia is the result of infarction of the brain due to vascular disease, including hypertensive cerebrovascular disease. The infarcts are usually small but cumulative in their effect. Onset is usually in later life.
3
Description of health condition studied
Dementia in other diseases classified elsewhere
ICD-10 code
F02
ICD-10 code description
Cases of dementia due, or presumed to be due, to causes other than Alzheimer disease or cerebrovascular disease. Onset may be at any time in life, though rarely in old age.
Primary outcomes
1
Description
memory status of patients
Timepoint
before and 12 weeks after intervention
Method of measurement
mini mental state examination scale
Secondary outcomes
1
Description
drug side effects
Timepoint
12 weeks after intervention
Method of measurement
history and physical examination
Intervention groups
1
Description
Silymarin, 140 mg tablets, 3 times a day (trade name, Livergol, goldaru company), for 12 weeks
Category
Treatment - Drugs
2
Description
Placebo tablets identical to silymarin tablets in shape and color, 3 times a day, for 12 weeks.
Placebo tablets are made in pharmacology faculty of kermanshah university of medical sciences.