The Effectiveness of the adjuvant treatment with a compound of sedge plant, saffron and honey to conventional treatment for improvement of cognitive performance of patients with dementia
This is a double-blinded clinical trial study, which assessment person and drug delivery person were not aware about drug and placebo and the patients were not aware bout the groups. The patients were selected from geriatric clinic (60 patients), and divided randomly into intervention group (30 patients) and control group (30 patients). Inclusion criteria: Upper 50 years old; slight to moderate dementia; according DSM-IV criteria; acceptance to enter this project; under drug therapy. Exclusion criteria: Mental retardation depend on DSM-IV criteria; Side effect that patients couldn’t continue these herbal drugs such as gastrointestinal side effect; other psychiatrist disorder; using other herbal medicine, or using other traditional treatment such as homeopathy. For intervention group, daily consumption 50 mg sedge and 30 mg saffron and honey for 3 months was prescribed. And for control group same dosage placebo was prescribed. Adenborok scale for cognitive assessment and GDS for depression assessment, before intervention, the first moth of intervention and the second months of the intervention was used.
General information
Acronym
ADT
IRCT registration information
IRCT registration number:IRCT2016101030255N1
Registration date:2017-01-20, 1395/11/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-01-20, 1395/11/01
Registrant information
Name
Victoria Omranifard
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3222 2475
Email address
v_omranifard@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2015-04-04, 1394/01/15
Expected recruitment end date
2016-09-20, 1395/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of the adjuvant treatment with a compound of sedge plant, saffron and honey to conventional treatment for improvement of cognitive performance of patients with dementia
Public title
The Effectiveness of the adjuvant treatment with a compound of sedge plant, saffron and honey to conventional treatment for improvement of cognitive performance of patients with dementia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1-Upper 50 years old; 2-slight to moderate dementia according DSM-IV criteria; 3-acceptance to enter this project; 4-under drug therapy.
Exclusion criteria: 1-Mental retardation according DSM-IV criteria; 2-Side effect that patients couldn’t continue these herbal drugs such as gastrointestinal side effect; 3-other psychiatrist disorder; 4-using other herbal medicine, or using other traditional treatment such as homeopathy.
Age
From 49 years old to 100 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Ethics Committee Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar jerib Street, Davazeh Shiraz, Isfahan
City
Isfahan
Postal code
Approval date
2016-04-03, 1395/01/15
Ethics committee reference number
IR.MUI.REC.1395.3.043
Health conditions studied
1
Description of health condition studied
Dementia in Alzheimer disease with late onset
ICD-10 code
G30.1
ICD-10 code description
Dementia in Alzheimer disease with late onset
Primary outcomes
1
Description
cognitive function
Timepoint
before treatment-first month and second month of treatment
Method of measurement
Adenbrok scale
Secondary outcomes
1
Description
depression
Timepoint
before-first month and second month of treatment
Method of measurement
Global depression scale
Intervention groups
1
Description
During the 3 months , 50 mg sedge and 30 mg honey with saffron for treatment group.
Category
Treatment - Drugs
2
Description
During the 3 months , 50 mg starch instead of sedge and 30 mg candy juice instead of honey with saffron for control group.