Alzheimer is a progressive disease and estimated to affect approximately 40 million people worldwide. Although approved drugs are available for the management of Alzheimer disease, the outcomes are often unsatisfactory so for the effect of Boswellia serrata ( kondor) was evaluated in Iranian Alzheimer’s patients.
This study is a triple blind placebo controlled randomized clinical trial. The mild to moderate patients were selected and randomized to receive Boswellia capsules or placebo capsules for 3 months.they were evaluated by CDR (Clinical Dementia Rating) form at the first and every month up to 3 months.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015051822306N1
Registration date:2016-05-12, 1395/02/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-05-12, 1395/02/23
Registrant information
Name
Sara Asadi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3242 4128
Email address
asadi_s@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2015-05-22, 1394/03/01
Expected recruitment end date
2016-02-20, 1394/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the efficasy of Boswellia serrata on patients with mild to moderate Alzheimer disease
Public title
Evaluation the efficasy of Boswellia serrata on patients with mild to moderate Alzheimer disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: mild to moderate Alzheimer disease patients
Exclusion criteria: parkinson; multiple sclorosis; heart failure stage C and D of AHA/ACC classification; ischemic heart disease; uncontrolled hypertension; schizophrenia; active peptic ulcer; uncontrolled diabetes and alcohol abuse.
Age
From 45 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Central Building of Shiraz University of Medical Sciences, Zand St
City
shiraz
Postal code
Approval date
2015-06-14, 1394/03/24
Ethics committee reference number
IR.SUMS.REC.1394.49
Health conditions studied
1
Description of health condition studied
patients with mild to moderate Alzheimer
ICD-10 code
G30.9
ICD-10 code description
Alzheimer disease, unspecified
Primary outcomes
1
Description
memory
Timepoint
at the first and every month up to 3 months
Method of measurement
CDR (clinical dementia rating)
Secondary outcomes
empty
Intervention groups
1
Description
Control group:6 placebo capsules daily
Category
Treatment - Drugs
2
Description
Intervention group:6 kondor capsules daily
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Clinic
Full name of responsible person
Sara Asadi
Street address
Faculty of Pharmacy, Karafarin St.
City
shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Pouya Faridi
Street address
Traditional Pharmacy Department, Faculty of Pharmacy, Karafarin St.
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Shiraz University of Medical Sciences
Full name of responsible person
Sara Asadi
Position
pharmacy student
Other areas of specialty/work
Street address
Faculty of Pharmacy, Karafrin St.
City
Shiraz
Postal code
Phone
+98 71 3242 4128
Fax
Email
asadi_s@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Soha Namazi
Position
Professor of clinical Pharmacy
Other areas of specialty/work
Street address
RoknAbad Highway, Karafarin Avenu, School of Pharmacy, Pharmacotherapy Department, Shiraz, Iran
City
Shiraz
Postal code
Phone
+98 71 3242 4127
Fax
Email
namazisoha@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sara Asadi
Position
pharmacy student
Other areas of specialty/work
Street address
Faculty of Pharmacy, Karafarin St.
City
Shiraz
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)