Protocol summary

Summary
Mild cognitive impairment are the first stage of dementia. Due to the progression of irreversible dementia, the best time to do any preventative action is the MCI stage. Currently, an effective treatment has not been confirmed at this stage. BosweiliaSerrata, so far,had been used for enhancing memory and learning skills among Iranian and Muslims . The present study aimed to investigate the effect of Bosweilia Serrata on the improvement of mild mental impairment (MCI) . In a randomized double-blind clinical trial, in Kerman in southeastern Iran 80 patients were enrolled in the intervention group and the placebo group. At baseline, after evaluation by Moca test, they were received intervention and were followed-up for 3 months and then were evaluated again . finally groups were compared by statistic tests.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201402088430N8
Registration date: 2015-03-12, 1393/12/21
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-03-12, 1393/12/21
Registrant information
Name
Farhad Iranmanesh
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 1226 2629
Email address
fpp_farhad@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Kerman University of Medical Sciences
Expected recruitment start date
2014-06-22, 1393/04/01
Expected recruitment end date
2014-09-23, 1393/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between treatment with Bosweilia Serrata versus placebo in improving Mild cognitive dementia (MCI)
Public title
Effect of Bosweilia Serrata in treatment of Mild cognitive dementia (MCI)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Confirmation of MCI related to Peterson criterion; Lack of contraindication for taking Bosweili ; Points less than 7 in BECK test ; Normal brain MRI Exclusion criteria:Not MCI related to Peterson criterion; contraindication to taking Bosweili ; Points more than 7 in BECK test ;Abnormal brain MRI
Age
From 55 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
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 of Kerman University
Street address
Shafa Intersection ,Islamic Repubic of Blvd,Kerman
City
kerman
Postal code
7619813159
Approval date
2013-08-23, 1392/06/01
Ethics committee reference number
کا/315/92

Health conditions studied

1

Description of health condition studied
Dementia NOS
ICD-10 code
F03
ICD-10 code description
unclassified dementia

Primary outcomes

1

Description
MCI ( mild mental impairment )
Timepoint
Baseline & 3months after the intervention
Method of measurement
MOCA test

Secondary outcomes

1

Description
Evaluation of improving MCI
Timepoint
After 3 months intervention
Method of measurement
MOCA test

Intervention groups

1

Description
"Intervention group" : capsule Bosweilia, 300mg, BID , 3 months
Category
Treatment - Drugs

2

Description
"Control group" : capsule placebo, BID ,3months
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shafa Training & Sciences Center
Full name of responsible person
Doctor behnaz sedighii
Street address
Shafa Street ,Islamic Republic of BLV,Kerman
City
kerman

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of kerman University of Medical Sciences
Full name of responsible person
Hosseinali Ebrahimi
Street address
Center for Neuroscience Research ,Shafa Hospital ,Shafa Street,Kerman
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of kerman 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 and Heaith Services
Full name of responsible person
Kave Shafii
Position
Assistant professor
Other areas of specialty/work
Street address
Islamic Republic of BLV.kerman
City
kerman
Postal code
7618751151
Phone
+98 34 3211 5780
Fax
+98 34 3211 5817
Email
shafahospital@kmu.ac.ir
Web page address
htt://shafah.kmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences and Heaith Services
Full name of responsible person
Soheila Rezakhani
Position
Neurology Assistant
Other areas of specialty/work
Street address
Shafa Hospital,Kerman
City
kerman
Postal code
7618751151
Phone
+98 34 3211 5780
Fax
+98 34 3211 5817
Email
drrezakhani@gmail.com ; shafa hospital@kmu.ac.ir
Web page address
htt://shafah.kmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences and Heaith Services
Full name of responsible person
Soheila Rezakhani
Position
Neurology Assistant
Other areas of specialty/work
Street address
Shafa HospitaL ,Kerman
City
Kerman
Postal code
7618751151
Phone
+98 34 3211 5780
Fax
+98 34 3211 5817
Email
drrezakhani@gmail.com ; shafa hospital@kmu.ac.ir
Web page address
htt://shafah.kmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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