Protocol summary

Summary
Dementia as a chronic progressive disorder is one of the main causes of disability in the old age that is associated with an epidemic and significant increase in recent years. The main symptom of dementia is progressive forgetfulness that gradually leads to disorders in thinking, judgment, orientation, learning, language, behavior and mood. Treatments include psychological therapies (cognitive, behavioral and supportive therapy) or cholinesterase inhibitors, NMDA receptor agonist and psychotropic drugs. In addition to the complications of medications, we have little Improvement and no effect on the course of the disease. That is why the traditional and complementary approaches have been developed . The word "Nesyan" in traditional term means to forget what was learned or inability to learn, which is similar to the modern concept of dementia. The cause in traditional term is dysfunction of the cerebral forces (Memory, thinking and imagination). "Ostokhodus" according to Iranian sages is a unique drug in empowering the brain, very effective in purification and purification, Nourishing mental and intellectual forces and useful in neuronal diseases. Recent studies in animal models proved it as a heating, antioxidant herbal remedy with anti-cholinesterase inhibitory effects. Therefore, this medicinal species selected to prove its effectiveness in human studies.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015051022195N1
Registration date: 2015-11-15, 1394/08/24
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-11-15, 1394/08/24
Registrant information
Name
azam abdolahadi
Name of organization / entity
traditional faculty of shahid beheshti medical univercity
Country
Iran (Islamic Republic of)
Phone
+98 21 8877 3521
Email address
dr.abdolahadi@gmail.com
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2015-07-23, 1394/05/01
Expected recruitment end date
2016-03-10, 1394/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Explanation of "Nesyan" in Iranian traditional medicine and study of effects of extract of Nepeta menthoides Boiss and Buhse on cognitive disorders in dementia a double blind clinical trial with placebo
Public title
Effects of Nepeta menthoides Boiss and Buhse on cognitive disorders in Dementia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age 65 to 85 years; Dementia diagnosis based on the baseline MMSE score less than 20 in the questionnaire by the psychiatrist; Have at least five classes of literacy; Obtain informed consent from the patient or the patient's guardian; No psychiatric disorder other than Alzheimer's disease according to a specialist such as depression and other diseases; Lack of substance abuse or drugs (except nicotine and caffeine); AChE inhibitors allergy history; History of heart disease, seizure, asthma, peptic ulcer, urinary tract obstruction; Reporting the warmth of humor based on valid and reliable questionnaire doctor Mujahid. Exclusion criteria: Drug side effects; Tend to withdraw from the project at any stage of the investigation.
Age
From 65 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
Shahid Beheshti University of Medical Sciences
Street address
7th Floor , 2nd SBUMS Bldg. ,Next to Ayatollah Taleghani Hospital, Evin , Tehran, Iran. Post code: 198396-3113
City
Tehran
Postal code
198396-3113
Approval date
2015-01-04, 1393/10/14
Ethics committee reference number
163

Health conditions studied

1

Description of health condition studied
Mental and behavioural disorders
ICD-10 code
F03
ICD-10 code description
Unspecified dementia

Primary outcomes

1

Description
Cognitive state
Timepoint
In the beginning and the end of prescription and three months following the treatment
Method of measurement
Mini Mental State Exam(folstein)

Secondary outcomes

1

Description
Side effects
Timepoint
During and three months after the treatment
Method of measurement
Symptoms and signs by the physician

Intervention groups

1

Description
Extract of Nepeta menthoides Boiss and Buhse in the form of 500 mg capsules three times in a day in the intervention group
Category
Treatment - Drugs

2

Description
Starch in the form of 500 mg caps three times a day in the control group
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Iran Alzheimer's Association
Full name of responsible person
Ali Nazeri
Street address
Ekbatan, Basij Square, North nursing the sattari exit, next to the Municipal District 6
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
School of Traditional Medicine, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mina Movahed
Street address
8, Shams Alley, Across from Shaid Abbaspour St, Vali Asr Ave
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
School of Traditional Medicine, Shahid Beheshti 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
School of Traditional Medicine, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Azam Abdolahadi
Position
Ph.D Candidated of Iranian Traditional Medicine
Other areas of specialty/work
Street address
Taleghani - St. Mousavi - a Bijan - No. 5 . 12
City
Tehran
Postal code
1583915935
Phone
+98 21 8883 7477
Fax
Email
dr.abdolahadi@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Traditional Medicine, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mina Movahed
Position
Professor of Traditional Medicine
Other areas of specialty/work
Street address
8, Shams Alley, Across from Shaid Abbaspour St, Vali Asr Ave
City
Tehran
Postal code
Phone
+98 21 8871 3521
Fax
+98 88795008
Email
sitm@sbmu.ac.ir
Web page address
http://traditional.sbmu.ac.ir/

Person responsible for updating data

Contact
Name of organization / entity
School of Traditional Medicine, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Azam Abdolahadi
Position
Ph.D Candidated of Iranian Taditional Medicine
Other areas of specialty/work
Street address
Taleqhany- Bijan St. Mvsvy- a C 5-12
City
Tehran
Postal code
1583915935
Phone
+98 21 8883 7477
Fax
Email
dr.abdolahadi@gmail.com
Web page address

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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