1) Objectives:Determination of effect of Lavender on intensity and number of monthly seizure attacks in patients with intractable epilepsy referred to neurology clinic
2) Design: Randomized interventional study, single center, phase 2 trail
3) Participants: Inclusion criteria: diagnosis of intractable epilepsy and lack of seizure control in multi-drug therapy in the past 6 months.Exclusion criteria: Having allergy to Lavender and pregnancy
4) Sample size: 40 patients in intervention and control groups
5) Intervention: The patients in intervention group will be received lavender tea bag(5 gr dried plant) twice per day in addition to routine anticonvulsant therapy. The patients in control group will be received routine anticonvulsant medication for 4 months. Patients will be visited monthly and number and intensity of seizure attacks will be recorded by questionnaire.
6) Intervention period: Four months
7) Main outcome measures: number of seizure attacks in month and its intensity
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201203142085N8
Registration date:2012-04-19, 1391/01/31
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-04-19, 1391/01/31
Registrant information
Name
Neda Parvin
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 1333 5652
Email address
nedali285@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shahrekord University of Medical Sciences
Expected recruitment start date
2010-05-01, 1389/02/11
Expected recruitment end date
2012-04-30, 1391/02/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Lavender on intensity and number of monthly seizure attacks in patients with intractable epilepsy referred to neurology clinic
Public title
Effect of Lavender on intensity and number of monthly seizure attacks in patients with intractable epilepsy referred to neurology clinic
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Diagnosis intractable epilepsy with neurologist; use at least two anti-convulsant medication; lack of seizure control in multi-drug therapy in the past 6 months and willingness to participate in the study.
Exclusion criteria: having drug sensitivity and use of other medicinal plants; use of psychotropic drugs; specific problems and drug sensitivity during treatment; have not desire for continuing treatment and pregnancy
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Shahrekord Medical university of sciences
Street address
Rahmatie,Shahrekord, Shahrekord Medical university of sciences.
City
Shahrekord
Postal code
Approval date
2010-04-24, 1389/02/04
Ethics committee reference number
89-2-4
Health conditions studied
1
Description of health condition studied
Epilepsy
ICD-10 code
G40.8
ICD-10 code description
Other epilepsy
Primary outcomes
1
Description
Number of seizure attacks in month and its intensity
Timepoint
Monthly
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The patients in intervention group will receive lavender tea bag(5 gr dried plant) twice per day in addition to routine anticonvulsant therapy for 4 months.
Category
Treatment - Drugs
2
Description
The patients in control group will receive routine anticonvulsant medication for 4 months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Neurology clinic of Shahrekord Medical university of sciences
Full name of responsible person
Nahid Jivad
Street address
Shariati Street,Neurology clinic of Shahrekord Medical university of sciences
City
Shahrekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Shahrekord university of Medical sciences
Full name of responsible person
Mahmood Mobasheri, Vice chancellor for research,Shahrekord university of Medical sciences
Street address
Rahmatie, Shahrekord, Shahrekord Medical university of sciences
City
Shahrekord
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,Shahrekord 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
Shahrekord Medical university of sciences
Full name of responsible person
Neda Parvin
Position
Faculty member
Other areas of specialty/work
Street address
Rahmatie,Shahrekord Medical University of Sciences, Shahrekord
City
Shahrekord
Postal code
Phone
+98 38 1333 5648
Fax
Email
np285@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahrekord Medical university of sciences
Full name of responsible person
Neda Parvin
Position
Faculty member
Other areas of specialty/work
Street address
Rahmatie,Shahrekord Medical University of Sciences, Shahrekord
City
shahrekord
Postal code
Phone
+98 38 1333 5648
Fax
Email
np285@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahrekord Medical university of sciences
Full name of responsible person
Neda Parvin
Position
Faculty member
Other areas of specialty/work
Street address
Rahmatie, Shahrekord Medical university of sciences, shahrekord
City
Shahrekord
Postal code
Phone
+98 38 1333 5648
Fax
Email
np285@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)