The purpose of the study:
Compare the intensity of the tremor in multiple sclerosis patients receiving Iranian Laveder with placebo.
Study design:
Randomized, double-blind, placebo-controlled, single-center, phase two trials.
The method of study:
- Study population:Proven MS patients in the age range 15 to 50 years registered in the Khuzestan MS Community without no Allergy to lavender and any other serious and chronic disease(exeption MS), and no pregnancy or breastfeeding in women.
-Sample size:Due to lack of proper estimation of the possible effect of the drug on the results of previous similar studies,the sample size will be determined based on the results of a pilot study.
-Intervention study:The study was a randomized controlled clinical trial, patients are devided randomized in to two groups, receiving Lavender or placebo (both medication form and taste are simillar).Each group receives placebo or medication for eight(8) weeks.Immediately before the intervention and after the end of the eighth week,Patients will be evaluated in terms of changes in tremor severity with two types of questionnaire(The tremor part of the MDS-UPDRS questionnaire) and also by the tremor detector (Motion Capture System).
-Intervention time:8(eight) weeks
-The primary outcome of the study:Finally, by comparing the changes as well as changes in questionnaire and tremor amplitude that would be reported by Motion Capture System (Analysis is based on the tremor research group scale), we will be judged on the effectiveness of the drug and placebo.
The study of the effectivness of iranian lavender on tremor of Multipl Sclerosis patients: (Randomized controlled trial)
Public title
The effect of Lavender planet in the treatment on tremor of Multipl Sclerosis patients.
Purpose
Treatment
Inclusion/Exclusion criteria
Including criteria:
1:Having proven MS according to the clinical examination and medical history
2:EDSS rating between 2 to 5.5
3:Having constant and regular medical treatment in the past 4 weeks
4:Consent to use of alternative medicines 7 days before the start of intervention to the end of intervention
5:Not be in another study at the same time
6:Age 15 to 50 years
Excluding criteria:
1:History of alcohol or drug dependence
2:pregnancy or Breastfeeding
3:Impaired renal and/or liver function
4:Treatment with steroids over a month before the start of the study
5:Having a neurological disease in addition to multiple sclerosis
6: Having Cardiovascular or Lung disease( such as Asthma) or Diabetes
7:Allergy to Lavender
Age
From 15 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Blocked randomization
Secondary Ids
1
Registry name
_
Secondary trial Id
_
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur Univercity of Medical Siences
Street address
Ahvaz jundishapur Univercity of Medical Siences,Golestan quarter,Ahvaz
City
Ahvaz
Postal code
Approval date
2016-04-28, 1395/02/09
Ethics committee reference number
IR.AJUMS.REC.1395.50
Health conditions studied
1
Description of health condition studied
Multiple Sclerosis
ICD-10 code
G00-G99
ICD-10 code description
G35
Primary outcomes
1
Description
Tremor
Timepoint
Questionnair :before the intervention, after four weeks of intervention and after the intervention / Tremor measuring machine: before the intervention and after the intervention
Method of measurement
Questionnair:Tremor part from MDS-UDPRS/ Tremor measuring machine(Motion Capture System)
Secondary outcomes
1
Description
Drug Side effects
Timepoint
Four weeks after the intervention, after intervention
Method of measurement
Oral questions from patients
Intervention groups
1
Description
Control group: placebo, oral capsule, Once a day for 8 weeks, made by Barijessence Pharmaceutical Factory
Category
Placebo
2
Description
Intervention group:
Iranian Lavender oil, 80 mg oral capsule, Once a day for 8 weeks, made by Barijessence Pharmaceutical Factory
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan Hospital
Full name of responsible person
Golakeh Karimi, Neurology Resident, Medical Student