The effect of lavender extract hydroalcoholic extract on ataxia and spasm in patients with multiple sclerosis.
Design
This clinical trial randomized with software; single blind in which 84 patients with multiple sceloresis with inclusion criteria divided into two groups of intervention and control.
Settings and conduct
This study is performed on referrer to Kashani and Hajar hospitals in Shahrekord in single blind. the patient chooses one of the two drugs randomly and the name of each person and the code of the drug provided to him by the secretary is registered and neither the patient nor the researcher has any information about the type of medication. And only when analyzing the data will the names of each individual and his drug be identified to complete the information profile of the patients by mentioning the name of the drug received by them. In that tester, they do not know the type of drug received. The intervention group received one herbal tea (manufactured by Kohgel Company) and the control group received one placebo tea for 60 days daily.
Participants/Inclusion and exclusion criteria
Age between 20 and 50 years, diagnosis of MS, obtaining a score of 3-5 in disability severity scale (EDSS), and stable spasticity with the score ≥2 for one of the joints on the Ashworth scale. Also, the presence of ataxia, lack of neurological deficits (other than MS), cardiovascular disease, infectious diseases, and lack of exacerbation of clinical symptoms of MS. eclusion criteria: dissatisfaction with cooperation, drug sensitivity and drug use other than prescribed medications
Intervention groups
The intervention group received one herbal tea (manufactured by Kohgel Company) and the control group received one placebo tea for 60 days daily.
Main outcome variables
ataxia, spasm
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220818055740N1
Registration date:2022-09-11, 1401/06/20
Registration timing:retrospective
Last update:2022-09-11, 1401/06/20
Update count:0
Registration date
2022-09-11, 1401/06/20
Registrant information
Name
Nahid Jivad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3335 1031
Email address
jivad@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-14, 1398/04/23
Expected recruitment end date
2019-09-14, 1398/06/23
Actual recruitment start date
2019-07-14, 1398/04/23
Actual recruitment end date
2019-09-14, 1398/06/23
Trial completion date
2022-09-11, 1401/06/20
Scientific title
The effect of lavender tea on the ataxia and spasm in patients with multiple sclerosis
Public title
The effect of lavender tea on the ataxia and spasm in patients with multiple sclerosis
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria: age between 20 and 50 years, diagnosis of MS disease, scoring 3-5 on the Disability Severity Scale (EDSS), and the presence of stable spasticity with a score of ≥ 2 for one of the joints on the Ashurt scale, the presence of ataxia, and the absence of neurological defects.(other than MS), cardiovascular, infectious diseases, no exacerbation of clinical symptoms of MS, no treatment with steroids two months before entering the study.
Exclusion criteria:
Exclusion criteria: dissatisfaction to cooperation, sensitivity to drugs and consumption of drugs other than prescribed drugs.
Age
From 20 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
84
Actual sample size reached:
84
Randomization (investigator's opinion)
Randomized
Randomization description
The random allocation of the participants to the intervention and control groups will be done using random allocation software. Then, some envelopes will be prepared according to the number of participants in the study. Then number 1 will be recorded on the first envelope, number 2 on the second envelope, and etc. The sequence of assignment of the participants will be determined by the software and each assignment will be put inside each envelope respectively. At the time of study , the specified envelope for each individual will be opened and the individual will be assigned to one of the intervention and control groups according to the option recorded inside the envelope.
Blinding (investigator's opinion)
Single blinded
Blinding description
The single blindness of the study was that the mentioned drugs received code without any labels and the patient selected one of the two drugs randomly. Then, the name of each person and the drug code provided to him registered by the secretary. Neither the patient nor the doctor knew the type of medication, and only when analyzing the data, the names of each person and his drug were specified and completed the patients' information profile by mentioning the name of the drug received by them.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahrekord University of Medical Sciences
Street address
Kashani Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8818718791
Approval date
2020-07-22, 1399/05/01
Ethics committee reference number
IR.SKUMS.REC.1398.078
Health conditions studied
1
Description of health condition studied
Multiple sclerosis
ICD-10 code
G90-G99
ICD-10 code description
G90-G99
Primary outcomes
1
Description
multiple sclerosis
Timepoint
One month after intervention
Method of measurement
Spasticity was measured based on Ashworth scale and Spasm Repetition scale. Also, ataxy was measured by Ataxi rating scale (ICARS) and Leaf BalanceTest (BSS).
Secondary outcomes
1
Description
Multiple sclerosis
Timepoint
One month after intervention
Method of measurement
Spasticity was measured based on Ashworth scale and Spasm Repetition scale. Also, ataxy was measured by Ataxi rating scale (ICARS) and Leaf BalanceTest (BSS).
Intervention groups
1
Description
Intervention group: Patients received lavender teain the intervention group for two months daily (Manufactured by Kogel Co.)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani Hospital Shahrekord
Full name of responsible person
Nahid Jivad
Street address
Kashani Hospital, Shahrekord University of Medical Sciences, Parastar Street, Shahrekord, Iran
City
Shahre kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8818718791
Phone
+98 38 3222 0016
Email
jivad@skums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr Esfandiyar heydarian
Street address
Kashani Hospital of Shahrekord University of Medical Sciences,
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8818718791
Phone
+98 38 3222 0016
Email
sadeghi.m@skums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Nahid Jivad
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Kashani Hospital of Shahrekord University of Medical Sciences, Parastar Street, Shahrekord, Iran
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8818718791
Phone
+98 38 3222 0016
Email
jivad@skums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Nahid Jivad
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Kashani Hospital of Shahrekord University of Medical Sciences, Parastar Street, Shahrekord, Iran
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8818718791
Phone
+98 38 3222 0016
Email
jivad@skums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Nahid Jivad
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Kashani Hospital of Shahrekord University of Medical Sciences, Parastar street, Shahrekord, Iran
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
818718791
Phone
+98 38 3335 1031
Email
jivad@skums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD