Effect of achillea supplement on disability, quality of life and performance of patients with ischemic stroke
Design
A clinical trial with a control group and an intervention group, three blind, randomized, phase 3 on 110 patients. Web-based software is used for randomization.
Settings and conduct
Eligible stroke patients referred to the emergency room of Ali Ibn Abi Talib Hospital with full consent were included in the study and randomly divided into two groups of 55 people, intervention and placebo.
The routine treatment of patients by the doctor during the period of taking the supplement goes through its normal process. Our treatment continues for three months, one capsule daily.
The tests are done before and after the intervention (3 months later).
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age above 18 years
Informed consent of the patient or relatives 1st degree
Have had an ischemic stroke for the first time
do not have NIHSS above twenty-five.
ability to swallow
Exclusion criteria:
Use of Alteplase in treatment
Patients with skin allergies
Patients who are pregnant or plan to become pregnant or decide to breastfeed.
Intervention groups
The first group = capsules containing 500 mg of water yarrow extract. The second group = receive placebo capsules containing cellulose.
Main outcome variables
NIHSS = score of disability in stroke patients (0-42) before and after the intervention, mRs = a functionals score for stroke patients (0-6) before and after the intervention, Stroke Specific quality of life before and after the intervention
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190129042540N2
Registration date:2023-04-26, 1402/02/06
Registration timing:registered_while_recruiting
Last update:2023-04-26, 1402/02/06
Update count:0
Registration date
2023-04-26, 1402/02/06
Registrant information
Name
Alireza Vakilian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3428 9393
Email address
alirezavakilian66@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-21, 1402/02/01
Expected recruitment end date
2024-04-20, 1403/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of achillea millefolium on disability and functional state of ischemic stroke patients, A clinical trial study
Public title
Effect of achillea Mellifolium in Ischemic Stroke
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
ischemic stroke for the first time
satisfy to participate
nihss less than 25
age more than 18
Exclusion criteria:
The use of alteplase in treatment
impaired swallowing
pregnancy or intend to be pregnant
using other herbal medicine
allergy to achillea millefolium
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was done using free web-based systems.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Participants do not know which drug is placebo and which is the main drug.
The follower of drug prescription and the examiner of the results of function and quality of life are unaware of the type of drug.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Rafsanjan University of Medical Sciences Ethics committee
Street address
Imam Ali boulevard
City
Rafsanjan
Province
Kerman
Postal code
7717937555
Approval date
2022-12-06, 1401/09/15
Ethics committee reference number
IR.RUMS.REC.1401.206
Health conditions studied
1
Description of health condition studied
Ischemic stroke
ICD-10 code
I63
ICD-10 code description
Cerebral infarction
Primary outcomes
1
Description
disability scale
Timepoint
First and 3 months later
Method of measurement
Questionnaire of NIHS
Secondary outcomes
1
Description
functional state
Timepoint
First and 3 months later
Method of measurement
Questionnaire of Modified Rankin Scale (mRS)
Intervention groups
1
Description
Treatment group: Stroke patients are randomly assigned to the treatment group. People in this group receive yarrow capsules. Capsules in a dose of 500 mg are prepared from the aqueous extract of flowering branches and yarrow leaves. First, the plant is purchased from the Isfahan herbarium after the herbarium expert confirms the species. Then it is cleaned, thoroughly washed, and dried in a cool and dark place. The capsules are extracted and prepared at Barich Essence pharmaceutical company (4 grams of plant powder is brewed in 200 ml of distilled water for 20 minutes and then the extract is separated and dried). Patients take one capsule daily, preferably with food, for 3 months. Achillea extract has anti-inflammatory and neuroprotective properties due to the presence of apigenin and luteolin and improves CNS function. So far, the effects of this medicinal plant have been studied on MS and several other inflammatory diseases , but it has not been studied on stroke.
Category
Treatment - Drugs
2
Description
Control group: Control group: The other group of cerebral ischemia stroke patients randomly use cellulose capsules made by Barij Essan company with the same shape and weight as the drug for three months.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali-Ibn-Abitalib Hospital
Full name of responsible person
Alireza Vakilian
Street address
No 13. 4th Alley,Emam Ave.
City
Rafsnajan
Province
Kerman
Postal code
7717653995
Phone
+98 34 3428 9393
Email
alirezavakilkian7@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Reza Vazirinejad
Street address
Central Organization, Imam Ali Boulevard, Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0038
Email
info@rums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Alireza Vakilian
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
13,4th Alley, Emam Avenue
City
Rafsanjan
Province
Kerman
Postal code
7717937555
Phone
+98 34 3428 9393
Email
alirezavakilian66@rums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Alireza Vakilian
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
13,4th Alley, Emam Avenue
City
Rafsanjan
Province
Kerman
Postal code
7717937555
Phone
+98 34 3428 9393
Email
alirezavakilian66@rums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Alireza Vakilian
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
13,4th Alley, Emam Avenue
City
Rafsanjan
Province
Kerman
Postal code
7717937555
Phone
+98 34 3428 9393
Email
alirezavakilian66@rums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All the data obtained in the study will be made available to the public after being de-identified through the writing of the article.
When the data will become available and for how long
The data will be published after the conclusion of the research plan and the statistical analysis of the findings and the preparation of the results in about two years.
To whom data/document is available
The data does not belong to specific people and the results are available to the public.
Under which criteria data/document could be used
There is no special condition for using the data and the public can use the results.
From where data/document is obtainable
The data will be published as an article, and if needed, it will be available through correspondence with the corresponding author's email.
What processes are involved for a request to access data/document
The applicant can contact the corresponding author via email and send a request for access to the results