Evaluation of the effect of Medicinal Ma-alshaeir( herbal product based on Iranian traditional medicine) in comparison with placebo on clinical symptoms of patients with Chronic Idiopathic Urticaria: A randomized triple-blind clinical trial
Determining the effect of barley extract on clinical symptoms and quality of life in patients with Chronic Spontaneous Urticaria .
Design
Randomised, superiority, parallel group trial with triple blinded outcome assessment on 46 patients. Randomisation was centralised and computerised with concealed randomisation sequence carried out at an external site
Settings and conduct
Patients with Chronic Idiopatic Urticaria allergy clinic of ghaem hospital are examined by immunologist and the international urticaria registry form including demographic factors, hives severity and quality of life is completed. barley extract is prescribed for 4 weeks. the specialist will review and complete the forms after 4 week.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients of Chronic Idiopatic Urticaria between the ages of 18 and 60, having no history of autoimmune disease or immunodeficiency at present, willingness to participate in the study
Inclusion criteria: pregnancy, previous sensitivity to medication or its components
Intervention groups
Patients use barley extract for 4 weeks. The drug is dissolved in the form of 15 cc morning and evening powder in a glass of water and is whipped. Placebo is prepared in the same shape and color and consumed by the patient for 4 weeks
Main outcome variables
clinical sign & symptom by international urticaria registry form
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210309050643N1
Registration date:2021-06-28, 1400/04/07
Registration timing:registered_while_recruiting
Last update:2021-06-28, 1400/04/07
Update count:0
Registration date
2021-06-28, 1400/04/07
Registrant information
Name
Iran saeidinejat
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3884 8931
Email address
saeedish1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-22, 1400/04/01
Expected recruitment end date
2021-11-22, 1400/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Medicinal Ma-alshaeir( herbal product based on Iranian traditional medicine) in comparison with placebo on clinical symptoms of patients with Chronic Idiopathic Urticaria: A randomized triple-blind clinical trial
Public title
Evaluation of the effect of Barley extract in the treatment of chronic urticaria
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with chronic spontaneous urticaria, aged 18 to 60 years
do not have autoimmune disease or immunodeficiency
wish to participate in the study
Exclusion criteria:
pregnancy
Previous hypersensitivity to the drug or any of the compounds present in the herbal medicinal product
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method in this study will be block-randomization. each block has four numbers. The sequence produced by the https://www.sealedenvelope.com/ will be provided to the researchers by the project methodologist and will be placed in sealed, opaque, and numbered envelopes. The project researcher opens one of the envelopes when each patient enters the clinic and the patient will be assigned to the group mentioned in the envelope.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo and druge _same packaged_ marked by specified code and consumption instruction. patient and attentive and analyzer are blind ,at the end of study outcomes decode by researcher.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
School of Medicine- Mashhad University of Medical Sciences - Biomedical Research Ethics Committee
Street address
Azadi Squair- Kalantary Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Approval date
2021-02-09, 1399/11/21
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1400.099
Health conditions studied
1
Description of health condition studied
urticaria
ICD-10 code
L50
ICD-10 code description
Urticaria
Primary outcomes
1
Description
detect the effect of barley extract on clinical symptoms of CSU patients
Timepoint
At the beginning of the intervention and 4 weeks after taking the drug
Method of measurement
International Urticaria Registration Questionnaire
Secondary outcomes
1
Description
urticaria clinical symptoms score
Timepoint
At the beginning of the intervention and 4 weeks later
Method of measurement
Urticaria Activity score Questionnaire
2
Description
Quality of life of chronic urticaria patients
Timepoint
At the beginning of the intervention and 4 weeks later
Method of measurement
score of Chronic Urticaria Quality of Life questionnaire
3
Description
relapse of patients' clinical symptoms
Timepoint
At the beginning of the intervention and 4 weeks later
Method of measurement
Urticaria Control Test
Intervention groups
1
Description
Intervention group: Herbal product based on barley seeds (Hordeum vulgare) in a dose of 15 grams in 2 doses for 4 weeks is prescribed. The herbal product contains an aqueous extract of barley seeds which is converted into powder during the spray-drying process and presented to the patient.Patients also receive the common urticaria drug, Foxofenadine 180 mg twice daily.
Category
Treatment - Drugs
2
Description
Control group: Provide placebo powder 15 mg twice a day + Faxophenadine 180 mg twice a day
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Maryam Khoshkhui
Street address
School of Persian and complementary medicine, University campus, Azadi Square, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3884 8931
Email
khoshkhuim@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Deputy of Research and Technology, Gharshi Building, Daneshgah St., Mashhad, Iran.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3881 4043
Email
vcresraech@mums.ac.ir
Web page address
https://v-research.mums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Shahin Saeidinejat
Position
PhD student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
School of Persian and complementary medicine, University campus, Azadi Square, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
0098513884892
Email
Saeedish1@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Alireza Derakhshan
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
School of Persian and complementary medicine, University campus, Azadi Square, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98513884892
Email
DerakhshanAR@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Shahin Saeidinejat
Position
PhD Student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
School of Persian and complementary medicine, University campus, Azadi Square, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3884 8931
Email
saeedish1@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The data related to main outcome will be provided to the researchers upon request from corresponding author and after confirmation by him.
When the data will become available and for how long
Access starts from the time the article is published until one year later
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Access to the raw data collected in this study will be possible after obtaining permission from the lead researchers and the responsible author. Research use in the form of publishing a new article of the data in this study requires the written permission of the researchers of current study.
From where data/document is obtainable
Applicants can communicate with the person who is scientifically responsible for this research via email derakhshanar@mums.ac.ir
What processes are involved for a request to access data/document
Send the request via the mentioned email and explain the reason for the request and the applicant's details and a description of possible uses Accepting or rejecting the request from the main researcher of the research by email