Determination of the effect of Jujube extract syrup (jujube and violet) on atopic dermatitis
Design
Randomized, parallel clinical trial with control group, Double blinded, phase 3 on 40 patients. Excel software rand function was used for randomization.
Settings and conduct
The samples are selected from atopic dermatitis patients referred to Afzalipur Hospital in Kerman. DLQI and SCORAD questionnaires are completed for patients. Medicine or placebo is added to the main medicine of selected patients by a dermatologist for 3 weeks. The study will be conducted in 5 weeks and the patients will be followed up 2 weeks after finishing the medicine. Patients, physician allocating samples to groups, and data analyst are blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients with atopic dermatitis over 18 years of age, no concomitant skin disease, no immune disorder and cancer, and a SCORAD score of less than 50
Exclusion criteria: Patients with a history of sensitivity to jujube or violets, the need to take systemic corticosteroids by the patient and the patient's non-compliance with the treatment protocol of using the drug
Intervention groups
Syrup of jujube and violet extracts are added twice a day, 7 ml each time for 3 weeks, to the common treatments of patients. The control group also receives sucralose artificial sugar syrup with the same color and consistency as the patients in the intervention group.
Main outcome variables
Clinical symptoms of patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231118060097N1
Registration date:2024-07-07, 1403/04/17
Registration timing:prospective
Last update:2024-07-07, 1403/04/17
Update count:0
Registration date
2024-07-07, 1403/04/17
Registrant information
Name
Maryam MehrSharif
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3270 8706
Email address
marysharif00@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-08-22, 1403/06/01
Expected recruitment end date
2025-08-23, 1404/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of a Jujube extract syrup on mild to moderate atopic dermatitis in adult patients
Public title
The effect of the Jujube syrup on mild atopic dermatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with atopic dermatitis based on physical examination and confirmation by a dermatologist
Absence of pregnancy and breastfeeding
Age 18 and above
Not having associated skin diseases
Not having diseases such as immune disorders and cancer
SCORAD less than 50
Exclusion criteria:
History of allergy to Jujube or Viola
Consumption of systemic corticosteroid by the patient
Failure to comply with the treatment protocol of drug use by the patient
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
40
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)
Double 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
Ethics committee School of Medicine Mashhad University of Medical Sciences
Street address
Kalantary Street, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Approval date
2024-05-11, 1403/02/22
Ethics committee reference number
IR.MUMS.REC.1403.080
Health conditions studied
1
Description of health condition studied
Atopic Dermatitis
ICD-10 code
L20
ICD-10 code description
A chronic inflammatory genetically determined disease of the skin marked by increased ability to form reagin, with increased susceptibility to allergic rhinitis and asthma, and hereditary disposition to a lowered threshold for pruritus.
Primary outcomes
1
Description
Redness and erythema
Timepoint
0, 3, 5 weeks
Method of measurement
SCORAD questionnaire
2
Description
Dryness
Timepoint
0, 3, 5 weeks
Method of measurement
SCORAD questionnaire
3
Description
Excoriation
Timepoint
0, 3, 5 weeks
Method of measurement
SCORAD questionnaire
4
Description
Itching
Timepoint
0, 3, 5 weeks
Method of measurement
SCORAD questionnaire
Secondary outcomes
1
Description
Quality of life
Timepoint
0, 3, 5 weeks
Method of measurement
DLQI questionnaire
Intervention groups
1
Description
Intervention group: Patients receive 14 ml of Jujube extract syrup, including aqueous extract of jujube, and viola odorata, divided into two parts in the morning and evening for 3 weeks. This syrup is formulated and produced under standard conditions by the research team in the pharmaceutical laboratory of the School of Persian and Complementary Medicine of Mashhad University of Medical Sciences.
Category
Treatment - Drugs
2
Description
Control group: Patients receive 14 ml of placebo syrup containing artificial height sucralose, divided into two parts in the morning and evening for 3 weeks. This syrup is formulated and produced under standard conditions by the research team in the pharmaceutical laboratory of the School of Persian and Complementary Medicine of Mashhad University of Medical Sciences.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dermatology clinic of Afzalipoor hospital
Full name of responsible person
Dr Saeedeh Farajzadeh
Street address
Afzalipoor Medical Education Center (next to Shahid Bahonar University), Afzalipoor Campus, Imam Highway
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
+98 34 3132 8000
Email
safaderm@yahoo.com
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, Ghoreishi 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
Maryam Mehrsharif
Position
PhD students
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Traditional and Complementary Medicine, Kharazmi Complex, University Campus, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3884 8931
Email
Marysharif00@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Sadegh Shokri
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Traditional and Complementary Medicine, Kharazmi Complex, University Campus, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3884 8931
Email
shokris@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Maryam Mehrsharif
Position
PhD students
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Traditional and Complementary Medicine, Kharazmi Complex, University Campus, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3884 8931
Email
Marysharif00@gmail.com
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
After the end of the study, the results will be published in the form of an original paper in an international journal and will be available to other researchers. Access to raw data collected in this study will be possible after obtaining permission from the original researchers and the corresponding author. Using the data of this project to carry out research or publish a new article requires written permission from the person responsible for scientific inquiries in this research.
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 raw data collected in this study will be possible after obtaining permission from the original researchers and the corresponding author. Using the data of this project to carry out research or publish a new article requires written permission from the person responsible for scientific inquiries in this research.
From where data/document is obtainable
Applicants can communicate with the person who is scientifically responsible for this research via email.
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.