Trial comparison of the effect of cutaneous lipogels containing Jujube and Echium amoenum plant extracts with placebo on the severity of pruritus in hemodialysis patients.
Determining the effect of cutaneous lipogels containing jujube and Echium extracts in comparison with placebo on the severity of pruritus in hemodialysis patients
Design
Phase 3 randomized double-blind crossover clinical trial on 50 patients. Randomization Blocked permutation method was used for randomization and there will be 8 blocks of size 6 and one block of size 2.
Settings and conduct
This study is double-blind in which the researcher who evaluates the pruritus and also the patients do not know the content of the drug tube and only the pharmacist knows the content of the tube. Place of study: Sari Shahrvand dialysis center and dialysis ward of Sari Fatemeh Zahra hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Hemodialysis patients over 18 years of age who undergo dialysis twice a week; Moderate to severe pruritus according to the Jusipovich ISS pruritus questionnaire in the last two weeks; parathyroid hormone less than 300 and phosphorus less than 6.
Non-inclusion criteria: presence of wound; Generalized limb edema (more than one plus (+1); allergy or sensitivity while working; pregnancy; breastfeeding
Intervention groups
Intervention group: Drug group (lipogel containing jujube and borage extracts).
Control group: placebo group (lipogel without drug extract)
Main outcome variables
pruritus severity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110906007494N33
Registration date:2020-09-15, 1399/06/25
Registration timing:prospective
Last update:2020-09-15, 1399/06/25
Update count:0
Registration date
2020-09-15, 1399/06/25
Registrant information
Name
Masoumeh Bagheri Nesami
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 7551
Email address
mbagheri@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-11, 1399/07/20
Expected recruitment end date
2020-12-25, 1399/10/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Trial comparison of the effect of cutaneous lipogels containing Jujube and Echium amoenum plant extracts with placebo on the severity of pruritus in hemodialysis patients.
Public title
The Effect of topical lipogel containing herbal extracts of Ziziphus jujuba and Echium amoenum on pruritus severity in hemodialysis patient
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Hemodialysis patients aged 18 years and older
End-stage renal disease undergoing regular dialysis treatment at least two or three times a week for six months
Having itching in the last two weeks and having an itching intensity score using the Usipovich Itching Intensity Scale (ISS) in the range of severe and moderate pruritus
Full alertness and ability to communicate
Parathyroid hormone (PTH), <300
Phosphor(P) <6
Exclusion criteria:
Existence of wounds in the limbs
Generalized limb edema (more than one plus (+1)
Pregnancy
Breastfeeding
Other chronic diseases and cancer
Taking other topical medications and antihistamines
History of any allergies (skin, especially to plant compounds)
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible patients will be randomly divided into two groups, group A and group B, using random number generation and computer software. With the computer program, the Randomization Blocked permuation method is applied and random blocks will be selected so that we will have 8 blocks of size 6 and one block of size 2. The patient number will be recorded on the medicine can.
Blinding (investigator's opinion)
Double blinded
Blinding description
The researcher who evaluates the pruritus and also the patients do not know the contents of the medicine cans, only the pharmacist knows the contents of the cans.
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical Sciences
Street address
Vice chancellor for research, No 2 building, Mazandran University of Medical Sciences, Moalem street, Moalem square
City
Sari
Province
Mazandaran
Postal code
4816715793
Approval date
2020-07-21, 1399/04/31
Ethics committee reference number
IR.MAZUMS.REC.1399.474
Health conditions studied
1
Description of health condition studied
Pruritus in hemodialysis patients
ICD-10 code
L29.9
ICD-10 code description
Pruritus, unspecified
Primary outcomes
1
Description
Pruritus
Timepoint
The first visit; the first, second, third and fourth weeks after starting to use lipogels.
Method of measurement
Itching 48-point scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Due to the fact that the study is a cross-over method, there are 25 people in each group. A group of 25 people with jujube and Echium amoenum lipogel will be replaced with a lipogel and placebo group after a two-week wash out period. Patients by unit FTU (one (FTU) is equal to the index finger to the first finger joint, lipogel removed from the tube with a diameter of 0.5 cm depending on the level of itching twice a day (morning (9 am) - night) 9 nights) so that a thin layer of lipogel is rubbed and spread on the itchy area of the body for one minute and the amount of medicine used on each part of the body is recorded based on the fingerprint scale. The drug is stopped for two weeks for washout.
Category
Treatment - Drugs
2
Description
Control group: Patients who received placebo in the first stage of the drug (Ziziphus jujuba and Echium amoenum ) and the group who received the drug are given placebo and again patients in terms of severity of pruritus, distribution of pruritus and drug side effects for one week and up to four per week The following week, they are examined during a telephone call with patients.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemeh Zahra Hospital, Sari
Full name of responsible person
Azam faraji
Street address
Mazandaran University of Medical Sciences; Juibar tree way
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3565 2616
Fax
Email
Az_faraji200@yahoo.com
Web page address
2
Recruitment center
Name of recruitment center
Shahrvand center; Sari
Full name of responsible person
Azam faraji
Street address
Mazandaran University of Medical Sciences; Juibar tree way
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3565 2616
Email
Az_faraji200@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr.Majid Saeedi
Street address
Mazandaran University of Medical Sciences; Joybar threeway; Valiyeasr highway; Imam square
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3565 2616
Email
az_faraji200@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Dr.Masoumeh Bagheri Nesami
Position
PhD. Nursing Education
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Vice chancellor for research, No 2 building, Mazandran University of Medical Sciences, Moalem street, Moalem square
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3565 2616
Email
az_faraji200@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Masoume Bagheri Nesami
Position
Nursing ph.D
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Mazandaran University of Medical Sciences, Basij highway, Joibar three way, Imam square
City
Sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3565 2616
Email
az_faraji200@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr.Masoumeh Bagheri Nesami
Position
ph.D. Nursing Education
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Research Assistant of Mazandaran University of Medical Sciences
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3565 2008
Email
az_faraji200@yahoo.com
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
no more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available