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The effect of locally administered Sambucus ebulus gel 5% on the severity and extention of pruritus in hemodialysis patients

Protocol summary

Study aim
Comparison of the effect of topical gel containing Sambucus ebolus extract compared with placebo on reducing itching complications in hemodialysis patients
Design
A randomized, controlled, single-blind, placebo-controlled clinical trial
Settings and conduct
A randomized, controlled, single -blind, placebo-controlled clinical trial The person evaluating the severity of the itch is unaware of the product The dialysis centers of the citizens of Sari and Imam Reza Amol are performed.The sample size is 150 patients.The person evaluating the severity of the itch is unaware of the product.Due to the special color and smell of herbal products, it is not possible to blind the patient.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Patients over 18 years who have been undergoing hemodialysis for more than 3 months, Patients who have had itching at least 3 times in the last 2 weeks, Despite drug use in the last month of treatment, no evidence of improvement was observed, Patients undergo hemodialysis 3 days a week for 3–5 hours per session, Have no skin problems other than uremic itching, Patients who gave their written consent to participate in the project, Patients who do not use another method to reduce their severity, Lack of systemic diseases such as liver cholestatic, hepatitis B, HIV thyroid disorders and women who are not pregnant and breastfeeding, Lack of cognitive impairments that cannot answer questions, Exclusion criteria: If the patient undergoes kidney transplantation during the study, If allergic to sambucus ebulus gel, Patients who do not wish to continue the study for personal reasons, Patients suffering from P tests above 6 and PTH more than 300
Intervention groups
Group A: sambucus ebulus gel, Group B: Placebo gel, Group C: Control (without intervention)
Main outcome variables
pruritus

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191231045958N1
Registration date: 2020-04-12, 1399/01/24
Registration timing: prospective

Last update: 2020-04-12, 1399/01/24
Update count: 0
Registration date
2020-04-12, 1399/01/24
Registrant information
Name
Mohadese Saberian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 4466 9545
Email address
h_saberian@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-20, 1399/02/01
Expected recruitment end date
2020-06-21, 1399/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of locally administered Sambucus ebulus gel 5% on the severity and extention of pruritus in hemodialysis patients
Public title
The effect of locally administered Sambucus ebulus gel 5% on the severity and extention of pruritus in hemodialysis patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients over 18 years who have been undergoing hemodialysis for more than 3 months Patients who have had itching at least 3 times in the last 2 weeks Despite drug use in the last month of treatment, no evidence of improvement was observed Patients undergo hemodialysis 3 days a week for 3–5 hours per session Have no skin problems other than uremic itching Patients who gave their written consent to participate in the project Patients who do not use another method to reduce the severity of itching Lack of systemic diseases such as liver cholestatic, hepatitis B, HIV thyroid disorders and women who are not pregnant and breastfeeding Lack of cognitive impairments that cannot answer questions
Exclusion criteria:
If the patient undergoes kidney transplantation during the study If there is allergy to sambucus ebulus gel Patients who do not wish to continue the study for personal reasons Patients with a phosphorus test range of more than 6 and a PTH of more than 300
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 150
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomly assigned to each group using Permuted block Randomization as follows. We select 25 blocks of 6. The blocks will be from 120 different modes such as AABBCC, AABCBC, AACBCB, ABCABC, BABCAC, ACBBCA. In each block there will be two cases of group A and two cases of group B and two cases of group C. The computer program selects one randomly each time and the order of people in the groups is random.
Blinding (investigator's opinion)
Single blinded
Blinding description
The person evaluating the severity of the itch is an unaware product
Placebo
Used
Assignment
Parallel
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
Moalem Square
City
Sari
Province
Mazandaran
Postal code
48175886
Approval date
2020-03-11, 1398/12/21
Ethics committee reference number
IR.MAZUMS..REC.1398.6082

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
first visit-The fourth and eighth week after starting to use the gel.
Method of measurement
48-point scale for itching severity

Secondary outcomes

1

Description
skin dryness
Timepoint
first week, The fourth and eighth week after starting to use the gel.
Method of measurement
Examination

Intervention groups

1

Description
The aim of this study was to investigate the effect of locally administered sambucus ebulus gel 5% on the severity and extention of pruritus hemodialysis patients.Three groups of patients are examined, in each group there are 50 hemodialysis patients. The first group uses sambucus ebulus 5% gel - the second group uses placebo gel and the third group is without intervention. sambucus ebulus gel prepared in the laboratory of Mazandaran University of Medical Sciences .After preparing the gel, Patients in both the intervention and placebo groups are taught to use the gel twice a day, morning and night, for 8 weeks.So as to cover the itchy area.Intervention group: Topical product containing 5% sambucus ebulus extract, twice daily for two months
Category
Treatment - Drugs

2

Description
Control group: placebo gel. Fifty hemodialysis patients who are randomly assigned to this group use placebo gel prepared at the Faculty of Pharmacy, Mazandaran University. These patients are also taught to use the gel twice a day, morning and night, at home for 8 weeks to cover the itchy area.
Category
Placebo

3

Description
Without intervention-This group was considered for the psychological dimension of drug use in patients with severe itching.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza (AS) Amol City Hospital
Full name of responsible person
hedayat jafari
Street address
Imam Reza Boulevard
City
Amol
Province
Mazandaran
Postal code
۳۷۵۹۷-۴۶۱۴۹
Phone
+98 11 4327 4013
Email
hedayat2003@yahoo.com

2

Recruitment center
Name of recruitment center
Shahrvand
Full name of responsible person
Hedayat jafari
Street address
Keshavarz Boulevard
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3329 1897
Email
hedayat2003@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
hedayat jafari
Street address
Imam Khomeini Square - Joibar Three Ways
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3304 4000
Email
hedayat2003@yaho.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
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
mohadese saberian
Position
University student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Vesal street
City
Sari
Province
Mazandaran
Postal code
۴۸۱۶۷۱۵۷۹۳
Phone
۳۳۳۶۷۳۴۲
Email
h_saberian@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Hedayat jafari
Position
assistant profesor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Vesal street
City
Sari
Province
Mazandaran
Postal code
۴۸۱۶۷۱۵۷۹۳
Phone
۳۳۳۶۷۳۴۲
Email
Hedayat2003@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
mohadese saberian
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Vesal street
City
Sari
Province
Mazandaran
Postal code
۴۸۱۶۷۱۵۷۹۳
Phone
۳۳۳۶۷۳۴۲
Email
h_saberian@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
Patient data - Demographic information and itching score at each stage in each group
When the data will become available and for how long
Data will be available after the study and statistical analysis.
To whom data/document is available
There is no limit.
Under which criteria data/document could be used
In order to conduct similar studies
From where data/document is obtainable
Dr.Hedayat jafari
What processes are involved for a request to access data/document
0
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