The aim of this clinical study is to compare the effect of Sambucus ebolus extract topical preparation and placebo, on hyper uremic pruritus. The patients who are suffering from severe pruritus due to renal failure are included in this study. Thirty patients in intervention group will receive Sambucus ebolus topical preparation and the 30 patients in the control group will receive placebo. Patients are randomly allocated to the intervention and control group. Randomization will be performed using random number table. The prescriber and evaluator will be blind during the study. The study will be done in one center. All of the renal failure patients with hyper uremic pruritus (men or women) will be included in this study and every one with sensitivity to topical preparation will be excluded. The patients will receive topical preparation (Sambucus ebulus topical preparation or placebo) twice a day for two months and the pruritus severity index and other symptoms such as dryness and ulceration due to scratching will be recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016102810203N7
Registration date:2017-03-16, 1395/12/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-03-16, 1395/12/26
Registrant information
Name
Majid Saeedi
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1354 3082
Email address
msaeedi@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mazandaran University of Medical Sciences
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2016-12-21, 1395/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Sambucus ebulus topical preparation and placebo, on pruritus in hyperuremic patients, a clinical trial
Public title
Evaluation of Palem topical preparation on hemodialysis pruritus
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria: Patients with hemodialysis during 3 months, or chronic renal failure with hyperuremia; at the age of 18 years and more; 3 times pruritus during last two weeks before study; dry skin without edema. Exclusion criteria: Other diseases like liver failure and heart disease; pregnancy and breast feeding; sensitivity to topical preparation.
Age
From 18 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Random numbers table
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Moallem sq.
City
Sari
Postal code
Approval date
2015-11-21, 1394/08/30
Ethics committee reference number
IR.MAZUMS.REC.94-1785
Health conditions studied
1
Description of health condition studied
hyperuremic pruritus
ICD-10 code
L29.9
ICD-10 code description
Pruritus, unspecified
Primary outcomes
1
Description
Pruritus severity
Timepoint
Baseline, 4th and 8th week
Method of measurement
Pruritus severity scale (48 scores)
Secondary outcomes
1
Description
Skin Xerosis
Timepoint
Baseline, 4th and 8th weeks
Method of measurement
observation
Intervention groups
1
Description
Control group: Placebo, two times a day for two months
Category
Placebo
2
Description
Intervention group: Sambucus ebulus topical preparation 2% , two times a day for two months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Boo Ali hospital
Full name of responsible person
Majid Saeedi
Street address
Pasdaran Blvd, Sari
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Mazandaran University of Medical Sciences
Full name of responsible person
Prof. Ahmad Ali Enayati
Street address
Moallem Sq.
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Mazandaran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Majid Saeedi
Position
Pharmaceutics, Professor
Other areas of specialty/work
Street address
Payambar Azam complex, 18th km of Khazar road
City
Sari
Postal code
Phone
+98 11 3354 3082
Fax
Email
majsaeedi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Majid Saeedi
Position
Pharmaceutics, Professor
Other areas of specialty/work
Street address
18th. km of Khazar road
City
Sari
Postal code
Phone
+98 11 3354 3082
Fax
Email
majsaeedi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Majid Saeedi
Position
Pharmaceutics, Professor
Other areas of specialty/work
Street address
18th. km of Khazar road
City
Sari
Postal code
Phone
+98 11 3354 3082
Fax
Email
majsaeedi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)