The aim of this clinical study is to compare the effect of Sambucus ebolus extract topical preparation and placebo, on psoriasis skin disorders. (This plant is native at the north of Iran and has been used in traditional medicine as analgesic and anti-inflammatory, and high anti-oxidant activity). The patients who are suffering from psoriasis 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 patients with psoriasis skin disorder (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
Effect of Palem on psoriasis
IRCT registration information
IRCT registration number:IRCT2017072210203N8
Registration date:2017-07-24, 1396/05/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-07-24, 1396/05/02
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
2016-06-21, 1395/04/01
Expected recruitment end date
2017-08-23, 1396/06/01
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 skin disorders in psoriasis patients, a clinical trial
Public title
Evaluation of Palem topical preparation on psoriasis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria: Patients with psoriasis during 3 months, at the age of 13 years and more; 3 times pruritus during last two weeks before study; or receive treatment during one month without any significant response. Exclusion criteria: pregnancy and breast feeding; sensitivity to topical preparation.
Age
From 13 years old to 70 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)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Every patient allocates one code based on random number table, and receives drug or placebo.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Moallem square
City
Sari
Postal code
Approval date
2017-02-28, 1395/12/10
Ethics committee reference number
IR.MAZUMS.REC.95.2599
Health conditions studied
1
Description of health condition studied
Psoriasis
ICD-10 code
L40.1
ICD-10 code description
Generalized pustular psoriasis
Primary outcomes
1
Description
PASI Score
Timepoint
Time zero and after 4 and 8 weeks
Method of measurement
Based on area (head, trunk, arms, legs) and erythema, induration and scaling by physical examination.
Secondary outcomes
1
Description
Pruritus
Timepoint
time zero, and after 4 and 8 weeks
Method of measurement
qualitative questioner (0 to 4)
Intervention groups
1
Description
Intervention group: Sambucus ebulus topical preparation 2% (ointment) formulated in Sari"s faculty of pharmacy, two times a day for two months
Category
Treatment - Drugs
2
Description
Control group: Placebo (ointment without extract), two times a day for two months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Boo Ali hospital
Full name of responsible person
Majid Saeedi
Street address
Pasdaran Blvd.
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 square
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
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, Prof.
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)