Assessment of the effects of oral whey protein (an Iranian Traditional Medicine product) on improvement of mild to moderate skin lesion of psoriasis in comparison with placebo
The aim of this study is to evaluate the effect of whey protein on improvement of mild to moderate skin lesions on psoriasis sufferers. This study is a randomize / phase 2/ triple- blind clinical trial.The important criteria :The patients having under 10 percent of skin lesion؛ The patients suffering from stable plaque psoriasis .The criteria that impede patients from entering the study : allergy to lactose؛The patients suffering from uncontrolled cardiovascular and urinary and hematological and respiratory diseases؛ those have had known cancer and cancer history in the last 5 years؛ those suffering from metabolic disease؛ those have metabolic diseases and water and electrical imbalance and infection؛ past history of suffering from kidney stone disease؛age under 18 and above 70 years old.
The studied population :patients above 18 years old suffering from mild to moderate psoriasis that have the criteria for entering the study and who have tendency to participate in the study . In this study 90 patient will enter in two intervention and control group.The intervention group will receive whey protein with emollient ointment (20% glycerin) that (the patient was taking before the study) and the control group will receive placebo (lactose) and emollient ointment. Both groups will be synchronized on demographic data and topical ointment. The intervention group dissolve 10 grams of whey protein in a cup of warm water and when fasting in the morning they drink one third of cup every 15 minutes. The control group will receive placebo in the same way . Duration of consumption is 12 weeks. The primary outcomes of the study are:disease severity ،extent of lesion ،quality of life and severity of itching
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015100524359N1
Registration date:2015-11-13, 1394/08/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-11-13, 1394/08/22
Registrant information
Name
Akramosadat Atyabi
Name of organization / entity
School of Traditional Medicine of Tehran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 22988551
Email address
a-atyabi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2015-11-06, 1394/08/15
Expected recruitment end date
2016-02-04, 1394/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the effects of oral whey protein (an Iranian Traditional Medicine product) on improvement of mild to moderate skin lesion of psoriasis in comparison with placebo
Public title
Assessment of the effects of whey protein on psoriasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients above 18 years old ;skin involvement under 10 percent ;stable plaque psoriasis (which have been stable in extent and severity for at least 2 months) ; patients who haven’t been using psoralen for the past 28 days and UVB for the past 30 days ; patients who haven’t participated in any studies in the last month;patients who consent on participating in the study.
The criteria that impede patients from entering the study : age under 18 and above 70 years old ;Patients suffering from other kinds of psoriasis like pustular, erythrodermic, or palmoplantar or psoriatic arthritis or patient having their face involved;skin involvement more than 10 percent ; past history of allergy to lactose ;patients suffering from the kidney stone disease; patients who use drugs that intensify psoriasis e.g.Beta blockers ،NSAIDs،Antimalarials ،Terbinafine،Ca channel blockers،Interleukins and Lithium ;Oral corticosteroids or immunosuppressants consumption during the 4 weeks prior to baseline ;pregnancy and lactation ;The patients suffering from uncontrolled cardiovascular and respiratory and hematological and urinary diseases ;those who have known cancer and cancer history in the last 5 years، those have metabolic diseases and water and electrical imbalance and infection; any record of allergy ; acute sensitivity and progressive form of disease and tendency to erythrodermy ;patients who must use systemic psoriasis drugs; patients are dissatisfaction with participating in the study .
The criteria that lead to the exclusion of the patients who were participating in the study :
skin events after taking the drug during the study ; infection on the lesion during the study ; patients getting pregnant during the study ; patient suffering from the kidney stone disease during the study.
Age
From 18 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Science
Street address
Tehran University of Medical Science، Ghods street، Enghelabe Eslami street، Tehran، Iran
City
Tehran
Postal code
1417614411
Approval date
2015-09-29, 1394/07/07
Ethics committee reference number
IR.TUMS.REC.1394.859
Health conditions studied
1
Description of health condition studied
Psoriasis
ICD-10 code
L40.0
ICD-10 code description
Plaque psoriasis
Primary outcomes
1
Description
Severity
Timepoint
At baseline -end of 8 and 12 weeks
Method of measurement
psoriasis activity and severity index
2
Description
Extent of the lesion
Timepoint
At baseline -end of 8 and 12 weeks
Method of measurement
BODY SURFACE AREA
3
Description
quality of life
Timepoint
At baseline -end of 12 weeks
Method of measurement
persian valid version of Dermatology of life and quality index
4
Description
Intensity of pruritis
Timepoint
At baseline -end of 8 and 12 weeks
Method of measurement
VISUAL analog Scale
Secondary outcomes
1
Description
Evaluation of Possibe gastrointestinal and skin complications
Timepoint
End of 8 and 12 weeks
Method of measurement
CTCAE) common terminology for Adverse Event v40.2009)
2
Description
The photography of lesion
Timepoint
At baseline-end of 8 and 12 weeks
Method of measurement
The camera with 10 mega pixel sensor accuracy specifications .Canon EOS 400D Lens EFS18-55mm
Intervention groups
1
Description
The control group dissolve 10 gram of placebo(200 g=lactose and 100 g sugar )in a cup of warm water and when fasting they drink one third of cup every 15 minute.Meanwhile they will continue emollient ointment that have used before study .
Category
Placebo
2
Description
The intervention group dissolve 10 gram of whey protein in a cup of warm water and when fasting they drink one third of cup every 15 minute .Meanwhile they will continue emollient ointment that have used before study .
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Skin Clinic of Imam Khomeini
Full name of responsible person
Dr.Parvin Mansouri
Street address
Imam Khomeini Hospital ، The end of Keshavarz Blvd
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Leila shirbeigi
Street address
No.67، West jamali alley، Vafamanesh street ، Heravi square، Pasdaran ، Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Science
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
School of Traditional Medicine ,Tehran University of Medical Science,Tehran,Iran
Full name of responsible person
Akromosadat atyabi
Position
Assistant of traditional medicine
Other areas of specialty/work
Street address
No.67، West jamali alley، Vafamanesh street، Heravi square، Pasdaran ، Tehran
City
Tehran
Postal code
1668753963
Phone
+98 21 2298 8551
Fax
+98 22988551222
Email
a-atyabi@razi.tums.ac.iraatyabi113@gmail.com
Web page address
www.itm.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Traditional Medicine ,Tehran University of Medical Science,Tehran,Iran
Full name of responsible person
Akramosadat atyabi
Position
Assistant of traditional medicine
Other areas of specialty/work
Street address
No.67، West jamali alley، Vafamanesh street، Heravi square، Pasdaran ، Tehran
City
Tehran
Postal code
1668753963
Phone
+98 21 2298 8551
Fax
+98 22988551222
Email
a-atyabi@razi.tums.ac.iraatyabi113@gmail.com
Web page address
www.itm.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
School of Traditional Medicine ,Tehran University of Medical Science,Tehran,Iran
Full name of responsible person
Akramosadat atyabi
Position
Assistant of traditional medicine
Other areas of specialty/work
Street address
No.67، West jamali alley، Vafamanesh street، Heravi square، Pasdaran ، Tehran
City
Tehran
Postal code
1668753963
Phone
+98 21 2298 8551
Fax
+98 22988551222
Email
a-atyabi@razi.tums.ac.iraatyabi113@gmail.com
Web page address
www.itm.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)