Evaluation of the efficacy of Ursodeoxycholic acid plus methotrexate compared with methotrexate alone on faster improvement of patients with plaque-type psoriasis
Psoriasis is a chronic inflammatory skin disease, and its treatment is very important due to psychological complications and disability.
It involves approximately two to four percent of the world's population and has various clinical manifestations. In the most common type of the disease, it is characterized by scaly red plaques.
Although the precisely molecular mechanisms of the disease are still largely unknown, but finding the biochemical mechanisms involved in its pathogenesis has played an important role in discovering new therapies and better control of the disease.
One of the environmental triggers that initiates psoriasis is bacterial infection.
Recent studies have shown the effect of anti-microbial activity for bile acids and decreasing microbial growth in the presence of high concentrations of bile acids has been reported.
Several case-report studies have shown the efficacy of bile acids with a favorable safety profile when used in the treatment of patients suffering chronic plaque-type psoriasis. However, the use of Ursodeochycholic acid for the treatment of psoriasis is still uncertain, therefore it is needed to develop a comprehensive study in this regard. If the beneficial effect of ursodeoxycholic acid in the treatment of patients with psoriasis is proven, then we can use it as an adjunct to the treatment of these patients. Ursodeoxycholic acid is relatively inexpensive and has limited side effects, so this will undoubtedly has a significant effect on accelerating the treatment process and reducing the cost of treatment for these patients.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017092536415N1
Registration date:2017-11-13, 1396/08/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-11-13, 1396/08/22
Registrant information
Name
Amine Kashiri
Name of organization / entity
Tehran university medical science
Country
Iran (Islamic Republic of)
Phone
+98 17 3232 7217
Email address
a-kashiri@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2017-10-22, 1396/07/30
Expected recruitment end date
2018-06-21, 1397/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy of Ursodeoxycholic acid plus methotrexate compared with methotrexate alone on faster improvement of patients with plaque-type psoriasis
Public title
The efficacy of Ursodeoxycholic on faster improvement of patients with psoriasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with psoriasis who are candidated for systemic therapy; they have not received systemic therapy as well as phtotherapy for their disease during the past 6 month; they have not received topical treatment over the past month.
Exclusion criteria: patients with history of heart failure, hepatic, renal and pulmonary disease or icreasement in liver function tests(More than 1.5 times normal), diabetes mellitus and other serious systemic disease; pregnant women; since the efficacy and safety of using Uroseodocyclic acid in the pediatric population has not been established, this group will also be excluded from the study; People with a history of biliary disorders, and hypersensitivity to bile acids
Age
From 15 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee on Research in Tehran University of Medical Sciences
Street address
room 105, fifth floor, central building of Tehran University of Medical Sciences, Qods St, Keshavarz Blvd, Tehran, Iran
City
Tehran
Postal code
1417653761
Approval date
2017-09-10, 1396/06/19
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1396.3405
Health conditions studied
1
Description of health condition studied
Psoriasis
ICD-10 code
L40.0
ICD-10 code description
psoriasis vulgaris
Primary outcomes
1
Description
Psoriasis area and severity index
Timepoint
Before intervention, two months after the intervention, six months after the intervention
Method of measurement
FotoFinder PASIvision
2
Description
Dermatology Life Quality Index
Timepoint
Before intervention, two months after the intervention, six months after the intervention
Method of measurement
Questionnaire
Secondary outcomes
1
Description
liver enzymes
Timepoint
Before intervention, two months after the intervention, six months after the intervention
Method of measurement
lab tests
2
Description
Serum lipid level
Timepoint
Before intervention, two months after the intervention, six months after the intervention
Method of measurement
lab tests
3
Description
Fatty liver
Timepoint
Before intervention, two months after the intervention, six months after the intervention
Method of measurement
Sonography
Intervention groups
1
Description
Intervention group: taking capsules containing 300 mg of Ursudocysical colic acid once a day for six months
Category
Treatment - Drugs
2
Description
control group: taking placebo as a capsule of 300 mg once a day
Research Deputy of Tehran University of Medical Sciences, Central building of Tehran University of Medical Sciences, Qods intersection, Keshavarz Blvd, Tehran, Iran
City
Tehran
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?