-
Study aim
-
Investigating the therapeutic effect of Dorema ammoniacum ointment on improving psoriasis skin lesions
-
Design
-
clinical trial ; three blind study ; phase 3
The sample size was calculated by using the PASS software and for the test of the difference between the average pass score of two independent groups and considering the power of 90% and the confidence of 95% and the standard deviation of 3 and the effect size of 2.5 units in each group of 32 people, which considering It was determined that 3 people drop out in each group of 35 people.
-
Settings and conduct
-
Patients with psoriasis referred to Imam Reza Hospital in Mashhad, which has inclusion criteria, are assigned to intervention and control groups and receive Dorema ammoniacum ointment or placebo for four weeks. Clinical symptoms will be evaluated based on the PASI score at the beginning and end of the study. Patients, outcome evaluator and data analyst will be blind.
-
Participants/Inclusion and exclusion criteria
-
Inclusion criteria: Age 12 years and older, Suffering from chronic plaque-type psoriasis, The extent of infection is less than 10% of the body's surface
Exclusion criteria: Having serious liver or kidney diseases, Using topical medicine in the last 14 days and systemic medicine in the last 30 days, Pregnancy or planning to become pregnant, breastfeeding, History of allergy to herbal medicines, Abnormal laboratory findings, Taking local or systemic medications that have a positive or negative effect on the course of the disease.
-
Intervention groups
-
intervention , the test group consisted of ointment containing 15% ash, 10% vinegar, 20% wheat oil and 55% oserin.
In the control group, topical ointment with the same color, smell and consistency as the original ointment is used.
-
Main outcome variables
-
Measurement of extent ٬ inflammation and scaling of the lesion