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IRCT20080901001157N20 IRCT 2023-03-29 Islamic Azad University The effect of Artemisia herbal cream product on improving the symptoms of patients with psoriasis Investigation of the safety and efficacy of Artemisia herbal cream product for the improvement and treatment of psoriasis skin patients 2023-04-03 anticipated 30 Complete https://irct.ir/trial/69095 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random assignment to intervention and control groups. A random number table and block randomization method is used. In this method 60 eligible patients are assigned into 30 blocks of 2 patients. Then, each of the 2 patients in the block is randomly assigned to take herbal cream or standard cream, so that 30 patients assigned to each group, Blinding description: After making creams containing artemisia extract and creams containing Clobetasol (the main drug) and comparing the organoleptic characteristics of both types of creams, including color and smell, the creams were packed in a completely similar package and one person outside the study Creams containing artemisia extract or creams containing Clobetasol are assigned one of the two codes A or B so that the patients, the project managers, the specialist doctor and the person in charge of data analysis do not know about the content of creams A or B during the study. . 2 Condition 1: Psoriasis. Condition 2: Other psoriasis. Condition 3: Moderate to severe psoriasis. Intervention 1: Intervention group: for 3 weeks, the patients of this group used a 60-gram tube of plant extract cream containing artemisia extract, wheat germ oil, jojoba oil, avocado oil, and pomegranate seed oil every night for 3 weeks. They use it locally on the lesions specified by the doctor. Intervention 2: Control group: The patients of this group use the cream containing Clobetasol topically on the lesions specified by the doctor, every night for 3 weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Only the results are published in the form of articles.
public Nasrin Razavianzadeh
University Blvd, Khatam al-Anbia hospital
Shahrood Iran (Islamic Republic of) 3619943189 +98 23 3223 1442 nasrinrazavianzadeh@gmail.com Islamic Azad University scientific Mohammadreza Gholibeikian
No. 26, Nader Alley, North Jamalzadeh St, Enghelab Square
Tehran Iran (Islamic Republic of) 1418635643 +98 21 6276 9000 mgholibeikian@gmail.com Homapharmed Company Iran (Islamic Republic of) Patients with psoriasis. 15 to 50 years old who are able to use the topical product. Personal desire to participate in the project and the signing of a written consent. 15 years 50 years Both People who are allergic to plant extracts and Artemisia annua plant extract. pregnant women. Lactating women. Patients treated for systemic psoriasis 3 months before and during the study. Patients who have a history of malignant disease, taking anti inflammatory and immunosuppressive drugs. L40.0 L40.8 L40.1 Psoriasis vulgaris Other psoriasis Generalized pustular psoriasis Treatment - Drugs Placebo Intervention group: for 3 weeks, the patients of this group used a 60-gram tube of plant extract cream containing artemisia extract, wheat germ oil, jojoba oil, avocado oil, and pomegranate seed oil every night for 3 weeks. They use it locally on the lesions specified by the doctor. Control group: The patients of this group use the cream containing Clobetasol topically on the lesions specified by the doctor, every night for 3 weeks. Erythema (redness) of Psoriasis rashes. Timepoint: At the beginning of the study (before the start of the intervention) and after three weeks (end of the study). Method of measurement: Observation. PASI number suitable for each patient (severity index of the psoriasis area). Timepoint: At the beginning of the study (before the start of the intervention) and after three weeks (end of the study). Method of measurement: The software for calculating the severity index of psoriasis area version 2.7.1. The thickness and prominence of psoriasis rashes. Timepoint: At the beginning of the study (before the start of the intervention) and after three weeks (end of the study). Method of measurement: Observation. Flaking. Timepoint: At the beginning of the study (before the start of the intervention) and after three weeks (end of the study). Method of measurement: Observation. Level of conflict. Timepoint: At the beginning of the study (before the start of the intervention) and after three weeks (end of the study). Method of measurement: Ruler (cm). Intensity of itching. Timepoint: At the beginning of the study (before the start of the intervention) and after three weeks (end of the study). Method of measurement: Using a visual scale with scoring by patients from 0 (no itching) to 10 (the most severe itching). Patient satisfaction. Timepoint: After completing the study. Method of measurement: VAS index (visual analog scale) which is a 10-point scale and shows the quality of the patient in the form of quantity with numbers. Side effects of the drug. Timepoint: During the study. Method of measurement: Questionnaire and specialized visit by a dermatologist. Islamic Azad University Approved 2023-02-15 Research ethics Committees of Islamic Azad University, Shahrood Branch Islamic Azad University, Shahrood Branch Shahrood Semnan Iran (Islamic Republic of)