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IRCT20220616055195N1 IRCT 2023-03-13 Mashhad University of Medical Sciences Effect of Dorema ammoniacum ointment on psoriasis The effect of Dorema ammoniacum topical ointment on mild to moderate plaque psoriasis 2023-03-05 anticipated 64 Complete https://irct.ir/trial/68043 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block method Allocation Concealment : closed and sealed envelopes triple blinded : people under study assesors analystic in the placebo group the patient is unaware of the type of ointment . instead of intervention and control group A and B are used to blind the analyst . the evaluation of the outcome is done by a person outside the research group , Blinding description: In the placebo group the patient is unaware of the type of ointment . instead of intervention and control group A and B are used to blind the analyst . the evaluation of the outcome is done by a person outside the research group . 3 chronic plaque psoriasis. Intervention 1: Intervention group: The ointment contains D0orema ammoniacum and OSERIN which is used on the lesion twice a day for two months. The ointments are formulated and provided by a pharmacist at the pharmaceutical laboratory of the school of Persian and complementary medicine at Mashhad University of Medical Sciences. Intervention 2: Control group: In the control group, topical ointment with the same color, smell, and consistency as the original ointment is used on the lesion twice a day for two months. The ointments are formulated and provided by a pharmacist at the pharmaceutical laboratory of the school of Persian and complementary medicine at Mashhad University of Medical Sciences. Yes - There is a plan to make this available What will be shared: Personal data of study participants can be shared after de-identification. When: The access period starts 6 months after the results are published To whom: Researchers working in academic and scientific institutions and people working in the industry. Conditions: Approved for use in the treatment of patients with plaque psoriasis Allowed for other statistical analyses Where to obtain: From Zahra Naseripour Yazdi with email address: Naseripz981@mums.ac.ir Phone number: 009809157101309 How to obtain: After mentioning the name and organization of the user and explaining the type of use of the information in the email address The specifications will be checked and will be made available after one month. Comments:
public Zahra Naseriporyazdi
No. 60, Imam Reza 10, Vilashahr
Mashhad Iran (Islamic Republic of) 09117507723 +98 915 710 1309 Ù”Naseripz981@mums.ac.ir Mashhad University of Medical Sciences scientific Dr. Alireza Derakhshan
School of Persian and Complementary Medicine, University campus, Azadi Square
Mashhad Iran (Islamic Republic of) 9177899191 +98 51 3841 2081 derakhshanAR@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Chronic plaque form psoriasis patients Plaque size : lower than 10 % Age : older than 12 years old 12 years no limit Both Taking topical medicine in the last 14 days and systemic drug in the 30 last days Pregnancy or planning to be pregnant or breast feeding History of allergy to herbal medicines Presence of abnormal laboratory finding Taking local or systemic medicine that has a positive or negative effect on the course of the disease Having serious liver or kidney disease L40.0 Psoriasis vulgaris Treatment - Drugs Treatment - Drugs Intervention group: The ointment contains D0orema ammoniacum and OSERIN which is used on the lesion twice a day for two months. The ointments are formulated and provided by a pharmacist at the pharmaceutical laboratory of the school of Persian and complementary medicine at Mashhad University of Medical Sciences. Control group: In the control group, topical ointment with the same color, smell, and consistency as the original ointment is used on the lesion twice a day for two months. The ointments are formulated and provided by a pharmacist at the pharmaceutical laboratory of the school of Persian and complementary medicine at Mashhad University of Medical Sciences. Plaque-type psoriasis patients with lesion involvement less than 10%. Timepoint: before the start of the intervention, day 14, day 28, day 42 and day 56 after the start of the intervention. Method of measurement: PASI questionnaire and DLQI questionnaire. Investigating the quality of life based on the DLQI questionnaire. Timepoint: Before the intervention, week 2, week 4, week 6, week 8 after the intervention. Method of measurement: Dermatology Questionnaire for Quality of Life (DLQI). Mashhad University of Medical Sciences Approved 2022-11-19 Ethics Committee of Mashhad University of Medical Sciences School of medicine, Kalantari Blvd, Azadi Square Mashhad Razavi Khorasan Iran (Islamic Republic of)