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IRCT20260215068870N1 IRCT 2026-04-22 Bagheiat-allah University of Medical Sciences Neem oil in psoriasis vulgaris Investigating the effects of neem oil (Azadirachta Indica)in improving the skin manifestations of psoriasis vulgaris patients 2026-04-20 anticipated 34 Complete https://irct.ir/trial/89441 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, block randomization using four-block permutations with random order will be employed. In this method, treatment blocks are randomly arranged forward and backward. For example, with a block length of 4 and two treatment groups, the following permutations are possible: ABBB, ABAB, ABBA, BABA, BAAB, BBAA. By randomly combining these blocks, a balanced randomization list of the two treatment groups is obtained, Blinding description: To reduce bias in this clinical trial, the blinding process is designed as follows: Data Analyst Blinding: After data collection, information regarding patient grouping (intervention or control group) will be removed from the database and replaced with numerical codes. The data analyst will work exclusively with numerical codes and will remain unaware of patient treatment allocation. The code-to-treatment group mapping table will be maintained by the principal investigator, and codes will be revealed only after completion of the initial statistical analysis. Outcome Assessor Blinding: Assessment of primary outcomes (PASI index, DLQI questionnaire, and patient satisfaction) will be performed by an individual who is not involved in the randomization process or patient treatment. This assessor is not aware of the treatment group assigned to each patient, and assessments are conducted without knowledge of group allocation. 2-3 Psoriasis vulgaris. Intervention 1: Intervention group: Patients in this group, in addition to standard treatment (topical betamethasone 0.05% corticosteroid), use pure neem oil (Azadirachta Indica) once daily topically on psoriatic lesions. Intervention 2: Control group: Patients in this group topical betamethasone 0.05% corticosteroid (twice daily for 2 months) topically on psoriatic lesions. Yes - There is a plan to make this available What will be shared: Clinical Trial Data: The collected data includes patient demographic data (age, gender), Psoriasis Area and Severity Index (PASI) scores at baseline, one month, and two months after treatment initiation, Dermatology Life Quality Index (DLQI) questionnaire, patient satisfaction scores using Likert scale (1-5), information regarding underlying diseases and family history of psoriasis. After de-identification, fully anonymized individual-level data will be available for sharing. When: Access Period Start: 12 months after completion of data collection and publication of final study results. Considering the 2-month implementation period, data access is expected to be available from late 2026. Data will be accessible to applicants for 5 years after initial publication. To whom: All researchers employed in accredited academic and research institutions, researchers in pharmaceutical and cosmeceutical industries, graduate students (Master's and PhD) in dermatology and pharmacy-related fields, and dermatology specialists may request access to anonymized data. Applicants must state a clear purpose for data use. Conditions: - Data may only be used for research purposes (including meta-analysis, secondary studies, and validation of findings). - Commercial use requires a separate agreement and prior notification. - Permitted analyses include descriptive, comparative, and statistical modeling analyses. - Applicants must properly cite the original study in any publications derived from these data. - Any re-analysis must be approved by the relevant ethics committee. Where to obtain: To obtain the data or documents, applicants may contact Dr. Majid Shahrati (Principal Investigator) at phone number +98-21-82483388 or by mail at: Tehran, Baqiyatallah Hospital, Faculty of Pharmacy, Clinical Research Development Unit. After registration of the clinical trial in the IRCT system, the email address and study website will also be announced through the system. Telephone contact is recommended as the first and fastest method of communication. How to obtain: The request process begins with applicants submitting a written request including their research purpose, research proposal, and confidentiality agreement. The principal investigator will then review the request and announce the decision within 3 weeks (1 week for initial review and 2 weeks for final decision). If approved, a data use agreement will be sent, and after signing, the data will be provided within 1 week. Overall, the entire process from request submission to data receipt takes approximately 4-5 working weeks. Comments:
public Dr. Majid Shohrati
Baqiyatallah hospital, Mollasadra Street, Vanak, Tehran, Iran
Tehran Iran (Islamic Republic of) 1435915371 +98 917 228 2616 majidshohrati@gmail.com Bagheiat-allah University of Medical Sciences scientific Dr. Majid Shohrati
Baqiyatallah hospital, Mollasadra Street, Vanak, Tehran, Iran
Tehran Iran (Islamic Republic of) 1435915371 +98 917 228 2616 majidshohrati@gmail.com Bagheiat-allah University of Medical Sciences Iran (Islamic Republic of) Adults (18 years or older) diagnosed with psoriasis vulgaris Patients with mild to moderate psoriasis 18 years no limit Both Presence of other skin diseases Nail involvement in psoriasis Use of neuropsychiatric medications such as lithium or drugs like beta-blockers and hydroxychloroquine Concurrent use of systemic or biological treatments for psoriasis Presence of other significant skin diseases Known allergies or sensitivities to neem oil L40.0 Psoriasis vulgaris Treatment - Drugs Treatment - Drugs Intervention group: Patients in this group, in addition to standard treatment (topical betamethasone 0.05% corticosteroid), use pure neem oil (Azadirachta Indica) once daily topically on psoriatic lesions. Control group: Patients in this group topical betamethasone 0.05% corticosteroid (twice daily for 2 months) topically on psoriatic lesions. Psoriasis Area and Severity Index (PASI). Timepoint: Three time points: 1-Before treatment initiation (Baseline) 2-One month after treatment start 3-Two months after treatment start. Method of measurement: Clinical assessment by a dermatologist using the standard PASI index form. Scoring is based on four body regions (head/neck, trunk, upper extremities, lower extremities) and three parameters (erythema, induration, scaling) considering the percentage of involved area. Dermatology Life Quality Index (DLQI). Timepoint: Three time points: 1-Before treatment initiation (Baseline) 2-One month after treatment start 3-Two months after treatment start. Method of measurement: Completion of the standard DLQI questionnaire by the patient. Each question has 4 responses (0-3) with a maximum total score of 30. Higher scores indicate lower quality of life. Patient's satisfaction level. Timepoint: Three time points: 1-Before treatment initiation (Baseline) 2-One month after treatment start 3-Two months after treatment start. Method of measurement: Using a 5-point Likert scale:1 = Completely dissatisfied2 = Dissatisfied3 = Neutral4 = Satisfied5 = Completely satisfied. Bagheiat-allah University of Medical Sciences Approved 2026-02-02 Ethics committee of Baqiyatallah University of Medical Sciences Baqiyatallah University of Medical Sciences, Mollasadra Street, Vanak, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)