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IRCT20250926067366N1 IRCT 2025-10-05 Shiraz University of Medical Sciences Therapeutic Effects of Oral and Topical Curcumin in the Treatment of Eczema Comparison of the Effectiveness of Oral and Topical Curcumin versus Placebo in Improving Disease Severity, Itching, and Quality of Life in Patients with Mild to Severe Eczema 2025-10-23 anticipated 72 Complete https://irct.ir/trial/86485 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: The present study is a cross-sectional, single-blind, placebo-controlled clinical trial, which can be considered applied based on its objectives, Randomization description: In this study, a completely randomized block design was used. To allocate patients to the treatment and control groups, a randomized permuted block method was applied. Blocks were defined according to eczema severity (mild, moderate, and severe), and allocation within each block was performed randomly. Patients were enrolled in the study voluntarily after signing an informed consent form. At the first visit, demographic information (age and sex), eczema severity based on the Eczema Area and Severity Index (EASI), Scoring Atopic Dermatitis (SCORAD), pruritus based on the Visual Analog Scale (VAS), and skin-related quality of life using the Dermatologic Life Quality Index (DLQI) were collected. Then, patients were assigned using the randomized permuted block method into three groups according to eczema severity (mild, moderate, and severe). These three groups included two experimental groups and one control group, with allocation performed using simple randomization, Blinding description: This study was conducted as a single-blind trial, in which only the participants were unaware of the type of treatment they received (oral curcumin, topical curcumin, or placebo). The treatment staff and outcome assessors were aware of the patients’ treatment allocation. This blinding method was applied to reduce the subjective influence of participants on outcome assessment and to enhance the validity of the collected data. 3 Eczema. Intervention 1: Intervention group:1:Oral curcumin: Abureyhan curcumin capsules 500 mg, administered at a dose of 1000 mg per day (two 500 mg capsules). Intervention 2: Intervention group:2:Topical curcumin: Sinacurcumin nanomicelle soft gel 80 mg, applied twice daily to the lesions. Intervention 3: Control group: Two placebos were used simultaneously: oral placebo (tablet, once daily) and topical placebo (cold cream, applied twice daily to the lesions). Yes - There is a plan to make this available What will be shared: Comparison of the Therapeutic Effects of Oral and Topical Curcumin in Patients with Eczema and Its Evaluation Compared with Placebo in Patients Attending Imam Reza Clinic, Shiraz, During 2024–2025 When: Six months after the publication of the results To whom: The data will only be accessible to authorized individuals related to the study, including the principal investigator, authors, advisors, reviewers, relevant staff, and researchers affiliated with the relevant academic and scientific institutions Conditions: The data may only be used if a favorable outcome indicating improvement of skin eczema is achieved and approved by the Food and Drug Administration Where to obtain: The data can be obtained from the supervisors,investigator and author associated with the study: Principal supervisor of the study:Dr.Seyed Hesam Nabavi Zadeh,Contact number: 0098917 111 0867 Study investigator and author: Dr. Elham Amini, Contact number:00989360903621 How to obtain: 1. Submission of a written request to the principal investigator stating the reason for requesting the data and the extent of the data needed. 2. Completion of the study data request form. 3. Review of the request by the principal investigator. 4. Approval or rejection of the request. 5. If approved, establishing contact between the applicant and the study investigator. 6. Completion of a guarantee form confirming the non-disclosure of the data Comments:
public Elham Amini
No.3,Valiasr alley,Ghasrodasht Ave
Shiraz Iran (Islamic Republic of) ۷۱۸۳۸۹۶۵۱۷ +98 71 3628 0318 amini.elham9170@yahoo.com Shiraz University of Medical Sciences scientific Elham Amini
No.3,Valiasr alley,Ghasrodasht Ave
Shiraz Iran (Islamic Republic of) ۷۱۸۳۸۹۶۵۱۷ +98 71 3628 0318 amini.elham9170@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Patients aged 18 to 65 years ‏Suffering from mild, moderate, or severe eczema based on Eczema Area and Severity Index Patients who have not previously received any treatment for eczema 18 years 65 years Both Lack of consent to participate in the study Significant organ dysfunction Cutaneous malignancies Generalized eczema Pregnant or breastfeeding women Women of childbearing age who do not use adequate contraception Inability to adhere to treatment or attend regular follow-up visits L20.84 Intrinsic (allergic) eczema Treatment - Drugs Treatment - Drugs Placebo Intervention group:1:Oral curcumin: Abureyhan curcumin capsules 500 mg, administered at a dose of 1000 mg per day (two 500 mg capsules) Intervention group:2:Topical curcumin: Sinacurcumin nanomicelle soft gel 80 mg, applied twice daily to the lesions. Control group: Two placebos were used simultaneously: oral placebo (tablet, once daily) and topical placebo (cold cream, applied twice daily to the lesions). Eczema severity. Timepoint: Data were collected and analyzed at baseline and after two weeks and four weeks of treatment. Method of measurement: Assessed using the Eczema Area and Severity Index (EASI) or Scoring Atopic Dermatitis (SCORAD). Pruritus severity. Timepoint: Data were collected and analyzed at baseline and after two weeks and four weeks of treatment. Method of measurement: Assessed using the Visual Analog Scale (VAS). Skin-related quality of life. Timepoint: Data were collected and analyzed at baseline and after two weeks and four weeks of treatment. Method of measurement: Assessed using the Dermatologic Life Quality Index (DLQI). Shiraz University of Medical Sciences Approved 2025-04-22 Ethics committee of Shiraz University of Medical Sciences Ghasrodasht Street, Alley 3 Vali Asr, Sub-alley 3/2 Shiraz Fars Iran (Islamic Republic of)