Psoriasis: This study specifically focuses on evaluating the impact of a nutritional regimen and complementary supplements on managing symptoms of plaque psoriasis, a chronic autoimmune condition characterized by scaly, reddened skin patches. The findings are intended to contribute to the field by offering non-pharmaceutical interventions to improve the quality of life and reduce the severity of symptoms for individuals affected by this condition.. The ICD-10 code for psoriasis is L40. Psoriasi
Conditions
Interventions
Intervention group: In this clinical trial to evaluate the effectiveness of a nutritional regimen and complementary supplements for treating psoriasis, the study design includes multiple intervention
Sponsors
College of Nursing, University of Mosul
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Diagnosis of Plaque Psoriasis: Confirmed by a dermatologist through physical examination. Disease Severity: Participants might be categorized by the severity of their condition, such as mild or moderate, often defined by the Psoriasis Area and Severity Index (PASI). Age Criteria: Depending on the study, it might include adults. Plaque Characteristics: Participants could be required to have a certain number and size of plaques, not currently responding to over-the-counter treatments. Stable Condition: Often, studies require that the participant’s condition is stable for a certain period prior to enrollment, without flare-ups or significant worsening.
Exclusion criteria
Exclusion criteria: Other Forms of Psoriasis: Exclude individuals with different types of psoriasis, such as guttate. Recent Use of Certain Medications: Participants who have used systemic treatments (like biologics, methotrexate, cyclosporine) or phototherapy within a specific timeframe before the study begins may be excluded to avoid their effects on the study outcomes. Comorbid Conditions: Exclude individuals with significant comorbid conditions that could interfere with the treatment's effectiveness or the disease’s natural history, such as uncontrolled cardiovascular diseases, active infections, or cancer. Pregnancy or Lactation: Due to potential risks to the fetus or newborn, pregnant or lactating women are often excluded unless the study specifically addresses these populations. Skin Conditions: Exclude individuals with other active skin diseases or infections that could complicate diagnosis or interfere with assessing psoriasis. Allergy to Study Medications: Individuals with known allergies to the study medication or related compounds should be excluded to prevent adverse reactions. Previous Participation: Often, studies exclude individuals who have participated in other clinical trials recently to avoid overlapping effects or biased responses.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In clinical research, the primary outcome variable is crucial as it directly assesses the effectiveness of an intervention. It's the main result that the study is designed to measure, determining whether the intervention has a significant effect compared to the control or other treatment conditions. In planning a study, the choice of the primary outcome variable is fundamental because it guides the study design, including the determination of sample size. Adequate sample size calculation is essential to ensure the study has enough power to detect a clinically significant difference in the primary outcome if one exists.For example, in a study assessing the impact of a dietary intervention on psoriasis, possible primary outcome variables could include:Psoriasis Area and Severity Index (PASI) Score: This is a widely used quantitative tool for measuring the severity and extent of psoriasis, combining the assessment of the severity of lesions and the area affected into a single score.Quality of Life (QoL) Assessments: These could involve validated dermatology-specific instruments to measure the impact of psoriasis on patients' daily lives and mental health.When more than one primary outcome is used, it's often because the study aims to assess multiple dimensions of an intervention's effectiveness. However, having multiple primary outcomes requires careful statistical handling to adjust for the risk of type I errors (false positives), and it’s essential to clearly define and justify each primary outcome in the study protocol. Timepoint: In the context of a clinical study investigating the effects of a nutritional regimen and complementary supplements on psoriasis, it's essential to measure the primary outcomes at specified time intervals to accurately assess the intervention's impact over time. Here’s a proposed schedule for measuring the primary outcomes:Baseline Measurement: Before the intervention begins, to establish a reference point for each participant's condition. | — |
Countries
Iraq
Contacts
Public ContactFeada Edin Ali
College of Nursing, University of Mosul
Outcome results
None listed