Evaluation of the Effect of Acetylcysteine and Vitamin E on Psoriasis Vulgaris Patients During The Active Phase
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- level of interleukin-36(IL-36 gamma) (Pg/ml)
研究概览
简要总结
This study aims to assess the effect of adding N-acetyl cysteine (NAC) alone or in combination with Vitamin E to conventional therapy in improving the clinical outcome, oxidative stress, and inflammation in patients with mild psoriasis vulgaris
详细描述
The study will include 60 Mild psoriatic patients in the active phase (score <, =3) using PASI score. The PASI is a widely used instrument that assesses and grades the severity of psoriatic lesions and the patient's response to treatment. They will assigned randomly into 3 groups. Each group will contain 20 patients. the first group will receive Standard treatment for mild psoriatic patients (topical steroid and salicylic acid), the second group will receive Standard treatment for mild psoriasis, plus N acetyl cysteine (600 mg a day) oral, 30 minutes before breakfast, for 8 weeks. the third group will receive Standard treatment for mild psoriasis, plus N acetyl cysteine (600 mg a day) oral effervescent sachet,30 minutes before breakfast Plus, vitamin E (1000 mg) daily, oral soft gelatin capsule for 8 weeks.
PASI=Psoriasis Area and Severity Index
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult Patients from 18 to 65 years.
- •Gender: both males and females.
- •Mild psoriatic patients in the active phase (score < =3)
- •Patients diagnosed with mild psoriasis in the active phase (score less than or equal 3) using PASI score.
排除标准
- •Inactive psoriasis vulgaris patients.
- •Alcohol consumption
- •Any other autoimmune diseases.
- •Pregnant or lactating women.
- •Patients with serious illness and any systemic failure (cardiovascular, renal, or respiratory)
- •Patients with major psychiatric or mental illness.
- •Intake of any antioxidants in the previous 3 months
- •Patients of chronic diseases, like hypertension, heart problems
- •Patients with history of bleeding, ulcers, or uncontrollable heartburn.
- •Patients taking anticancer medications that can aggravate psoriasis vulgaris such as mercaptopurine, vinblastine, actinomycin, and Radiation
研究组 & 干预措施
mix acetylcysteine with vitamin E
Standard treatment for mild psoriasis, plus N acetyl cysteine (600 mg a day) oral effervescent sachet,30 minutes before breakfast Plus, vitamin E (1000 mg) daily, oral soft gelatin capsule for 8 weeks
干预措施: Acetyl cysteine (Drug)
mix acetylcysteine with vitamin E
Standard treatment for mild psoriasis, plus N acetyl cysteine (600 mg a day) oral effervescent sachet,30 minutes before breakfast Plus, vitamin E (1000 mg) daily, oral soft gelatin capsule for 8 weeks
干预措施: Vitamin E (Drug)
acetylcysteine
Standard treatment for mild psoriasis, plus N acetyl cysteine (600 mg a day) oral effervescent sachet, 30 minutes before breakfast, for 8 weeks
干预措施: Acetyl cysteine (Drug)
结局指标
主要结局
level of interleukin-36(IL-36 gamma) (Pg/ml)
时间窗: 4 months
measuring level of interleukin-36(IL-36 gamma) at baseline before the intervention and during taking the intervention and 1 month after stopping taking the intervention
level of Malondialdehyde (MDA) (µmol/L)
时间窗: 4 months
measuring level of malondialdehyde (MDA) at baseline before the intervention and during taking the intervention and 1 month after stopping taking the intervention
次要结局
未报告次要终点
研究者
Naira abbas hassan Elkalla
teaching assistant of clinical pharmacy department at BUC
Badr University