A COMPARATIVE PROSPECTIVE STUDY ON THE EFFICACY AND SAFETY OF LOW DOSE CYCLOSPORINE WITH LEVOCETIRIZINE VERSUS LEVOCETIRIZINE PER SE IN CASES OF CHRONIC SPONTANEOUS URTICARIA
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- At the end of the study, the efficacy of low dose cyclosporine with levocetirizine and of levocetirizine alone in management of chronic spontaneous urticaria will be ascertained. Further a comparison between the two modalities in terms of efficacy and safety will be better understood.
研究概览
简要总结
Urticaria is a heterogenous skin disorder associated with raised, well defined areas of erythema, edema and itching. It is also known as Hives. The lesions resolve spontaneously within 24 hours without any scar or residual pigmentation. Based on its duration, Urticaria can be divided into two categories: acute and chronic. Acute, which lasts less than six weeks, and Chronic, which lasts longer than six weeks. Chronic Urticaria can be further classified into chronic spontaneous urticaria and chronic inducible urticaria (triggering factors can be idiopathic, cold contact, heat exposure, vertical pressure, UV light, mechanical force, sweating, exercise). The term Chronic spontaneous urticaria refers to urticaria (hives) that occur three to four times a week, continue six weeks or longer, and have no recognized cause. It has a peak incidence between the ages of 20 and 40 years, lasting one to five years in most patients, but even longer in severe cases. Women are affected twice as often as men. o It can cause significant distress to the patients socially, emotionally and interfere with day-to-day activities. Various anti-histamines have been used for treating urticaria. The first-line therapy involves non- or minimally sedative second-generation antihistamine medications, the dose of which may be increased up to 4 times for those who do not respond. Combining various anti-histaminic medications is part of second-line therapy. Third-line therapy includes more recent medications such as omalizumab and cyclosporine. o Cyclosporine is an immunosuppressive agent which has shown to be effective in patients with chronic spontaneous urticaria not responding to regular 1st line therapy of second generation non or low sedating anti histamines. Recent studies have demonstrated a notable improvement in chronic urticaria that is not improving with first and second therapy when a low dose of cyclosporine medication (2-4 mg/kg/day) is administered for 12 weeks 7 o Levocetirizine is a second generation H1 blocker. It is an inverse agonist on histamine receptors. They do not easily pass through the blood–brain barrier, thereby minimizing the side effect of sedation. It acts by stabilization of mast cells. It is the 1st line drug in treatment of Chronic Urticaria. The standard dose in treatment of Chronic Urticaria is 5mg per day. It may be escalated to up to 4 times the standard dose based on the response of the patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 15.00 Year(s) 至 80.00 Year(s)(—)
- 性别
- All
入选标准
- •All patients above 15 years of age will be included in the study.
- •All patients with a clinical diagnosis of chronic spontaneous urticaria for more than 6 months duration not responding to conventional lines of treatment will be included in the study.
- •Patients with UAS-7 score more than 16 will be included in the study.
排除标准
- 未提供
结局指标
主要结局
At the end of the study, the efficacy of low dose cyclosporine with levocetirizine and of levocetirizine alone in management of chronic spontaneous urticaria will be ascertained. Further a comparison between the two modalities in terms of efficacy and safety will be better understood.
时间窗: At the end of the study, the efficacy of low dose cyclosporine with levocetirizine and of levocetirizine alone in management of chronic spontaneous urticaria will be ascertained. Further a comparison between the two modalities in terms of efficacy and safety will be better understood.
次要结局
未报告次要终点
研究者
SAKSHAM MEHTA
SUMANDEEP VIDYAPEETH DEEMED TO BE UNIVERSITY
