CTRI/2017/10/010232已完成3 期
Randomized open label parallel comparative study of efficacy tolerability and safety of bepotastine besilate 20mg versus levocetrizine 5mg in patients with chronic spontaneous urticaria in a tertiary care centre
Dr E Gayathri1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年1月12日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- It is the change from baseline in mean weekly Urticaria activity score-7( i.e the sum of the daily UAS i.e.(sum of wheal & itching day and night time score) self evaluation scores of 7 individual days,which could range between 0 to 42 per week) after 4 weeks of treatment
研究概览
简要总结
. The patients will be assessed for the followingscales before the beginning of study, during the course of treatment and at theend of study.
1. Urticaria Activity score
2. Chronic Urticaria quality of life questionnaire
3. Dermatology life quality index
4. Patients global assessment of their symptoms
5. Clinical Global Impression – Global Improvement (CGI –I) Scale
Visualanalogue scale measuring day time sedation
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female patients, aged 18-70 years old, with a diagnosis of CSU (EAACI), characterized by erythematous skin wheals accompanied by itching of unknown etiology will be recruited.
- •Eligible patients should demonstrate Symptom score of ≥2 (i.e. moderate to severe intensity UAS7 scores) during the baseline visit.
- •Patients willing to give informed consent will be included.
排除标准
- •Patients excluded from the study if they have any dermatological condition that could interfere with the efficacy evaluation (including eczema, contact dermatitis, atopic dermatitis, nummular eczema, autosensitization dermatitis, asteatotic eczema, lichen simplex chronicus, angioedema, , urticaria with known causes, urticaria related to thyroid disorders, urticaria pigmentosa, psoriasis, or ichthyosis o Known hypersensitivity to antihistamine, oKnown autoimmune disorders, Hodgkins disease oAny clinically significant condition (cardiovascular, neurological, hepatic, renal, or malignant diseases), oReceived ultraviolet light therapy before entry.
- •oSimilarly, patients who had received antihistamines (including H2 receptor antagonists) within 3 days, nonsteroidal anti-inflammatory drugs within 3 days, topical or systemic steroids within 4 weeks, astemizole within 6 weeks, ketotifen within 2 weeks, anti-Leukotrienes within 3 days.
- •oPregnant and lactating women.
- •oSubject who is currently enrolled in another investigational drug study.
结局指标
主要结局
It is the change from baseline in mean weekly Urticaria activity score-7( i.e the sum of the daily UAS i.e.(sum of wheal & itching day and night time score) self evaluation scores of 7 individual days,which could range between 0 to 42 per week) after 4 weeks of treatment
时间窗: five time points-patients will be analyased during baseline and after every 7 days for 4 weeks
次要结局
- Time to onset of action will be determined by comparing Bepotastine besilate with Levocetrizine by using participant’s daily scoring chart.(C-reactive protein and Absolute Eosinophil count will be evaluated during the baseline visit and end of therapy for predicting the outcome of treatment with Bepotastine. 2.Chronic Urticaria quality of life questionnaire)
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
不适用
A Clinical Study to compare the Efficacy of Nashtapushpantaka Rasa and Rajahpravartini Vati in the treatment of Artavakshaya in females of Polycystic Ovarian SyndromeCTRI/2025/04/084467Mamta Rani134
招募中
4 期
A study comparing vilazodone with escitalopram in terms of efficacy , safety and onset of action in patients with depression.CTRI/2019/01/017302Dr Ankushe rohini92
尚未招募
2/3 期
A trial is to see durvadi ghrita and karanjadi ghrita are effective or noneffective in an infected woundCTRI/2023/04/052029Aniket Anil Bobade80
尚未招募
2 期
A clinical trial to evaluate and compare the effect of Tulsi capsules alone and along with guided imagery meditation in professional students suffering from Adjustment disorderCTRI/2025/04/08487630
尚未招募
3 期
Safety and Efficacy of DIDALA Monotherapy in Patients With Type 2 Diabetes Compared With Metformin.Type 2 DiabetesNCT05760456Centre of Clinical Pharmacology, Hanoi Medical University140