Evaluation of the Efficacy and Safety of Rupatadine & Loratadine in Chronic Idiopathic Urticaria - A Randomized Single-Blind Comparative Clinical Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Improves Total Symptom score(TSS)
研究概览
简要总结
PURPOSE:
It is part of MD thesis proposal
BACKGROUND:
· Urticaria is a transient vascular reaction pattern characterized by circumscribed, edematous, itchy lesions, usually lasting for a few hours to one or two days.
· In particular, chronic urticaria is characterized by the occurrence of wheals daily or almost daily for a period of at least six weeks, with an estimated lifetime prevalence of 0.5% across all populations studied.
· Although individually Loratadine and Rupatadine are efficacious for CIU, unique findings in some studies indicate a likelihood of differences between these two drugs.
· Its pathogenesis involves mainly histamine and also other mediators, including platelet-activating factor (PAF) and tumor necrosis factor-α (TNFα). In the absence of an exact etiology, H1 -antihistaminics are the mainstay of treatment. Loratadine is widely prescribed for CIU.
· Rupatadine, a newer antihistaminic, has PAF receptor antagonist activity and has shown anti-TNF-α activity in vitro. These additional anti-inflammatory effects may improve its efficacy.
· Therefore, this study has been conducted to compare the therapeutic efficacy and tolerability of Rupatadine and Loratadine in patients suffering from CIU.
· The relative absence of data in this domain is an incentive to further explore the aspect of the disease.
AIM:
To Compare the Efficacy and Safety of Loratadine and Rupatadine in patients with Chronic Idiopathic Urticaria.
OBJECTIVES:
1. To evaluate whether Rupatadine improves Total Symptom score(TSS) in CIU in comparision with Loratadine.
2. To evaluate whether Rupatadine improves Dermatology Life Quality Index(DLQI) compared with Loratadine.
3. To evaluate whether Rupatidine improve Global Efficacy Score compare to Loratadine.
4. To evaluate safety of Rupatadine by Observing Adverse drug reaction by Visual Analogue scale compare to Loratadine.
STUDY DESIGN:
1.Prospective and Interventional Study.
2.Randomized Single - Blind Study.
3.The Total Sample Size of 60(30 subjects in each group).
MODE OF SELECTION OF SUBJECTS:
Randomized Selection Pattern
METHODOLOGY:
It will be Prospective,Interventional and comparative study comprising of 60 subjects with Chronic Idiopathic Urticaria patients at SRM MCH & RC. Based on Inclusion and Exclusion Criteria subjects will be grouped into two. Subjects who received Loratadine 10mg once dailyconsidered Group 1 and Rupatadine 10mgonce daily considered Group 2.Both group consists of 30 subjects in Each. Subjects will be followed up to 6 weeks.
Data collection:
Data will be collected from the patient’s case sheet and will be entered in patient Proforma after obtaining permission from the Head of the department, Dermatology.
The Parameters are:
-
Demographics Profile: Age, Gender, BMI
-
Past Medical History, Family History, Personal History
3.Blood Pressure
- Blood Investigation: Total Leucocyte Count, DC Neutrophil,
DC Lymphocyte, DC Eosinophil, Absolute Eosinophil Count.
-
Adverse Reactions:
-
Time for Symptom Relief:
7.Total Symptom Score(TSS), Dermatology Life Quality Index(DLQI),Global Efficacy Score(GES).
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Man or woman aged between 18 to 65yrs old.
- •2.Documented history of active CIU (urticaria wheals) for at least three days per week over the last 6 weeks.
- •3.Active CIU(labeled as moderate pruritus) for at least 3 days (not necessarily consecutive days) in the week before inclusion with a total score of active CIU labeled as at least a moderate severity of pruritus (score≥2) for these 3 days.
- •4.Those who were willing to participate in the study and comply with its procedures by signing a written informed consent.
排除标准
- •1.Patients suffering from other forms of urticaria, with significant concomitant illness (e.g., malignancies or hepatic, psychiatric, endocrine or other major systemic diseases).
- •2.Pregnant women, lactating mothers, females on oral contraceptive pills.
- •3.Patients on antihistaminic therapy for 72 hours, or steroids for one month, were excluded from the study.
- •4.Patients with Drug Allergy.
结局指标
主要结局
Improves Total Symptom score(TSS)
时间窗: At the end of 6 weeks
次要结局
- Improves Dermatology Life Quality Index(DLQI),(Improve Global Efficacy Score,)