CTRI/2021/02/031161已完成未知
Prospective, Single Arm, Investigator Initiated Study to Evaluate Efficacy and safety of Bilazest (Bilastine 20mg) Tablets in Adult Patients with Allergic Rhinitis
I0 个研究点目标入组 90 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •1. Patient willing and able to sign informed consent form.
- •2. Male & female patient between age group 18 years - 60 years
- •3. Patient with clinical history and presenting symptoms of Allergic Rhinitis who have not taken any medications for at least 2 weeks
- •4. Patient with no allergies to any of the ingredients of the study drug as per PI’s discretion
- •5. Patient willing to follow the protocols requirements
排除标准
- •1. Patient having hypersensitivity to Bilastine or any excipients of IP as per PI’s discretion
- •2. Patient with nasal polyps and deviation of the nasal septum or significant nasal tract structural malformation
- •3. Patient taking H1 or H2 antihistamines within 3 days to one week
- •4. Patient with acute or chronic sinusitis within 30 days of visit 1
- •5. Patient with a history of hypersensitivity to antihistamines, imidazole’s or lactose.
- •6. Patient taking corticosteroids during the last 4 weeks; loratadine or desloratadine during the last 10 days; anti-leukotrienes or ketotifen during the last 2 weeks; macrolides, imidazole, anticholinergics or decongestants during the last 3days; or immunotherapy within 2 years (unless taking a stable maintenance dose for 1 month) before entry into the study, any CNS acting agents including antidepressants,sedatives,anxiolytic,hypnotics, opioids or neuroleptics at any time
- •7. Patient with a history of alcohol and drug abuse
- •8. Patient with a history of smoking or tobacco use
- •9. Patient with any clinically significant condition (cardiovascular, neurological, upper
- •respiratory tract infection or acute/chronic pulmonary disorder, severe asthma or
- •malignant diseases)
- •10. Pregnant or nursing women
- •11. Patient who had participated in another trial within the previous 3 months
- •12. Patient with non-allergic rhinitis with different causes.
- •13. History of intranasal / eye surgeries within 3 months of Visit 1
- •14. Patient suffering from any other psychiatric illness or any other chronic disease which would interfere with trail assessments as per PI’s discretion
研究者
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