CTRI/2020/08/027125招募中4 期
A Post Market Surveillance study of Fixed Dose combination of Levocetrizine Hydrochloride 5 mg and Montelukast 10mg in patients with Seasonal Allergic Rhinitis - FI_AR_001_19
试验速览
- 阶段
- 4 期
- 状态
- 招募中
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
- •Willing and able to sign informed consent form. Written informed consent must be obtained before any assessment is performed • Patients with history of SAR prior to the study • Patients who agree to maintain consistency in their surroundings throughout the study period. • Were patients from outpatient department of ENT and general physician between the age group of 18â??65 years of either gender having moderate-severe intermittent or mild persistent AR according to original ARIA classification. • The study inclusion criteria required the patients with total nasal symptom score (TNSS) of 5 or higher, not treated with antihistaminics in the previous week.
排除标准
- •Hypersensitivity to Levocetirizine Hydrochloride 5 mg and Montelukast 10 mg or any excipients • Patients with upper respiratory tract infection or acute/chronic pulmonary disorder • Patients also with non-allergic rhinitis with different causes. • Patients with severe asthma. • Presence of nasal polyps or any clinically important nasal anomaly. • History of acute/chronic sinusitis within 30 days of Visit 1 • History of intranasal / eye surgeries within 3 months of Visit 1 • Initiation of immunotherapy or dose modification within 1 month prior to Visit 1 • Have presence of any condition that in the opinion of the physician places the patient at undue risk or potentially jeopardizes the quality of data to be generated. • Patient requiring other anti- histamine, corticosteroids (oral and/parenteral), immunotherapy, cromolyn sodium, nedocromil and inhaled cholinergics, oral or long acting beta-agonist, theophylline, tricyclic antidepressants, other leukotriene modifiers and bronchodilators, etc that may affect the efficacy of study drug are not enrolled in the study. • Decongestants, anti-inflammatory medicines and other rescue medicines for allergic rhinitis are not permitted during the study. • Should not be suffering from any other psychiatric illness or any other chronic disease which would interfere with trial assessments. • Known contraindication for the use of Levocetirizine Hydrochloride and Montelukast • A history of drug or alcohol abuse within the past 6 months • Currently participating (or participated within the previous 30 days) in an investigational therapeutic or device study • Female who is pregnant, nursing, or of child-bearing potential.
研究者
相似试验
进行中（未招募）
不适用
Follow-up survey for comparing stable dosing with a symptom based as needed-regimen” in moderate and severe persitent asthma.Moderate and severe persistent asthma.MedDRA version: 9.1Level: LLTClassification code 10003553Term: AsthmaEUCTR2008-006768-13-SEGlaxoSmithKline AB
尚未招募
不适用
The observational Post-Market Clinical Follow-up activity with the dialysis catheters P-DLS from Joline GmbH & Co.KG.N17N18Acute renal failureChronic kidney diseaseDRKS00030687Joline GmbH & Co. KG115
招募中
不适用
A post market clinical follow-up study with the aneXys ceramys inlay DEM16.7M16.1Other secondary coxarthrosisOther primary coxarthrosisDRKS00018809Mathys Orthopädie GmbH150
已完成
不适用
A post market clinical follow-up study with the aneXys acetabular cup and ceramys inlayM16.1M16.7Other primary coxarthrosisOther secondary coxarthrosisDRKS00021508Mathys AG Bettlach150
尚未招募
4 期
Clinical Investigation of Non-Absorbable Sutures, Skin Stapler and Catridge in surgery for skin closure.CTRI/2022/01/039306Futura Surgicare Pvt Ltd