CTRI/2021/02/031045已完成3 期
A prospective, multicenter, double blind, placebo controlled randomized clinical trial to evaluate efficacy and safety of Sinuset tablets in patients suffering from Sinusitis and/or Allergic Rhinitis - CT-IR-AR- 2020
BHARGAVA PHYTOLAB0 个研究点目标入组 100 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Subject is willing and able to give written informed consent.
- •Patients of either sex aged between 18 to 65 years
- •Subject having clinical diagnosis as per investigatorâ??s judgment for Acute or Chronic Sinusitis and/or Allergic Rhinitis.
- •Subjects of childbearing potential should have a negative Pregnancy test at Screening.
- •Female subjects of childbearing potential should be willing to practice appropriate birth control during the entire duration of the study.
- •Appropriate birth control is defined in the study as any medically recommended method (or combination of methods) except oral birth control pills as per standard of care.
- •Subject is willing, able and likely to comply with all study procedures and restrictions.
排除标准
- •Patients who are suspicious or diagnosed for pneumonia
- •Patients with chronic bronchitis, Chronic Obstructive Pulmonary Disease (COPD), bronchiolitis, asthma, bronchial asthma or other LRTI
- •Patients with Deviated Nasal Septum
- •Patients with active infection who needs administration of antibiotics
- •Patients with myocardial infarction, congestive heart failure
- •Patients with renal disorder or liver disorder
- •Patients with hypotension or hypertension
- •Patients with history of epilepsy
- •Patients with hyperthyroidism
- •Patients with gastroduodenal ulcer
- •Patients with severe hypoxemia
- •Patients who are in drug or therapy or planned to have- Antibiotics, anti-virus, and systemic or inhalation glucocorticosteroids: from 2 weeks prior to administration of investigational product to termination of clinical trial
- •Secretolytics/mucolytics, expectorants, antitussives, herbal medicines which has antitussive or expectorant effect: from 2 days prior to administration of investigational product to termination of clinical trial
- •Analgesics except acetaminophen, antihistamines, β2-agonists, bronchodilators which includes anticholinergic agents, xanthine derivatives, central nervous system stimulants, drug which is known for interaction between acebrophylline (cimetidine, alloprinol, oral anticoagulants, furosemide, reserpine, barbiturates, phenytoin) and symptomatic therapy for other therapy for acute bronchitis: whole period for clinical trial
- •Patients who have history for drug hypersensitivity or allergic reaction in component of investigational product or similar drug
- •Patients who are pregnant and/or breast feeding.
- •Patients with no intention to use appropriate contraceptives or has a plan to become pregnant
- •Patients who had an administration of other investigational product or medical device for clinical trial 4 weeks prior to participation of clinical trial
研究者
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