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
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
- To assess the change or improvement in SNOT -20 (Sino Nasal Outcome Test)
研究概览
简要总结
Sinusitis is a common inflammation of theparanasal sinuses, the cavities that produce the mucus necessary for the nasalpassages to work effectively.
It can be acute orchronic, and it can be caused by viruses, bacteria, fungi, allergies, or evenan autoimmune reaction.
Sinusitis is an inflammation of your sinuses. Your sinuses are thehollow passages in the bones surrounding your nose. They produce mucus to keepyour nasal passages moist, and they drain into your nasal cavity.
Infections are a common cause of sinusitis. Infections can develop ifthe passages that drain into your nose get blocked or plugged. If you havesinusitis you may feel pressure in your sinuses and have mucus drainage in theback of the throat, called postnasal drip
Allergic rhinitis is a diagnosisassociated with a group of symptoms affecting the nose. These symptoms occurwhen you breathe in something you are allergic to, such as dust, animal dander,or pollen. Symptoms can also occur when you eat a food that you are allergicto.
Study Rational : The clinical study is being conducted to evaluateextended efficacy and safety of Sinuset Tablets.
Study Design: Aprospective, multicenter, double blind, placebo controlled randomized clinicaltrial to evaluate efficacy and safety of Sinuset tablets in patients suffering from Sinusitisand/or Allergic Rhinitis
A prospective,multicenter, double blind, placebo controlled randomized clinical trial.Study Population:Subjects suffering from Acute or Chronic Sinusitis and/or AllergicRhinitis
Study Treatment:Investigational products-
1. Sinuset tablets to be taken 2tablets three times a day
2. Placebo
Dosage - 2tablets to be taken thrice daily, for 14 days
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 12.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
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 investigator’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 Smokers 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.
结局指标
主要结局
To assess the change or improvement in SNOT -20 (Sino Nasal Outcome Test)
时间窗: Day 0 to Day 14
次要结局
- Safety and tolerability of the study drug(s) will be assessed by the(Clinical AEs occurring during entire duration of study)