ISRCTN14067635已完成未知
Assessment of the tolerance and efficacy of Stérimar Stop & Protect Rhume/Cold - randomized, double-blind, controlled versus Stérimar Hypertonic parallel-group, non-inferiority clinical study
Church & Dwight (United States)0 个研究点目标入组 102 人开始时间: 2021年3月18日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 102
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
- 性别
- All
入选标准
- •1. Symptoms of common cold
- •2. Aged from 18 to 60 years
排除标准
- •1. Patients with symptoms started > 48 hours before enrolment.
- •2. Patients presenting an oral temperature greater than 38.9°C.
- •3. Patients with positive results on a streptococcal antigen screening test.
- •4. Patients with signs of lower respiratory tract disease.
- •5. Patients with history of allergic (seasonal or perennial) rhinitis or reporting sneezing or itching of the nose or eyes at the time of enrolment.
- •6. Patients with history of asthma or reporting cough, wheezing or shortness of breath at the time of enrolment.
- •7. Patients with current or reporting history of recurrent bronchitis, otitis or pharyngitis.
- •8. Patients with recent or current sinus infection (diagnosed by a physician in the past 30 days) or reporting history of recurrent sinusitis (more than two per years).
- •9. Patient with immune system disorder (autoimmune and immune deficiency disease such as SLE or AIDS).
- •10. Patients with a clinical significant cardiovascular, endocrine, neurological, respiratory, or any other current disease considered by the Investigator as an exclusion criterion, e.g. chronic respiratory or lung disease or chronic obstructive pulmonary disease (COPD).
- •11. Patients with severe nasal septum deviation or other current condition that can cause nasal obstruction, such as nasal polyps or nasal / sinus surgery in the past, able to influence symptoms scores.
- •12. Pregnant women.
- •13. Patients using saline nose drops or nasal sprays or pumps other than the study products, antibiotics, antivirals, nasal or systemic steroids, nonsteroidal anti-inflammatory drugs (NSAIDs), intranasal medicines, decongestants, antihistamines, combination cold formulae, Echinacea, supplements containing = 10 mg zinc or = 100 mg vitamin C, i.e. using OTC or prescribed medication (other than for contraception) able to influence symptoms scores at the time of enrolment.
- •14. Patients with known hypersensitivity or allergy to any component of the study medication or of the rescue medication (acetaminophen).
- •15. Patients smoking during the past 12 months.
- •16. Patients with a history of alcohol or drug abuse.
- •17. Patients participating to any investigational drug trial within 4 weeks before screening.
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