ISRCTN80067058已完成未知
Evaluation of anti-inflammatory properties of herbal medicines in patients with tonsillopharyngitis – interventional, open, randomized, one center comparative trial in parallel groups.
Central State Medical Academy0 个研究点目标入组 70 人开始时间: 2021年5月25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
- 70
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. Males and females aged 18 to 55 (inclusive)
- •2. Diagnosis at inclusion – mild acute tonsillopharyngitis” or chronic tonsillopharyngitis exacerbation”
- •3. Body temperature measured in armpit = 37.5°C
- •4. Tonsillopharyngitis severity by TSS = 8 points
- •5. Time from first symptoms’ onset until visit to physician – not more than 24 hours
- •6. Signed informed consent form
- •7. For females with childbearing potential and males – consent to use effective method of contraception across all study and following 1 month after its completion
排除标准
- •1. Any signs and symptoms of bacterial (streptococcal) tonsillopharyngitis (McIsaac scale score > 1)
- •2. Positive result of express-test Streptatest
- •3. Consumption of antibiotics during < 48 hours prior to inclusion
- •4. Patients earlier received tonsillectomy or tonsillotomy
- •5. Use of local treatments for oropharyngeal disease (aerosols, gargle solutions, tablets/orodispersible tablets/lozenges) during 24 hours prior to inclusion and/or impossibility to discontinue use of any local treatments, except used in study, during study course
- •6. Use of systemic, inhaled or nasal glucocorticosteroids during 30 days prior to study start, injectable corticosteroids – during 3 months prior to study start and/or plans to use glucocorticosteroids (except topical dermal ones) during the course of study
- •7. Impossibility to withdraw for study period any medicinal preparations that could influence result of current study, e.g., antiviral medicines, or preparations incompatible with study treatments (see Section Prohibited concomitant therapies”)
- •8. Pharyngitis granulosa
- •9. Signs of fungal oropharyngeal infection (white caseous plaques easy removable by pallet)
- •10. Clinical signs of diphtheria
- •11. Presence of signs of sinusitis, otitis, eustachitis, laryngitis, tracheitis, bronchitis (since indicated conditions could demand indication of medicines, that could possibly affect evaluation of study results; it is acceptable to include patients with rhinitis with use of therapies permitted by the Protocol)
- •12. Vaccination of patient conducted in 30 days prior to inclusion
- •13. Assumed low patients’ compliance with treatment or inability to undergo procedures and follow restrictions according to study protocol (e.g., as a result of psychiatric disorders)
- •14. Clinically meaningful deviations of blood count, including any of the following signs: leukocytosis > 9?10^9/L, neutrophilia >78%, band neutrophil content >6% or presence of younger neutrophil forms, erythrocyte sedimentation rate >30 mm/h
- •15. Liver diseases
- •16. History of craniocerebral injury
- •17. Brain diseases
- •18. Any cardiovascular, kidney, liver, gastrointestinal (GI), endocrine, and nervous system diseases or any other diseases/conditions that, by Study Doctor’s opinion, could lead to unsafety of patients participation in the study
- •19. Any concomitant diseases that require use of medications influencing immune system (immune system modulators, stimulators, suppressors) or antibiotics
- •20. Need to use medications that act through ?-aminobutyric acid receptors (e.g., barbiturates and benzodiazepines)
- •21. Pregnant, lactating women or women planning pregnancy during next two months;
- •22. Women of reproductive age, that did not confirm use of highly effective contraception methods (combined oral contraceptives, double barrier method)
- •23. Misuse of alcohol, or use of other psychoactive substances
- •24. Known hypersensitivity for any component of Tonsilgon N (chamomile, althea, oak bark, taraxacum, horsetail, walnut, milfoil, plants of Compositae family) or salvia and other related herbs (Asteraceae family)
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