Treatment of acute tonsillo-pharyngitis or exacerbation of chronic tonsillopharyngitis and evaluation of local immunity parameters in adults Respiratory Tonsillopharyngitis
Conditions
Interventions
Study Treatments: Tonsilgon N arm - Tonsilgon N 25 drops every 2 hrs for the first 3 days of treatment then 25 drops TID till day 7.
Herbal lozenges arm – 1 pastil every 2 hrs for the
Sponsors
Central State Medical Academy
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Tonsillopharyngitis severity: TSS (Tonsillopharyngitis Severity Score) score at day 0 and day 4 TSS scale version of contract research organization Appletree AG was adapted for purposes of current study. TSS is a questionnaire for evaluation of presence and severity of following symptoms: throat pain, difficulty to swallow, salivation, pharynx mucosa hyperemia, hyperthermia by 4-point scale. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of patients achieved clinically significant improvement (TSS score = 5) at study day 4 2. Severity of pain or discomfort in throat by TSS subscale – proportion of patients with every grade of severity at baseline and day 4 3. Time until complete resolution of every symptom evaluated by patients' diary 4. Proportion (%) of patients completely recovered by day 4 (disease outcome by objective evaluation of Study Doctor) 5. Dynamic of every tonsillopharyngitis symptom severity by 4-point scale (0 to 3) at visit 2 compared to visit 1 6. Dynamic of every tonsillopharyngitis symptom severity by 4-point scale (0 to 3) at visit 3 compared to visit 1 7. Dynamic of local immunity markers (SIgA, TNF, IFN-a, lysozyme, lactoferrin, IL-1, -6, -8, -10, and-17) in mucosa of tonsils and back pharynx at visit 2 compared to visit 1 8. Dynamic of local immunity markers (SIgA, TNF, IFN-a, lysozyme, lactoferrin, IL-1, -6, -8, -10, and-17) in mucosa of tonsils and back pharynx at visit 3 compared to visit 1 9. Dynamic of local immunity markers (SIgA, TNF, IFN-a, lysozyme, lactoferrin, IL-1, -6, -8, -10, and-17) in mucosa of tonsils and back pharynx at visit 4 compared to visit 1 10. Proportion of patients (%), in which contents of local immunity markers (SIgA, TNF, IFN-a, lysozyme, lactoferrin, IL-1, -6, -8, -10, and-17) in mucosa of tonsils and back pharynx at visit 2 was equivalent to values in healthy persons (if deviation was detected at visit 1) 11. Proportion of patients (%), in which contents of local immunity markers (SIgA, TNF, IFN-a, lysozyme, lactoferrin, IL-1, -6, -8, -10, and-17) in mucosa of tonsils and back pharynx at visit 3 was equivalent to values in healthy persons (if deviation was detected at visit 1) 12. Proportion of patients (%), in which contents of local immunity markers (SIgA, | — |
Countries
Russian Federation
Contacts
Public ContactElena Savlevich
Outcome results
None listed