Comparison of Tonsilgon N and local herbal anti-inflammatory medicine in patients with tonsillitis

Not Applicable

Completed

• Conditions: Respiratory; Treatment of acute tonsillo-pharyngitis or exacerbation of chronic tonsillopharyngitis and evaluation of local immunity parameters in adults; Tonsillopharyngitis

• Registration Number: ISRCTN80067058
• Lead Sponsor: Central State Medical Academy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-12-31
• Study Start: 2021-05-25
• Last Update Posted: 19 September 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 70

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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified