Tonsilotren® in chronic tonsillitis
- Conditions
- Chronic tonsillitisRespiratory
- Registration Number
- ISRCTN19016626
- Lead Sponsor
- Deutsche Homöopathie-Union DHU-Arzneimittel GmbH & Co. KG (Germany)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 240
1. Subjects aged 6 to 60 years, either sex
2. Diagnosis of chronic tonsillitis
3. Written informed consent
4. Willingness and ability to comply with all trial procedures
1. Presence of acute throat infection at inclusion
2. Presence of peri-tonsillar abscess
3. Presence of acute and chronic otitis, adenoiditis, sinusitis of all types, odontological infection, bronchial and lung disease, tuberculosis or known allergic manifestations in the throat and / or mouth
4. Obstruction in the pharynx due to enlargement of tonsils
5. Presence of severe cardiovascular, renal or hepatic disease, as well as gastroesophageal reflux, unstable diabetes mellitus, hyperthyroidism, cerebrovascular or other active bleeding, human immunodeficiency virus infection, mononucleosis of each severity, or oropharyngeal gonorrhea
6. History of non-steroidal anti-inflammatory drugs (NSAIDs) intolerance, hematogenetic dysfunction of unknown origin, repeated peptic ulcera or hemorrhages
7. History or presence of all kind of serious streptococcal complications
8. Previous surgery in the past six months or need for surgery of the nose or paranasal sinuses, adenoids and/or tonsils
9. Evidence of any malignant disease during the past five years before enrolment into the trial
10. Presence of neurological and/or psychiatric diseases interfering with evaluation of quality of life and assessment in the patient's diary
11. Treatment with systemic acting antibiotics, glucocorticosteroids or medications with immunomodulating activities during the past four weeks and treatment with NSAIDs as well as locally on the tonsils acting antibiotics, glucocorticosteroids or immuno-modulators during the past week prior to enrolment into the trial
12. Known or suspected hypersensitivity to chromium, mercury or any other ingredient and/or excipient of Tonsilotren, lactose and / or fructose intolerance and known intolerance towards leather and jewelry metals as well as towards dental metal fillings and vaccines;
13. Heavy smoking or known or suspicion to or presence of drug addiction including alcohol abuse
14. Women of childbearing potential without adequate contraception or women, who want to become pregnant, are pregnant or breastfeeding
15. Prior enrolment into this trial
16. Participation in another clinical trial during the past three months prior to enrolment into the trial
17. Incapability of understanding nature, meaning and consequences of the trial
18. Patients in custody by juridical or official order
19. Patients, who are members of the staff of the study center, staff of the sponsor or involved Clinical Research Organizations, the investigator him- / herself or close relatives of the investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean period of time between consecutive acute throat infections within one year
- Secondary Outcome Measures
Name Time Method