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| [ Print-friendly version ] |
| Tonsilotren® in chronic Tonsillitis |
| ISRCTN | ISRCTN19016626 |
| DOI | 10.1186/ISRCTN19016626 |
| ClinicalTrials.gov identifier | |
| EudraCT number | 2012-001430-34 |
| Public title | Tonsilotren® in chronic Tonsillitis |
| Scientific title | Therapeutic effectiveness, safety and tolerability of Tonsilotren® tablets in patients (6 to 60 years old) with chronic tonsillitis |
| Acronym | TocTo |
| Serial number at source | 10-TT-EP-003 |
| Study hypothesis | No formal study hypothesis has been formulated. The data will be analyzed exploratively. The actual study has been set up to obtain systematically data of Tonsilotren® when treating patients suffering from chronic tonsillitis with Tonsilotren® under conditions which are as close as possible to normal daily routine. |
| Lay summary |
Background and study aims
Chronic tonsillitis is a permanent inflammation of the tonsils. It means recurrent acute throat infections as well as swallowing problems, sore throat and/or bad breath which may come and go. In case of acute throat infections, patients usually receive pain relief medicines and/or antibiotics. Tonsilotren is a homeopathic medicinal product which is traditionally used for tonsillitis. The aim of this study is to assess how well Tonsilotren works in patients with chronic tonsillitis. The effect of Tonsilotren tablets will be assessed when they are given in addition to conventional treatment. Who can participate? 240 patients with chronic tonsillitis in Germany, Spain and Ukraine will be allowed to participate to this study. They will be between 6 and 60 years, of either gender. What does the study involve? Al patients will receive conventional treatment which the study doctors will adjust to the clinical symptoms of the patients. In addition, one in two patients (the selection will be done at random) will also receive Tonsilotren. Patients will see their study doctor 9 times in total over 14 months. At each of the visits, the study doctor will perform a thorough physical examination (chronic tonsillitis-specific symptoms as well as respiratory complaints when present). Patients will have to take their conventional medication as agreed with the study doctor. The patients belonging to the Tonsilotren group will also have to take Tonsilotren according to a fixed dosage scheme. Patients will have to keep a diary to record the evolution of their chronic tonsillitis symptoms. In between the visits the study doctors will call the patients to check their medical condition. What are the possible benefits and risks of participating? Patients will receive a conventional symptomatic treatment for their chronic tonsillitis which does not differ from the treatment they would receive if they did not participate in this study. If patients are in the Tonsilotren group, they will receive the homeopathic medicinal product Tonsilotren which is usually well tolerated. Possible side effects of Tonsilotren include reactions of hypersensitivity like skin rashes or possibility of increased salivation. At the beginning of this clinical study, patients will receive a detailed diagnostic evaluation and will be under close medical supervision for as long as the study continues. By participating in this study, patients might contribute to new scientific findings relevant to the treatment of chronic tonsillitis with Tonsilotren. Where is the study run from? The study will be carried out by private practices or medical institutions experienced in ear-nose-throat medicine in Germany, Spain and Ukraine. When is the study starting and how long is it expected to run for? Recruitment is expected to start by 30 January 2013 and last for 14 months. Individual study duration for each patient will be 14 months. Who is funding the study? The study is funded by Deutsche Homöopathie-Union, DHU-Arzneimittel GmbH & Co. KG, Ottostraße 24, D-76227 Karlsruhe. Who is the main contact? Dr Jürgen Palm dr.palm@onlinemed.de |
| Ethics approval |
1. Germany:
The Ethics Committee of the Bavarian State Medical Association (Ethikkommission der Bayrischen Landesärztekammer) approved on the 27th of August 2012 (ref: 12051). 2. Spain: The Ethics Committee of the Joined Foundation of the Catalanian Hospitals (Comité Ético de Investigación Clínica de la Fundació unio catalana d’hospitals) approved on 16th of October 2012. 3. Ukraine: Local Ethics Committee from the National children’s specialized hospital Ohmatdyt (Kiev) approved on 29th of August 2012 (ref: 48) Local Ethics Committee from the Vinnytsia Regional Clinical Hospital approved on 30th of July 2012 (ref: 01-5-02/5) Local Ethics Committee from the Poltava Regional Clinical Hospital approved on 2nd of November 2012 (ref: 47) Local Ethics Committee from the Odessa National Medical University approved on 11th of September, 2012 (ref: 1) Local Ethics Committee from the Lugansk Hospital of Ministry of Internal Affairs approved on 16th of July 2012 (ref: 1) Local Ethics Committee from the Lugansk Regional Children’s Clinical Hospital approved on 26th of July 2012 (ref: 1) |
| Study design | Randomized international multicenter open controlled clinical trial |
| Countries of recruitment | Germany, Spain, Ukraine |
| Disease/condition/study domain | Patients suffering from chronic tonsillitis |
| Participants - inclusion criteria |
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 |
| Participants - exclusion criteria |
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 breast-feeding 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 |
| Anticipated start date | 30/01/2013 |
| Anticipated end date | 30/05/2015 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 240 |
| Interventions | Patients will be observed for 60 weeks. During that time they will receive three treatment cycles with Tonsilotren® each lasting eight weeks, in case the subject will be randomly allocated to the test-group. Additionally all study subjects (test as well as control group) receive a symptomatic treatment where needed. |
| Primary outcome measure(s) | Mean period of time between consecutive acute throat infections within one year |
| Secondary outcome measure(s) |
1. Number of days with either sore throat / difficulties in swallowing or halitosis or exhaustion [measurement: documentation in patient's diary]
2. Number of upper respiratory tract infections [measurement: documentation of investigator] 3. Severity of chronic tonsillitis symptoms [measurement: documentation of investigator using a 3-item scale: absent, mild, severe] 4. Frequency of antibiotics consumption due to acute throat infections [measurement: documentation of investigator] 5. Days with analgetics consumption due to acute throat infections [measurement: documentation in patient's diary] 6. Effect of treatment on performance of normal daily activity [measurement: documentation in patient's diary] 7. Patient’s quality of life [measurement: documentation on 5-item scale: very good, god, moderate, poor, very poor ] 8. Treatment outcome according to Integrative Medicine Outcome Scale [measurement: documentation of investigator and patient on 5-item scale: complete recovery, major improvement, slight to moderate improvement, no change, deterioration] 9. Tolerability of treatment [measurement: documentation of investigator and patient on 5-item scale: very good, god, moderate, poor, very poor] 10. Adverse events. [measurement: documentation of investigator] |
| Sources of funding | Deutsche Homöopathie-Union (DHU)-Arzneimittel GmbH & Co. KG (Germany) |
| Trial website | |
| Publications | |
| Contact name | Dr Juergen Palm |
| Address | Rueckersdorfer Str. 61 |
| City/town | Roethenbach an der Pegnitz |
| Zip/Postcode | D-90552 |
| Country | Germany |
| Sponsor | Deutsche Homöopathie-Union DHU-Arzneimittel GmbH & Co. KG (Germany) |
| Address | Ottostraße 24 |
| City/town | Karlsruhe |
| Zip/Postcode | D-76227 |
| Country | Germany |
| Sponsor website: | http://www.dhu.com |
| Date applied | 09/01/2013 |
| Last edited | 23/01/2013 |
| Date ISRCTN assigned | 23/01/2013 |
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