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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-016682-28 | EudraCT Number |
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The purpose of this study is to determine whether the dry extract BNO 1016 is effective and safe in the treatment of acute rhinosinusitis in adults.
The aim of this clinical study is to investigate the efficacy of a 15-days treatment with the herbal medicinal product BNO 1016 for therapy of acute rhinosinusitis in adult patients. Due to the considerable morbidity and the diminished quality of life experienced by people afflicted with acute rhinosinusitis an important aim of the treatment is to reduce the severity of rhinosinusitis symptoms and the duration of the disease. By grading the severity of the disease on the basis of the 5 main rhinosinusitis symptoms the investigator will assess the efficacy of the treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BNO 1016 | Experimental | sugar coated tablets with dry extract (80 mg) of 5 herbal drugs; dosage: 480 mg per day (2 tablets t.i.d.) duration: 15 days |
|
| Placebo | Placebo Comparator | sugar coated tablets with identical appearance to active treatment; frequency: 2 tablets t.i.d. duration: 15 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BNO 1016 | Drug | sugar coated tablets with dry extract (80 mg) of 5 herbal drugs; dosage: 480 mg per day (2 tablets t.i.d.) duration: 15 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Major Symptom Score (MSS) Assessed by the Investigator | MSS: sum of the 5 main rhinosinusitis symptoms which are: rhinorrhea (anterior discharge), postnasal drip, nasal congestion, headache, facial pain/pressure. Each symptom is individually evaluated using the following 4-point rating scale (scoring system): 0 = none/not present, 1 = mild, 2 = moderate, 3 = severe. Thus the MSS ranges from a minimum of 0 to a maximum of 15 score points. | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| SNOT 20 Symptom Scores | Sino-Nasal Outcome Test (SNOT 20): 20 item questionnaire to assess the symptoms and emotional and social consequences of rhinosinusitis. The symptoms are assessed by the patient using a 6-point rating scale: 0 = not present / no problem, 1 = very mild problem, 2 = mild or slight problem, 3 = moderate problem, 4 = severe problem, 5 = problem as "bad as it can be". range: 0 to 100 |
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Inclusion Criteria:
Diagnosis of acute rhinosinusitis
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rainer Jund, MD | Specialist in Otorhinolaryngology | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Rainer Jund, Specialist in Otorhinolaryngology | Puchheim | 82178 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23193534 | Derived | Jund R, Mondigler M, Steindl H, Stammer H, Stierna P, Bachert C; ARhiSi II study group. Clinical efficacy of a dry extract of five herbal drugs in acute viral rhinosinusitis. Rhinology. 2012 Dec;50(4):417-26. doi: 10.4193/Rhino.12.015. |
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January 2010 to April 2010 37 centres (16 ENT and 21 specialists in internal medicine and general practitioners
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| ID | Title | Description |
|---|---|---|
| FG000 | BNO 1016 | sugar coated tablets with dry extract (80 mg) of 5 herbal drugs; daily dose: 480 mg (2 tablets tid) |
| FG001 | Placebo | sugar coated tablets of identical appearance to active treatment |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | BNO 1016 | sugar coated tablets |
| BG001 | Placebo | sugar coated tablets |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Major Symptom Score (MSS) Assessed by the Investigator | MSS: sum of the 5 main rhinosinusitis symptoms which are: rhinorrhea (anterior discharge), postnasal drip, nasal congestion, headache, facial pain/pressure. Each symptom is individually evaluated using the following 4-point rating scale (scoring system): 0 = none/not present, 1 = mild, 2 = moderate, 3 = severe. Thus the MSS ranges from a minimum of 0 to a maximum of 15 score points. | FAS: randomised patients with at least one documented application of the drug and post-baseline efficacy data | Posted | Mean | Standard Error | units on a scale | 14 days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BNO 1016 | sugar coated tablets |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA 12.0 | Non-systematic Assessment |
Headache and facial pain are rated by investigator based on the description of the patient. This was done to ensure a uniform rating of symptom severity across the investigational sites but nevertheless subjective and open to error.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Rainer Jund, Specialist in Otorhinolaryngology | ENT practice | +49 89 804880 | RainerJund@gmx.de |
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| ID | Term |
|---|---|
| C578474 | BNO 1016 |
| C028353 | Sinupret |
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| Placebo | Drug | sugar coated tablets with identical appearance to active treatment; frequency: 2 tablets t.i.d. duration 15 days |
|
|
| 14 days |
| Major Symptom Score Assessed by the Patient | MSS: sum of the 5 main rhinosinusitis symptoms which are: rhinorrhea (anterior discharge), postnasal drip, nasal congestion, headache, facial pain/pressure. Each symptom is individually evaluated using the following 4-point rating scale (scoring system): 0 = none/not present, 1 = mild, 2 = moderate, 3 = severe. Thus the MSS ranges from a minimum of 0 to a maximum of 15 score points. | 14 days |
| Percentage of Patients Classified as Responders by the Investigator on a 4-point Rating Scale | General assessment of efficacy using a 4-point rating scale (symptoms healed, improved, unchanged, deteriorated). Patients whose symptoms are improved or healed will be classified as "responders" to treatment. Patients whose symptoms are unchanged or deteriorated as classified as "non-responders". | 14 days |
| Ultrasonography of Paranasal Sinuses | Percentage of patients with signs of acute rhinosinusitis in ultrasonography of paranasal sinuses will be evaluated. Ultrasonography scans will be visually evaluated by the investigator for signs of rhinosinusitis. | 14 days |
| Total |
Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
sugar coated tablets
|
|
| Secondary | SNOT 20 Symptom Scores | Sino-Nasal Outcome Test (SNOT 20): 20 item questionnaire to assess the symptoms and emotional and social consequences of rhinosinusitis. The symptoms are assessed by the patient using a 6-point rating scale: 0 = not present / no problem, 1 = very mild problem, 2 = mild or slight problem, 3 = moderate problem, 4 = severe problem, 5 = problem as "bad as it can be". range: 0 to 100 | FAS: randomised patients with at least one documented application of the drug and post-baseline efficacy data | Posted | Mean | Standard Deviation | units on a scale (range: 0 - 100) | 14 days |
|
|
|
| Secondary | Major Symptom Score Assessed by the Patient | MSS: sum of the 5 main rhinosinusitis symptoms which are: rhinorrhea (anterior discharge), postnasal drip, nasal congestion, headache, facial pain/pressure. Each symptom is individually evaluated using the following 4-point rating scale (scoring system): 0 = none/not present, 1 = mild, 2 = moderate, 3 = severe. Thus the MSS ranges from a minimum of 0 to a maximum of 15 score points. | FAS: randomised patients with at least one documented application of the drug and post-baseline efficacy data | Posted | Mean | Standard Error | units on a scale | 14 days |
|
|
|
| Secondary | Percentage of Patients Classified as Responders by the Investigator on a 4-point Rating Scale | General assessment of efficacy using a 4-point rating scale (symptoms healed, improved, unchanged, deteriorated). Patients whose symptoms are improved or healed will be classified as "responders" to treatment. Patients whose symptoms are unchanged or deteriorated as classified as "non-responders". | FAS: randomised patients with at least one documented application of the drug and post-baseline efficacy data | Posted | Number | percentage of patients | 14 days |
|
|
|
| Secondary | Ultrasonography of Paranasal Sinuses | Percentage of patients with signs of acute rhinosinusitis in ultrasonography of paranasal sinuses will be evaluated. Ultrasonography scans will be visually evaluated by the investigator for signs of rhinosinusitis. | FAS: randomised patients with at least one documented application of the drug and post-baseline efficacy data | Posted | Number | percentage of patients | 14 days |
|
|
|
| 0 |
| 194 |
| 19 |
| 194 |
| EG001 | Placebo | sugar coated tablets | 0 | 191 | 27 | 191 |
| Cerumen impaction | Ear and labyrinth disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Ear pain | Ear and labyrinth disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Tinnitus | Ear and labyrinth disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Eye discharge | Eye disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Abdominal upper pain | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Facial pain | General disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Hypersensitivity | Immune system disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
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| Furuncle | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
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| Laryngitis | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
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| Viral infection | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 12.0 | Non-systematic Assessment |
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| Injury | Injury, poisoning and procedural complications | MedDRA 12.0 | Non-systematic Assessment |
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| ASAT increased | Investigations | MedDRA 12.0 | Non-systematic Assessment |
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| Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Depressed mood | Psychiatric disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Genital discharge | Reproductive system and breast disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Ingrown hair | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Surgery | Surgical and medical procedures | MedDRA 12.0 | Non-systematic Assessment |
|
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