Ignite Creation Date:
2025-12-18 @ 9:28 AM
Ignite Modification Date:
2025-12-23 @ 6:50 PM
Study NCT ID:
NCT00747747
Status:
None
Last Update Posted:
2012-03-14 00:00:00
First Post:
2008-09-04 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sinuclean's Treatment Of Sinusitis' Symptoms
Sponsor:
None
Organization:
Study Overview
Official Title:
Safety and Efficacy (for Symptoms Remission) of the Treatment of the Acute Episode of Sinusitis With Ecballium Elaterium (SINUclean DM® Nasal Spray) as Co-adjuvant of the Antibiotic Therapy: Comparative, Prospective, Randomized, Open Study.
Status:
None
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SToSS
Brief Summary:
The randomized subject with diagnosis of acute episode of sinusitis with symptoms and mucus in the paranasal sinuses, will treat his/her condition with background amoxicillin/clavulanate and with inhalation of Sinuclean or Saline, while the control group will not use any spray for symptom relief. Anti-histaminic, steroidal anti-inflammatory drugs are forbidden. The patient is requested to evaluate his state of symptoms by recording in a diary
* the pain or feeling of facial oppression;
* nasal dripping anterior or posterior;
* nasal congestion. SCALE 0 = no symptom
1. = mild symptom: clearly perceptible, but easily tolerated
2. = moderate symptom: clear awareness of the symptom, that is annoying but tolerable
3. = severe: symptom very annoying, difficult to tolerate, interfering with the ordinary life Four measures per day (2 for administration of the therapy - before/after) of which the median will be used; plus an evening measure "retrospective" of the past 12 hours.
If possible it will be assessed the status of paranasal sinuses before and after the treatment with a CT scan.
The treatment intervals is the week. After baseline and start of treatment, are planned two control visit. The subject will complete the study at the first control visit without symptoms. After the second visit, if the symptoms are still present, the subject will complete as a "treatment-failure".
* the pain or feeling of facial oppression;
* nasal dripping anterior or posterior;
* nasal congestion. SCALE 0 = no symptom
1. = mild symptom: clearly perceptible, but easily tolerated
2. = moderate symptom: clear awareness of the symptom, that is annoying but tolerable
3. = severe: symptom very annoying, difficult to tolerate, interfering with the ordinary life Four measures per day (2 for administration of the therapy - before/after) of which the median will be used; plus an evening measure "retrospective" of the past 12 hours.
If possible it will be assessed the status of paranasal sinuses before and after the treatment with a CT scan.
The treatment intervals is the week. After baseline and start of treatment, are planned two control visit. The subject will complete the study at the first control visit without symptoms. After the second visit, if the symptoms are still present, the subject will complete as a "treatment-failure".
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: