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| Name | Class |
|---|---|
| Farmaline Co.,Ltd., Thailand | UNKNOWN |
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The investigators proposed that the Cleanoze® is superior to the traditional nasal saline irrigation in term of the ease of use which will resulting in a better quality of life of the participants. This study will compared the efficacy, adverse reactions, complications and ease of use of Cleanoze® comparing with normal saline solution
Cleanoze® consists of a powder made up of Sodium chloride and Sodium Bicarbonate. This powder when dissolved in 250 ml of water is closely resembles the content of a body fluid which normally baths the outside of the cells of the body. This fluid is isotonic solution.
The nasal saline irrigation is the common procedure for upper respiratory tract infection patients including chronic rhinitis. The physician usually order the normal saline with appropriate medication e.g. anti-histamines, nasal steroids and anti-biotics to treat this condition.
The investigators proposed that the Cleanoze® is superior to the traditional nasal saline irrigation in term of the ease of use which will resulting in a better quality of life of the participants. This study will compared the efficacy, adverse reactions, complications and ease of use of Cleanoze® comparing with normal saline solution.
Study Population: Any patients with chronic rhinitis (e.g. allergic rhinitis, vasomotor rhinitis) will be randomized to receive the study or control medication. The investigators will include the children 5 years and above which able to doing the lavage under the parents assistant or by them self.
Study Design: Phase III randomized controlled trial
Sample Size: Estimate from pilot study, the 71 patients per arm was estimated (142 participants totally).
Study Duration:
Primary Objective: To compare the satisfaction of the patients using Cleanoze® versus conventional device
Secondary Objective(s):
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cleanoze® | Experimental | Cleanoze® consists of a powder made up of Sodium chloride and Sodium Bicarbonate. This powder when dissolved in 250 ml of water is closely resembles the content of a body fluid which normally baths the outside of the cells of the body. This fluid is isotonic solution. The patient will be instructed to use this isotonic solution for nasal irrigation daily. |
|
| Syringe irrigation | Active Comparator | Nasal irrigation using sterile 0.9% NaCl 250 ml by 20 ml syringe The patient will be instructed to use this isotonic solution for nasal irrigation daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cleanoze® | Drug | Cleanoze® consists of a powder made up of Sodium chloride and Sodium Bicarbonate. This powder when dissolved in 250 ml of water is closely resembles the content of a body fluid which normally baths the outside of the cells of the body. This fluid is isotonic solution. |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction score | This score will be evaluated at the end of 1 month using using the satisfaction questionaire | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| The adherence to Cleanoze® devic | The adherence will be evaluated by the diary that the investigator given to the participants | 1 month |
| The durability of the Cleanoze® device | The durability will be evaluated by inspecting the device at the end of 1 month period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patorn Piromchai, MD, MSc | Khon Kaen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Otolaryngology, Khonkaen University | Muang | Khonkaen | 40002 | Thailand |
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| ID | Term |
|---|---|
| D012220 | Rhinitis |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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|
| Saline (Syringe irrigation) | Drug | Nasal irrigation using 250 ml normal saline pushing into the nostril by 20 ml syringe |
|
| 1 month |
| The symptoms score of the patients | The symptoms score will be evaluated using the one-question VAS scale | 1 month |
| The Sino-Nasal Outcome Test-22 Questionnaire (SNOT-22) score | The SNOT-22 score will be evaluated by using SNOT-22 questionnaire | 1 month |
| Adverse events | The adverse events will be recorded in the case record form at follow-up time | 1 month |
| D010038 |
| Otorhinolaryngologic Diseases |
| D017670 |
| Sodium Compounds |