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Cough is a life saving reflex, therefore it is important, especially in pediatrics, to calm cough spells without sedating the reflex. The intent of this study is to use a protective syrup with does not act as a sedative or as a potent mucolytic and measure its efficacy and safety versus placebo in children with moderate to severe night and daily cough. Cough is assessed with a validated parent questionnaire. The degree of disturbance of cough is followed immediately after one night administration of the study products and daily for 4 nights, 3 days.
Cough is a life saving reflex, therefore it is important, especially in pediatrics, to calm cough spells without sedating the reflex. Looking into mechanisms for cough management different from mucolytics, or sedatives, such as protection of irritated pharynx mucosa from post nasal drip or other irritating substances is theoretically sound and shows practical interesting results.
A parallel comparison of efficacy and tolerability between such protective mechanism (acting through a barrier and radical scavenging action) due to natural substances (honey, plantago lanceolata and thymus vulgaris) and placebo has not been done so far, in very young children, especially in a time frame of 4 days. The intent of this study is to use the protective syrup versus placebo in children with moderate to severe night and daily cough, measured with a validated parent questionnaire. The degree of disturbance of cough is followed immediately after one night administration of the study products and daily for 4 nights, 3 days.
Assessment of effectiveness of the protective cough syrup as compared to placebo is considered very interesting due to the mechanism of the remedy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| "Cough Syrup for adults and children" | Experimental | Marked (authorized) medical device acting by protecting the oropharynx, in a non pharmacological way, to reduce cough. It contains honey, plantago lanceolata, thymus vulgaris.Dosage form: syrup Dosage: 5 ml three times a day. Frequency: the duration of the study for each patient is 4 nights, 3 days. |
|
| Placebo | Placebo Comparator | The placebo intervention is a syrup of same taste and colour without the protective components. Dosage form: syrup. Dosage: 5 ml three times a day Frequency: the duration of the study for each patient is 4 nights, 3 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cough syrup for adults and children | Device | Dosage is 5 ml three times a day for 4 nights, 3 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in night cough frequency score in the general population | Night cough frequency is the most invasive element of distress to the child and family. The questionnaire rating night cough is filled in each morning relating to the passed night for four nights. The basal night score is the score of the night before enrollment. | baseline up to night 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in night cough frequency score in the population coughing since 1-2 days | All these other elements constitute cough invasiveness into the quality of life of child and parents | baseline up to night 1 |
| Change in night cough frequency score in the female population coughing since 1-2 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Herman A Cohen, Prof. | Clalit HS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pediatric Ambulatory Clinic Bat-Yam | Bat Yam | Israel | ||||
| Pediatric Ambulatory Clinic Kfar-Saba |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16841784 | Background | Middleton KR, Hing E. National Hospital Ambulatory Medical Care Survey: 2004 outpatient department summary. Adv Data. 2006 Jun 23;(373):1-27. | |
| 15231978 | Background | Paul IM, Yoder KE, Crowell KR, Shaffer ML, McMillan HS, Carlson LC, Dilworth DA, Berlin CM Jr. Effect of dextromethorphan, diphenhydramine, and placebo on nocturnal cough and sleep quality for coughing children and their parents. Pediatrics. 2004 Jul;114(1):e85-90. doi: 10.1542/peds.114.1.e85. |
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| ID | Term |
|---|---|
| D003371 | Cough |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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| Placebo | Device | Dosage is 5 ml three times a day for 4 nights, 3 days |
|
All these other elements constitute cough invasiveness into the quality of life of child and parents |
| baseline up to night 1 |
| Change in night cough frequency score in the male population coughing since 1-2 days | All these other elements constitute cough invasiveness into the quality of life of child and parents | baseline up to night 1 |
| Change in night cough severity score in the general population | All these other elements constitute cough invasiveness into the quality of life of child and parents | baseline up to night 1 |
| Change in night cough severity score in the population coughing since 1-2 days | All these other elements constitute cough invasiveness into the quality of life of child and parents | baseline up to night 1 |
| Change in night cough bothersomeness score in the general population | All these other elements constitute cough invasiveness into the quality of life of child and parents | baseline up to night 1 |
| Change in night cough bothersomeness score in the population coughing since 1-2 days | All these other elements constitute cough invasiveness into the quality of life of child and parents | baseline up to night 1 |
| Change in night cough influence on sleep of child score in the general population | All these other elements constitute cough invasiveness into the quality of life of child and parents | baseline up to night 1 |
| Change in night cough influence on sleep of child score in the population coughing since 1-2 days | All these other elements constitute cough invasiveness into the quality of life of child and parents | baseline up to night 1 |
| Change in night cough influence on sleep of parent score in the general population | All these other elements constitute cough invasiveness into the quality of life of child and parents | baseline up to night 1 |
| Change in night cough influence on sleep of parent score in the population coughing since 1-2 days | All these other elements constitute cough invasiveness into the quality of life of child and parents | baseline up to night 1 |
| Change in night cough combined score in the general population | All these other elements constitute cough invasiveness into the quality of life of child and parents | baseline up to night 1 |
| Change in night cough combined score in the population coughing since 1-2 days | All these other elements constitute cough invasiveness into the quality of life of child and parents | baseline up to night 1 |
| Change in day cough frequency score in the general population | The questionnaire rating day cough is filled in each evening relating to the passed day for three days. The basal day score is the score of the day before enrollment. | baseline up to day 2 |
| Kfar Saba |
| Israel |
| Pediatric Community Ambulatory Clinic - Petach-Tikva | Petah Tikva | Israel |
| Pediatric Ambulatory Clinic Ramat Aviv Gimel | Tel Aviv | Israel |
| 18056558 | Background | Paul IM, Beiler J, McMonagle A, Shaffer ML, Duda L, Berlin CM Jr. Effect of honey, dextromethorphan, and no treatment on nocturnal cough and sleep quality for coughing children and their parents. Arch Pediatr Adolesc Med. 2007 Dec;161(12):1140-6. doi: 10.1001/archpedi.161.12.1140. |
| 10483683 | Background | Wegener T, Kraft K. [Plantain (Plantago lanceolata L.): anti-inflammatory action in upper respiratory tract infections]. Wien Med Wochenschr. 1999;149(8-10):211-6. German. |
| 24917119 | Background | Canciani M, Murgia V, Caimmi D, Anapurapu S, Licari A, Marseglia GL. Efficacy of Grintuss(R) pediatric syrup in treating cough in children: a randomized, multicenter, double blind, placebo-controlled clinical trial. Ital J Pediatr. 2014 Jun 10;40:56. doi: 10.1186/1824-7288-40-56. |
| 18676517 | Background | Rimsza ME, Newberry S. Unexpected infant deaths associated with use of cough and cold medications. Pediatrics. 2008 Aug;122(2):e318-22. doi: 10.1542/peds.2007-3813. |
| 12617614 | Background | Schramm DD, Karim M, Schrader HR, Holt RR, Cardetti M, Keen CL. Honey with high levels of antioxidants can provide protection to healthy human subjects. J Agric Food Chem. 2003 Mar 12;51(6):1732-5. doi: 10.1021/jf025928k. |
| 19155427 | Background | Bogdanov S, Jurendic T, Sieber R, Gallmann P. Honey for nutrition and health: a review. J Am Coll Nutr. 2008 Dec;27(6):677-89. doi: 10.1080/07315724.2008.10719745. |
| 22869830 | Background | Cohen HA, Rozen J, Kristal H, Laks Y, Berkovitch M, Uziel Y, Kozer E, Pomeranz A, Efrat H. Effect of honey on nocturnal cough and sleep quality: a double-blind, randomized, placebo-controlled study. Pediatrics. 2012 Sep;130(3):465-71. doi: 10.1542/peds.2011-3075. Epub 2012 Aug 6. |
| D013568 | Pathological Conditions, Signs and Symptoms |