CoughNCT02486835
Efficacy & Tolerability of a Specific Plantain,Thyme and Honey Cough Syrup vs Placebo in Child Cough Due to Common Cold
A study testing Cough syrup for adults and children in people with Cough, run by Clalit Health Services at 4 sites in Israel.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 1 year to 5 years
- Conditions the study is for
- Cough
- What is being tested?
- Cough syrup for adults and children
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 4 sitesIsrael
- Study dates
- 23 Dec 2015to 6 Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- cough attributed to infection of the upper respiratory tract since less or equal than 7 days,
- children aged 1 to 5 years
- score of three or more of al least two of the following three questions relating to night cough, frequency of nocturnal cough, impact on sleep of child and impact on sleep of parent,
- score of at least three of all questions assessing daytime cough considering the day prior to study entry
- written consent by a parent.
Who cannot join
- Children with a diagnosis of acute laryngotracheal bronchitis, pneumonia, asthma, sinusitis, allergic rhinitis, as well as chronic cardiac condition, or cystic fibrosis or any anatomical respiratory tract anomalies,
- Children who received antihistamines or any cough medicine the day prior to study entry,
- The administration of any steroid preparation by oral administration or inhalation on the day prior to study entry,
- Known sensitivity to any component of placebo or to Plantago lanceolata or Thymus vulgaris, honey or any other component of the cough syrup.
Trial locations and contacts
4 sites in 1 country.
Israel4 sites
Pediatric Ambulatory Clinic Bat-Yam
Bat Yam
Pediatric Ambulatory Clinic Kfar-Saba
Kfar Saba
Pediatric Community Ambulatory Clinic - Petach-Tikva
Petah Tikva
Pediatric Ambulatory Clinic Ramat Aviv Gimel
Tel Aviv
About this study
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.
Read the detailed description
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.
- Conditions
- Cough
- Being tested
- Cough syrup for adults and children, Placebo
- Medical subject headings
- Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cough syrup for adults and childrenDevice
Also called Poliflav M.A.-honey cough syrup
Dosage is 5 ml three times a day for 4 nights, 3 days
PlaceboDevice
Dosage is 5 ml three times a day for 4 nights, 3 days
| Study group | Role | What they receive |
|---|---|---|
| "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. Receives: Device: Cough syrup for adults and children |
| 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. Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline up to night 1
Secondary outcomes (14)
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
Measured: baseline up to night 1
Change in night cough frequency score in the female population coughing since 1-2 days
All these other elements constitute cough invasiveness into the quality of life of child and parents
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: baseline up to day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2015 (estimated)
- Study start23 Dec 2015
- Primary completion3 Apr 2016
- Study completion6 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for CoughStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clalit Health Services
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Avner Herman Cohen, Clalit Health Services
- Investigators
- Herman A Cohen, Prof., Principal investigator, Clalit HS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02486835
- Sponsor's protocol ID
- ABO-cough-2015
- Status last verified
- Jan 2018
- First submitted
- 17 May 2015
- Last updated
- 29 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Middleton KR, Hing E. National Hospital Ambulatory Medical Care Survey: 2004 outpatient department summary. Adv Data. 2006 Jun 23;(373):1-27.
PubMed 16841784Paul 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.
PubMed 15231978Paul 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.
PubMed 18056558Wegener 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.
PubMed 10483683Canciani 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.
PubMed 24917119Rimsza 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.
PubMed 18676517Schramm 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.
PubMed 12617614Bogdanov 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.
PubMed 19155427Cohen 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.
PubMed 22869830
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy & Tolerability of a Specific Plantain,Thyme and Honey Cough Syrup vs Placebo in Child Cough Due to Common Cold
- ClinicalTrials.gov ID
- NCT02486835
- Acronym / sponsor ID
- ABO-cough-2015
- Conditions
- Cough
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Clalit Health ServicesUniversity, hospital or other
- Study start
- 23 Dec 2015 (actual)
- Primary completion
- 3 Apr 2016 (actual)
- Study completion
- 6 Apr 2016 (actual)
- First posted
- 1 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "Cough Syrup for adults and children" | Experimental | Device: Cough syrup for adults and childrenMarked (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 | Device: PlaceboThe 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. |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- cough attributed to infection of the upper respiratory tract since less or equal than 7 days,
- children aged 1 to 5 years
- score of three or more of al least two of the following three questions relating to night cough, frequency of nocturnal cough, impact on sleep of child and impact on sleep of parent,
- score of at least three of all questions assessing daytime cough considering the day prior to study entry
- written consent by a parent.
Key exclusion criteria (4 listed)
- Children with a diagnosis of acute laryngotracheal bronchitis, pneumonia, asthma, sinusitis, allergic rhinitis, as well as chronic cardiac condition, or cystic fibrosis or any anatomical respiratory tract anomalies,
- Children who received antihistamines or any cough medicine the day prior to study entry,
- The administration of any steroid preparation by oral administration or inhalation on the day prior to study entry,
- Known sensitivity to any component of placebo or to Plantago lanceolata or Thymus vulgaris, honey or any other component of the cough syrup.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cough syrup for adults and childrenAlso: Poliflav M.A.-honey cough syrupDosage is 5 ml three times a day for 4 nights, 3 days | Device | "Cough Syrup for adults and children" |
| PlaceboDosage is 5 ml three times a day for 4 nights, 3 days | Device | Placebo |
Primary outcome
Change in night cough frequency score in the general population
Time frame: baseline up to night 1
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.
14 secondary outcomes
Change in night cough frequency score in the population coughing since 1-2 days
Time frame: baseline up to night 1
Change in night cough frequency score in the female population coughing since 1-2 days
Time frame: baseline up to night 1
Change in night cough frequency score in the male population coughing since 1-2 days
Time frame: baseline up to night 1
Change in night cough severity score in the general population
Time frame: baseline up to night 1
Change in night cough severity score in the population coughing since 1-2 days
Time frame: baseline up to night 1
Change in night cough bothersomeness score in the general population
Time frame: baseline up to night 1
Change in night cough bothersomeness score in the population coughing since 1-2 days
Time frame: baseline up to night 1
Change in night cough influence on sleep of child score in the general population
Time frame: baseline up to night 1
Change in night cough influence on sleep of child score in the population coughing since 1-2 days
Time frame: baseline up to night 1
Change in night cough influence on sleep of parent score in the general population
Time frame: baseline up to night 1
Change in night cough influence on sleep of parent score in the population coughing since 1-2 days
Time frame: baseline up to night 1
Change in night cough combined score in the general population
Time frame: baseline up to night 1
Change in night cough combined score in the population coughing since 1-2 days
Time frame: baseline up to night 1
Change in day cough frequency score in the general population
Time frame: baseline up to day 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2018.
- Background: PubMed 16841784Middleton KR, Hing E. National Hospital Ambulatory Medical Care Survey: 2004 outpatient department summary. Adv Data. 2006 Jun 23;(373):1-27.
- Background: PubMed 15231978Paul 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.
- Background: PubMed 18056558Paul 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.
- Background: PubMed 10483683Wegener 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.
- Background: PubMed 24917119Canciani 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.
- Background: PubMed 18676517Rimsza 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.
- Background: PubMed 12617614Schramm 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.
- Background: PubMed 19155427Bogdanov 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.
- Background: PubMed 22869830Cohen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Herman A Cohen, Prof. principal investigator
Clalit HS
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cough syrup for adults and children in people with Cough, run by Clalit Health Services at 4 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in night cough frequency score in the general population (time frame: baseline up to night 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02486835, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2018.