CE 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. Duration: one night

The placebo intervention is a similar syrup of taste and colour, with general protective components and other necessary synthetic components which may have an influence on cough, without the specific natural protective components. Dosage form: syrup. Dosage: 5 ml. Duration: one night

Cough

Acute Upper Respiratory Tract Infection

The intervention product is a medical device in Europe due to its non-pharmacological mode of action, which makes the product compliant to the medical device definition. It is made of specific extracts of plants (plantago and thymus) which provide the product with protective characteristics of the oropharynx. These protective features enable the syrup to reduce the irritative cough promoting stimuli on the throat, which decrease urge to cough threshhold. In addition to these extract, honey completes the formula. The product does not contain any artificial component and no preservatives.

Cough Syrup for adults and children

The placebo intervention is a syrup of same taste and colour without the natural protective components but with the necessary synthetic preservatives and other co-sweeteners to guarantee quality and safety. The placebo has, in fact, all the features of a cough syrup since true placebo syrup is not possible in cough. The lack of specific natural protective components is weighed against the presence of other necessary substances which may still have an effect on cough, but this effect is not envisaged to be a specific protective effect.

Placebo

Pediatric Community Ambulatory Clinic - Petach-Tikva

Pediatric Community Ambulatory Clinic

Comparison of a Protective Cough Syrup Against Placebo on Night Cough in Children 1-5 Years Coughing Since 1- 2 Days Due to Common Cold

A Randomized, Double-blind Study to Evaluate the Efficacy and Tolerability of a Cough Syrup Containing Specific Plant Extracts (Poliflav M.A.) and Honey Versus Placebo in Cough Due to Upper Respiratory Tract Infection

Night cough frequency is the most invasive element of distress to the child and family. The questionnaire rating night cough is filled in the morning following enrollment, relating to the passed night. The basal night score is the score of the night before enrollment.

All these other elements constitute cough invasiveness into the quality of life of child and parents

Avner Herman Cohen

Prof. Herman Avner Cohen

Clalit Health Services

Aboca Spa Societa' Agricola

According to a predertermined list, the two products are provided in identical bottles and cartons appropriately labelled so as to ensure respect of the randomization list as well as blinding of all study participants.

Phytus (Cisti, thyme and Ivy leaves) given to patients on day 1 and day 4. On 4th day, night and day cough score along with adverse event will be assessed. Sponsor will bear the treatment cost during the study time period.

Common Cold

Phytus is a medicinal herb containing Ivy leaves, Cisti and Thyme.

Phytus (Cisti, Thyme and Ivy Leaves)

KCHS Medical Center 1st Floor, Tipu Sultan Road.

PEACe: Ivy, Thyme and Cisti Extract (Phytus) Efficacy in Acute Cough

A validated cough questionnaire measuring 3 aspects of daytime cough (frequency, severity, bothersomeness) on a 7 point Likert scale was used each evening to rate the passed day, as regards these aspects. The scale rates each parameter from 0 (not at all) to 6 (extremely)

A validated cough questionnaire measuring 5 aspects of night cough (frequency, severity, bothersomeness, child sleep and parents' sleep) on a 7 point Likert scale was used each morning to rate the past night. The scale rates each parameter from 0 (not at all) to 6 (extremely).

PharmEvo Pvt Ltd

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.

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.

Dosage is 5 ml three times a day for 4 nights, 3 days

Cough syrup for adults and children

Pediatric Ambulatory Clinic Bat-Yam

Pediatric Ambulatory Clinic Kfar-Saba

Pediatric Ambulatory Clinic Ramat Aviv Gimel

Efficacy & Tolerability of a Specific Plantain,Thyme and Honey Cough Syrup vs Placebo in Child Cough Due to Common Cold

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.

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.

common cold/čiobrelis

Comparison of a Protective Cough Syrup Against Placebo on Night Cough in Children 1-5 Years Coughing Since 1- 2 Days Due to Common Cold

PEACe: Ivy, Thyme and Cisti Extract (Phytus) Efficacy in Acute Cough

Efficacy & Tolerability of a Specific Plantain,Thyme and Honey Cough Syrup vs Placebo in Child Cough Due to Common Cold

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