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

Study Overview
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Brief Summary
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The purpose of this study is to investigate the efficacy of Phytus in Acute Cough

Detailed Description
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Common colds are the most frequently encountered human diseases worldwide. Common cold is a conventional term used for mild upper respiratory illnesses, which comprises a heterogeneous group of self-limited diseases caused by numerous viruses. The frequency is age-specific with fewer episodes in adults than in younger children. Cough due to the common cold is probably the most common cause of acute cough. In a significant subset of patients with post infectious cough, the etiology is probably an inflammatory response triggered by a viral upper respiratory infection (ie, the common cold). The resultant sub-acute or chronic cough can be considered to be due to an upper airway cough syndrome, previously referred to as postnasal drip syndrome. Thyme leaf (Thymus vulgaris) expels phlegm and relieves congestion . It is antiseptic and an immune stimulant. The primary chemical constituents of Thyme include essential oil (borneol, carvacrol, cymol, linalool, thymol), bitter principle, tannin, flavonoids (apigenin, luteolin), saponins, and triterpenic acids. Thyme warms and stimulates the lungs, expels mucus, and relieves congestion. It also helps deter bacterial, fungal, and viral infections. The thymol content of thyme works as an expectorant and cough suppressant and is frequently used in cough syrups.

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

Conditions
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Cough, Common Cold

Intervention / Treatment
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* Drug: Phytus (Cisti, Thyme and Ivy Leaves)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cough attributed to URTI such as the common cold Moderate to severe day cough according to questionnaire (score at least 3 on all 3 questions relating to day cough) considering the day prior to enrollment. Moderate to severe night cough score according to questionnaire (score at least 3 of 2 of the three questions relating to the evaluation of nocturnal cough Exclusion Criteria: Diagnosis of chronic cardiac condition, or cystic fibrosis or any anatomical respiratory tract anomalies, Received antihistamines or any cough medicine the day prior to study entry,Known sensitivity to any component of Phytus

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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. | Drug: Phytus (Cisti, Thyme and Ivy Leaves)<br>* Phytus is a medicinal herb containing Ivy leaves, Cisti and Thyme.<br>* Other names: herbal medicine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in day cough score at end of study | 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) | 4 nights (onset of trial Night 1 to Night 4) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in night cough score at end of study | 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). | 4 nights (onset of trial Night 1 to Night 4) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cough, thyme, Cisti, Ivy Leaves