Clinical trial NCT02981147: PEACe: Ivy, Thyme and Cisti Extract (Phytus) Efficacy in Acute Cough
Official title: PEACe: Ivy, Thyme and Cisti Extract (Phytus) Efficacy in Acute Cough
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cough
Common Cold
Keywords: cough
thyme
Cisti
Ivy Leaves
Lead sponsor: PharmEvo Pvt Ltd
Sponsor class: INDUSTRY
First posted: 2016-12-05
Enrollment: 210
Sex: ALL
Minimum age (years): 2
Maximum age (years): 79
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the efficacy of Phytus in Acute Cough

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in day cough score at end of study
timeFrame: 4 nights (onset of trial Night 1 to Night 4)
Secondary outcomes:
measure: Change in night cough score at end of study
timeFrame: 4 nights (onset of trial Night 1 to Night 4)
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: KCHS Medical Center 1st Floor, Tipu Sultan Road.
state: Sindh
Study officials:
affiliation: PharmEvo Pvt Ltd
name: Masood Jawaid, MRCS,FCPS
role: STUDY_DIRECTOR
References: