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Completed

NCT Number: NCT02981147

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

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

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Key information

Age range

2 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

KCHS Medical Center 1st Floor, Tipu Sultan Road.

Karachi, Sindh, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Phytus (Cisti, Thyme and Ivy Leaves)

Drug

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

Other names: herbal medicine

Primary outcomes

  1. Change in day cough score at end of study

    Time frame: 4 nights (onset of trial Night 1 to Night 4)

    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)

Secondary outcomes

  1. Change in night cough score at end of study

    Time frame: 4 nights (onset of trial Night 1 to Night 4)

    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).

Sponsors and collaborators

Lead sponsor

PharmEvo Pvt Ltd

Industry

Registry information

Acronym: PEACe

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Dec 5, 2016
Registry last updated
Jul 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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