PEACe: Ivy, Thyme and Cisti Extract (Phytus) Efficacy in Acute Cough (PEACe)
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|ClinicalTrials.gov Identifier: NCT02981147|
Recruitment Status : Recruiting
First Posted : December 5, 2016
Last Update Posted : November 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cough Common Cold||Drug: Phytus (Cisti, Thyme and Ivy Leaves)||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1000 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||PEACe: Ivy, Thyme and Cisti Extract (Phytus) Efficacy in Acute Cough|
|Actual Study Start Date :||March 14, 2017|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2017|
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)
Phytus is a medicinal herb containing Ivy leaves, Cisti and Thyme.
Other Name: herbal medicine
- 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)
- 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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02981147
|Contact: Anum Siddiqui, PharmDfirstname.lastname@example.org|
|Contact: Masood Jawaid, MRCS,FCPSemail@example.com|
|KCHS Medical Center 1st Floor, Tipu Sultan Road.||Recruiting|
|Karachi, Sindh, Pakistan|
|Contact: Sohail Akhter, MBBS 0321-2396753 firstname.lastname@example.org|
|Study Director:||Masood Jawaid, MRCS,FCPS||PharmEvo Pvt Ltd|