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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02981147
Other study ID # PE/PK/PYTUS/SP/2017-01
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date March 14, 2017
Est. completion date March 30, 2018

Study information

Verified date March 2017
Source PharmEvo Pvt Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 210
Est. completion date March 30, 2018
Est. primary completion date December 30, 2017
Accepts healthy volunteers No
Gender All
Age group 2 Years to 79 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Phytus (Cisti, Thyme and Ivy Leaves)
Phytus is a medicinal herb containing Ivy leaves, Cisti and Thyme.

Locations

Country Name City State
Pakistan KCHS Medical Center 1st Floor, Tipu Sultan Road. Karachi Sindh

Sponsors (1)

Lead Sponsor Collaborator
PharmEvo Pvt Ltd

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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)
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