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

NCT ID: NCT02981147

Last Updated: 2018-07-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-14
• Study Completion Date: 2018-03-30

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.

Conditions

Cough; Common Cold

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

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.

Group Type: EXPERIMENTAL

Phytus (Cisti, Thyme and Ivy Leaves)

Intervention Type: DRUG

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

Interventions

Phytus (Cisti, Thyme and Ivy Leaves)

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

Intervention Type: DRUG

Other Intervention Names

herbal medicine

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PharmEvo Pvt Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Masood Jawaid, MRCS,FCPS

Role: STUDY_DIRECTOR

PharmEvo Pvt Ltd

Locations

KCHS Medical Center 1st Floor, Tipu Sultan Road.

Karachi, Sindh, Pakistan

Countries

Pakistan

Other Identifiers

PE/PK/PYTUS/SP/2017-01

Identifier Type: -

Identifier Source: org_study_id