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

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

Study Overview

• Status: Completed
• Conditions: Cough; Common Cold
• Intervention / Treatment: Drug: Phytus (Cisti, Thyme and Ivy Leaves)

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.

• Study Type: Interventional
• Enrollment (Actual): 210
• Phase: Phase 4

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan
      • KCHS Medical Center 1st Floor, Tipu Sultan Road.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 months to 77 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Phytus (Cisti, Thyme and Ivy Leaves); Phytus is a medicinal herb containing Ivy leaves, Cisti and Thyme.; Other Names: herbal medicine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: PharmEvo Pvt Ltd
• Investigators: Study Director: Masood Jawaid, MRCS,FCPS, PharmEvo Pvt Ltd

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2017
• Primary Completion (Actual): December 30, 2017
• Study Completion (Actual): March 30, 2018

Study Registration Dates

• First Submitted: November 22, 2016
• First Submitted That Met QC Criteria: November 30, 2016
• First Posted (Estimate): December 5, 2016

Study Record Updates

• Last Update Posted (Actual): July 9, 2018
• Last Update Submitted That Met QC Criteria: July 6, 2018
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: cough; thyme; Cisti; Ivy Leaves
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Picornaviridae Infections; Signs and Symptoms, Respiratory; Cough; Common Cold
• Other Study ID Numbers: PE/PK/PYTUS/SP/2017-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No