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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02981147
Recruitment Status : Completed
First Posted : December 5, 2016
Last Update Posted : July 9, 2018
Sponsor:
Information provided by (Responsible Party):
PharmEvo Pvt Ltd

Study Description
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Brief Summary:
The purpose of this study is to investigate the efficacy of Phytus in Acute Cough

Condition or disease Intervention/treatment Phase
Cough Common Cold Drug: Phytus (Cisti, Thyme and Ivy Leaves) Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 210 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PEACe: Ivy, Thyme and Cisti Extract (Phytus) Efficacy in Acute Cough
Actual Study Start Date : March 14, 2017
Actual Primary Completion Date : December 30, 2017
Actual Study Completion Date : March 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough

Arms and Interventions
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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 Name: herbal medicine


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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).


Eligibility Criteria
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Ages Eligible for Study:   2 Years to 79 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02981147


Locations
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Pakistan
KCHS Medical Center 1st Floor, Tipu Sultan Road.
Karachi, Sindh, Pakistan
Sponsors and Collaborators
PharmEvo Pvt Ltd
Investigators
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Study Director: Masood Jawaid, MRCS,FCPS PharmEvo Pvt Ltd
More Information
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Responsible Party: PharmEvo Pvt Ltd
ClinicalTrials.gov Identifier: NCT02981147    
Other Study ID Numbers: PE/PK/PYTUS/SP/2017-01
First Posted: December 5, 2016    Key Record Dates
Last Update Posted: July 9, 2018
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by PharmEvo Pvt Ltd:
cough
thyme
Cisti
Ivy Leaves
Additional relevant MeSH terms:
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Common Cold
Cough
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
 Respiratory Tract Infections
Infections
Picornaviridae Infections
RNA Virus Infections
Virus Diseases