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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
Sponsor:
Information provided by (Responsible Party):

Study Description
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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
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
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough
U.S. FDA Resources

Arms and Interventions

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 79 Years   (Child, Adult, Senior)
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

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


Contacts
Contact: Anum Siddiqui, PharmD 9221-34315195 anum.siddiqui@pharmevo.biz
Contact: Masood Jawaid, MRCS,FCPS 9221-34315195 masood.jawaid@pharmevo.biz

Locations
Pakistan
KCHS Medical Center 1st Floor, Tipu Sultan Road. Recruiting
Karachi, Sindh, Pakistan
Contact: Sohail Akhter, MBBS    0321-2396753    drsa99@yahoo.com   
Sponsors and Collaborators
PharmEvo Pvt Ltd
Investigators
Study Director: Masood Jawaid, MRCS,FCPS PharmEvo Pvt Ltd
More Information

Responsible Party: PharmEvo Pvt Ltd
ClinicalTrials.gov Identifier: NCT02981147     History of Changes
Other Study ID Numbers: PE/PK/PYTUS/SP/2017-01
First Posted: December 5, 2016    Key Record Dates
Last Update Posted: November 13, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
Cough
Common Cold
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections