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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

Tracking Information
First Submitted Date  ICMJE November 22, 2016
First Posted Date  ICMJE December 5, 2016
Last Update Posted Date July 9, 2018
Actual Study Start Date  ICMJE March 14, 2017
Actual Primary Completion Date December 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 27, 2017)
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)
Original Primary Outcome Measures  ICMJE
 (submitted: November 30, 2016)
Change in day cough score at end of study [ Time Frame: 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)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 27, 2017)
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).
Original Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2016)
Change in night cough score at end of study [ Time Frame: 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).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PEACe: Ivy, Thyme and Cisti Extract (Phytus) Efficacy in Acute Cough
Official Title  ICMJE PEACe: Ivy, Thyme and Cisti Extract (Phytus) Efficacy in Acute Cough
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cough
  • Common Cold
Intervention  ICMJE Drug: Phytus (Cisti, Thyme and Ivy Leaves)
Phytus is a medicinal herb containing Ivy leaves, Cisti and Thyme.
Other Name: herbal medicine
Study Arms  ICMJE 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.
Intervention: Drug: Phytus (Cisti, Thyme and Ivy Leaves)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 6, 2018)
210
Original Estimated Enrollment  ICMJE
 (submitted: November 30, 2016)
1000
Actual Study Completion Date  ICMJE March 30, 2018
Actual Primary Completion Date December 30, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 79 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Pakistan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02981147
Other Study ID Numbers  ICMJE PE/PK/PYTUS/SP/2017-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party PharmEvo Pvt Ltd
Study Sponsor  ICMJE PharmEvo Pvt Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Masood Jawaid, MRCS,FCPS PharmEvo Pvt Ltd
PRS Account PharmEvo Pvt Ltd
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP