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

NCT02981147 | Completed Phase 4 DMC

• 1 other identifier: PE/PK/PYTUS/SP/2017-01
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cough; Common Cold

Keywords

cough; thyme; Cisti; Ivy Leaves

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in night cough score at end of study

  4 nights (onset of trial Night 1 to Night 4)

Study Arms (1)

Intervention

EXPERIMENTAL

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)

Interventions

Phytus (Cisti, Thyme and Ivy Leaves) DRUG

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

Also known as: herbal medicine

Intervention

Eligibility Criteria

• Age: 2 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• PharmEvo Pvt Ltd: lead

Study Sites (1)

KCHS Medical Center 1st Floor, Tipu Sultan Road.

Karachi, Sindh, Pakistan

Location

MeSH Terms

Conditions

Cough; Common Cold

Interventions

Phytotherapy

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Masood Jawaid, MRCS,FCPS

  PharmEvo Pvt Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2016
• First Posted: December 5, 2016
• Study Start: March 14, 2017
• Primary Completion: December 30, 2017
• Study Completion: March 30, 2018
• Last Updated: July 9, 2018

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)