CoughPhase 4PEACeNCT02981147
PEACe: Ivy, Thyme and Cisti Extract (Phytus) Efficacy in Acute Cough
A Phase 4 study testing Phytus (Cisti, Thyme and Ivy Leaves) in people with Cough and Common Cold, run by PharmEvo Pvt Ltd at 1 site in Pakistan.
Trial summary
The purpose of this study is to investigate the efficacy of Phytus in Acute Cough Read more about this study
- Who is it for?
- Ages 2 to 79 years
- Conditions the study is for
- Cough, Common Cold
- What is being tested?
- Phytus (Cisti, Thyme and Ivy Leaves)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 sitePakistan
- Study dates
- 14 Mar 2017to 30 Mar 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 79 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
KCHS Medical Center 1st Floor, Tipu Sultan Road.
Karachi, Sindh
About this study
The purpose of this study is to investigate the efficacy of Phytus in Acute Cough
Read the 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.
- Conditions
- Cough, Common Cold
- Being tested
- Phytus (Cisti, Thyme and Ivy Leaves)
- Keywords
- cough, thyme, Cisti, Ivy Leaves
- Medical subject headings
- Cough, Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phytus (Cisti, Thyme and Ivy Leaves)Drug
Also called herbal medicine
Phytus is a medicinal herb containing Ivy leaves, Cisti and Thyme.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Phytus (Cisti, Thyme and Ivy Leaves) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 4 nights (onset of trial Night 1 to Night 4)
Secondary outcomes (1)
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).
Measured: 4 nights (onset of trial Night 1 to Night 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2016 (estimated)
- Study start14 Mar 2017
- Primary completion30 Dec 2017
- Study completion30 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoughStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- PharmEvo Pvt Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Masood Jawaid, MRCS,FCPS, Study director, PharmEvo Pvt Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02981147
- Sponsor's protocol ID
- PE/PK/PYTUS/SP/2017-01
- Acronym
- PEACe
- Status last verified
- Mar 2017
- First submitted
- 22 Nov 2016
- Last updated
- 9 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PEACe: Ivy, Thyme and Cisti Extract (Phytus) Efficacy in Acute Cough
- ClinicalTrials.gov ID
- NCT02981147
- Acronym / sponsor ID
- PEACe / PE/PK/PYTUS/SP/2017-01
- Conditions
- Cough, Common Cold
- Keywords
- cough, thyme, Cisti, Ivy Leaves
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- PharmEvo Pvt LtdIndustry (pharma, biotech, devices)
- Study start
- 14 Mar 2017 (actual)
- Primary completion
- 30 Dec 2017 (actual)
- Study completion
- 30 Mar 2018 (actual)
- First posted
- 5 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: Phytus (Cisti, Thyme and Ivy Leaves)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. |
Who may qualify
- Ages
- 2 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phytus (Cisti, Thyme and Ivy Leaves)Also: herbal medicinePhytus is a medicinal herb containing Ivy leaves, Cisti and Thyme. | Drug | Intervention |
Primary outcome
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)
1 secondary outcome
Change in night cough score at end of study
Time frame: 4 nights (onset of trial Night 1 to Night 4)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Masood Jawaid, MRCS,FCPS study director
PharmEvo Pvt Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Phytus (Cisti, Thyme and Ivy Leaves) in people with Cough and Common Cold, run by PharmEvo Pvt Ltd at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in day cough score at end of study (time frame: 4 nights (onset of trial Night 1 to Night 4)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2018.