Evaluation of efficacy of violet oil preparation in nocturnal cough in children with upper respiratory tract infection

Evaluation of the efficacy of violet oil preparation on the frequency and severity of nocturnal cough in children aged 2 to 12 years with upper respiratory tract infection (common cold) compared to diphenhydramine: a randomized clinical trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20191127045522N1

Enrollment

Registered

2020-03-30

Start date

2020-04-08

Completion date

Unknown

Last updated

2020-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: Cough due to upper respiratory tract infection(common cold). Condition 2: cough. Acute nasopharyngitis [common cold] Cough

Interventions

Intervention 1: Intervention group: Product made from violet oil topically applied on chest 2 times. Duration of treatment is 2 days. Intervention 2: Control group: Diphenhydramine syrup is produced b

Eligibility

Sex/Gender

All

Age

2 Years to 12 Years

Inclusion criteria

Inclusion criteria: Cough due to upper respiratory tract infection (common cold) for less than 7 days Concomitant symptoms (mild fever: less than 39 ° C, sore throat, cramps, rhinorrhea, mild headache, feeling tired, sneezing Age 2 to 12 years Having the desire and consent for intervention

Exclusion criteria

Exclusion criteria: Frequent admission in hospital Children with signs and symptoms of asthma, pneumonia, allergic rhinitis, sinusitis, laryngo tracheobronchitis, congenital heart disease, chronic lung disease, diabetes, kidney disease Allergies before entering the study (presence of symptoms such as i itchy eye & nose, a history of prolonged cold periods,history of repeating similar symptoms, positive family history of allergy, history of drug and food allergy), The presence of sign and symptoms of a Reactive Airway Disease including: tachypnea and tachycardia, short breath, chest tightness ) Getting any anti cough drug before intervention

Design outcomes

Secondary

Measure	Time frame
Time to control symptoms. Timepoint: Any time during the study. Method of measurement: Report by the child's parents.	—

Primary

Measure	Time frame
Cough frequency. Timepoint: At the beginning of the study, the first and second day of intervention. Method of measurement: Likert scale Checklist.;Cough severity. Timepoint: At the beginning of the study, the first and second day of intervention. Method of measurement: Likert scale Checklist.;Nightly sleep quality of the child. Timepoint: At the beginning of the study, the first and second day of intervention. Method of measurement: Likert scale Checklist.;Nightly sleep quality of the parent. Timepoint: At the beginning of the study, the first and second day of intervention. Method of measurement: Likert scale Checklist.	—

Measure

Time frame

Cough frequency. Timepoint: At the beginning of the study, the first and second day of intervention. Method of measurement: Likert scale Checklist.;Cough severity. Timepoint: At the beginning of the study, the first and second day of intervention. Method of measurement: Likert scale Checklist.;Nightly sleep quality of the child. Timepoint: At the beginning of the study, the first and second day of intervention. Method of measurement: Likert scale Checklist.;Nightly sleep quality of the parent. Timepoint: At the beginning of the study, the first and second day of intervention. Method of measurement: Likert scale Checklist.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactAli Jabbari

Iran University of Medical Sciences

mralijabari1358@gmail.com+98 21 5558 0388

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026