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Completed

NCT Number: NCT06510257

Safety and Efficacy Reconyl for Cough With/Without Sore Throat

This study is a prospective, randomized, double-blind and placebo-controlled study to find out if reconyl may relieve the acute cough with/without sore throat.

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Key information

Conditions

Cough Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Imeri Fkui, Jakarta Pusat, DKI Jakarta, Indonesia

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About this study

Reconyl is a mixed extract from 4 Indonesian herbs, Vitex trifolia (Legundi), Zingiber officinale var. Amarum (Jahe Gajah), Abrus precatorius (Saga), and Phaleria macrocarpa (Mahkota Dewa), which have been known traditionally to relieve cough, respiratory congestion, and sore throat.

There will be two parallel groups of 30 subjects per group (a total of 60 subjects) planned to be enrolled in this study.

The investigational product: tablets @ 225 mg of Reconyl. Dose administration: One tablet of Reconyl or Placebo, given 3 times daily, for 3 days.

Eligible subjects will be instructed to perform a daily self-assessment on the cough symptoms over the 3 days of treatment, in the Subject Diary. Subject shall return to the study clinic 3 days ± 24 hours after the first dose, for completion of the subject's participation in the study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy men or women aged 18 to 60 years with cough with/without sore throat with a maximum onset of 3 days.
  • Signing the informed consent.

Exclusion criteria

  • Body temperature of > 37.3˚C and/or refuse to follow health protocol for COVID-19
  • Known hypersensitivity to herbal drugs
  • Pregnant or lactating women
  • Have received any anti-inflammatory or cough-alleviating drugs within the past 24 hours
  • Presence of vomiting or diarrhea within the past 24 hours and still ongoing at the start of study
  • Severe illness, e.g. severe hypertension, any other chronic infections or diseases that may induce cough, such as: pulmonary tuberculosis, gastrointestinal reflux diseases (GERD)

Treatment and study plan

Reconyl

Drug

1 tablet of Reconyl, 3 times daily

Other names: HerbaKOF

Placebo tablet of Reconyl

Drug

1 tablet of placebo Reconyl, 3 times daily

Primary outcomes

  1. Cough score

    Time frame: Day 0, Day 1, Day 2, Day 3

    Scoring will be performed and recorded daily in the Subject Diary at time 0, every night time and before the morning dose.

    At the End of Study (last visit) will be assessed by the subject and recorded by the Investigator.

    Cough score:

    • Day time: 0 = No cough; 1= Transient cough occasionally during the daytime; 2 = Frequent cough mildly affecting daily life; 3 = Frequent cough severely affecting daily life.
    • Night time: 0 = No cough; 1= Transient cough before sleep or occasional cough during the night; 2 = Cough mildly affecting night sleep; 3 = Cough severely affecting night sleep.

  2. Visual Analogue Scale (VAS)

    Time frame: Day 0, Day 1, Day 2, Day 3

    Visual Analogue Scale (VAS) for sore throat (0 - 100), with 0 indicates asymptomatic and 100 refers to the most serious or severe symptom.

    VAS will be assessed and recorded daily in Subject Diary at time 0, every night time and before the morning dose.

    At the End of Study (last visit) will be assessed by the subject and recorded by the Investigator.

  3. Adverse events

    Time frame: Day 0, Day 1, Day 2, Day 3

    Any adverse events (AE) and serious adverse events (SAE) will be observed throughout the study conduct.

Sponsors and collaborators

Lead sponsor

Dexa Medica Group

Industry

Collaborators

  • Fakultas Kedokteran Universitas Indonesia

Registry information

Official study title

Safety and Efficacy of Reconyl for Cough With/Without Sore Throat: A Preliminary Study

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 19, 2024
Registry last updated
Feb 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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