The Efficacy and Safety of Reconyl in Acute Cough Treatment

February 12, 2026 updated by: Dexa Medica Group

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate The Efficacy and Safety of Reconyl in Acute Cough Treatment

This is a 2-arm, prospective, randomized, double-blind, parallel, controlled, non-inferiority study comparing Reconyl at a dose of 225 mg three times daily and Reconyl Placebo three times daily for a 7-day course of therapy.

Reconyl is a combination of four Indonesian herbals, Vitex trifolia folium, Zingiber officinale rhizome, Abrus precatorius folium, and Phaleria macrocarpa fructus, which have been traditionally used in treating cough and common cold. A combination of these herbals is expected to relieve cough and soothe throat, provide a promising cough treatment which has no side effects.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

There will be 2 groups of treatment; each group will consist of 72 subjects with the treatment regimens for 7 days:

Treatment I : 1 tablet of Reconyl 225 mg three times daily; Treatment II : 1 tablet of Reconyl Placebo three times daily.

Subjects will be asked to come to the clinic at Baseline and at Visit 1 (Day 7) for evaluation of treatment efficacy. During the 7-day study period, subjects should record product consumption, any adverse events, and their daily VAS score in the provided Patient's Diary.

The safety profile of study medication other than vital signs and adverse event will be measured at Baseline and End of Study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
144

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • Jakarta Special Capital Region
      • Jakarta, Jakarta Special Capital Region, Indonesia, 12430
        • Velia Medika Primary Care Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Signed informed consent from the subject or the subject's legally acceptable representatives (must obtained before any trial related activities)
  2. Male or female subjects, aged 18-50 years at screening
  3. Experience acute cough, defined as sudden onset dominant or main symptom of acute or worsened cough, with or without sputum, in the span of 72 hours, avoiding prescription and non-prescription cough-relieving medications (e.g. antitusives such as codeine-based cough supressants or dextromethorphan HBr, and mucolytics such as N-acetylsistein, Bromhexin and Ambroxol), within 24 hours before entering the study.
  4. The condition of the patient does not have any illness other than acute cough that could possibly interfere with the study evaluation, such as chronic obstructive pulmonary disease (COPD), suspect GERD, rhinitis, asthma, tuberculosis (TB), and pneumonia.
  5. Cooperative and able to fill out study material

Exclusion Criteria:

  1. Subject with febrile within 24 hours before screening, or has body temperature ≥ 38°C during screening visit
  2. Personal/family history of allergy or hypersensitivity or contradiction to any component of the drugs
  3. History or clinical evidence of immunosuppression according to investigator assessment, or currently under treatment with immunosuppressive agents
  4. Participation in any other trial less than 90 days before
  5. Pregnancy or lactation
  6. History of drug or alcohol abuse within 12 months prior to screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Reconyl
1 tablet of Reconyl 225 mg three times daily
Drug: Reconyl
Reconyl will be given 1 tablet three times daily as the Investigational Product.
Other Names:
  • Herbakof
Placebo Comparator: Placebo of Reconyl
1 tablet of Reconyl Placebo three times daily
Drug: Placebo of Reconyl
Placebo of Reconyl will be given 1 tablet three times daily as the Placebo Comparator.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes of VAS Score on Cough
Time Frame: 7 days
Changes of VAS Score on Cough from Baseline to Day 7 of study treatment.
7 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes of LCQ-acute score on Cough
Time Frame: 7 days
Changes of LCQ-acute score on Cough from Baseline to Day 7 of study treatment.
7 days
Renal function (Serum creatinine and eGFR)
Time Frame: 7 days
Concentration of serum creatinine and eGFR at Baseline and at the End of study
7 days
Liver function (ALT and AST)
Time Frame: 7 days
Concentration of aspartate transaminase (AST) to alanine transaminase (ALT) at Baseline and at the End of study
7 days
Adverse events
Time Frame: 7 days
Adverse event, will be observed throughout the study conduct
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dexa Medica Group

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
PT Equilab International

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jusuf Kristianto, MD, PhD, Velia Medika Primary Care Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 26, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 3, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 3, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 12, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 19, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 19, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR.101/EQL/2022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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