CoughPhase 3NCT07420491
The Efficacy and Safety of Reconyl in Acute Cough Treatment
A Phase 3 study testing Reconyl in people with Cough, run by Dexa Medica Group at 1 site in Indonesia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Cough
- What is being tested?
- Reconyl
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 1 siteIndonesia
- Study dates
- 26 Jun 2025to 3 Oct 2025
- Phase
- Phase 3
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Signed informed consent from the subject or the subject's legally acceptable representatives (must obtained before any trial related activities)
- Male or female subjects, aged 18-50 years at screening
- 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.
- 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.
- Cooperative and able to fill out study material
Who cannot join
- Subject with febrile within 24 hours before screening, or has body temperature ≥ 38°C during screening visit
- Personal/family history of allergy or hypersensitivity or contradiction to any component of the drugs
- History or clinical evidence of immunosuppression according to investigator assessment, or currently under treatment with immunosuppressive agents
- Participation in any other trial less than 90 days before
- Pregnancy or lactation
- History of drug or alcohol abuse within 12 months prior to screening
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Velia Medika Primary Care Clinic
Jakarta, Jakarta Special Capital Region, 12430
About this study
Official title: 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.
Read the 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.
- Conditions
- Cough
- Being tested
- Reconyl, Placebo of Reconyl
- Medical subject headings
- Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReconylDrug
Also called Herbakof
Reconyl will be given 1 tablet three times daily as the Investigational Product.
Placebo of ReconylDrug
Placebo of Reconyl will be given 1 tablet three times daily as the Placebo Comparator.
| Study group | Role | What they receive |
|---|---|---|
| Reconyl | Experimental | 1 tablet of Reconyl 225 mg three times daily Receives: Drug: Reconyl |
| Placebo of Reconyl | Placebo comparator | 1 tablet of Reconyl Placebo three times daily Receives: Drug: Placebo of Reconyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of VAS Score on Cough
Changes of VAS Score on Cough from Baseline to Day 7 of study treatment.
Measured: 7 days
Secondary outcomes (4)
Changes of LCQ-acute score on Cough
Changes of LCQ-acute score on Cough from Baseline to Day 7 of study treatment.
Measured: 7 days
Renal function (Serum creatinine and eGFR)
Concentration of serum creatinine and eGFR at Baseline and at the End of study
Measured: 7 days
Liver function (ALT and AST)
Concentration of aspartate transaminase (AST) to alanine transaminase (ALT) at Baseline and at the End of study
Measured: 7 days
Adverse events
Adverse event, will be observed throughout the study conduct
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start26 Jun 2025
- Primary completion3 Oct 2025
- Study completion3 Oct 2025
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dexa Medica Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PT Equilab International
- Responsible party
- Sponsor
- Investigators
- Jusuf Kristianto, MD, PhD, Principal investigator, Velia Medika Primary Care Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07420491
- Sponsor's protocol ID
- CR.101/EQL/2022
- Status last verified
- Feb 2026
- First submitted
- 12 Feb 2026
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate The Efficacy and Safety of Reconyl in Acute Cough Treatment
- ClinicalTrials.gov ID
- NCT07420491
- Acronym / sponsor ID
- CR.101/EQL/2022
- Conditions
- Cough
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Dexa Medica GroupIndustry (pharma, biotech, devices)
- Collaborators
- PT Equilab International
- Study start
- 26 Jun 2025 (actual)
- Primary completion
- 3 Oct 2025 (actual)
- Study completion
- 3 Oct 2025 (actual)
- First posted
- 19 Feb 2026 (actual)
- 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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reconyl | Experimental | Drug: Reconyl1 tablet of Reconyl 225 mg three times daily |
| Placebo of Reconyl | Placebo comparator | Drug: Placebo of Reconyl1 tablet of Reconyl Placebo three times daily |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Signed informed consent from the subject or the subject's legally acceptable representatives (must obtained before any trial related activities)
- Male or female subjects, aged 18-50 years at screening
- 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.
- 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.
- Cooperative and able to fill out study material
Key exclusion criteria (6 listed)
- Subject with febrile within 24 hours before screening, or has body temperature ≥ 38°C during screening visit
- Personal/family history of allergy or hypersensitivity or contradiction to any component of the drugs
- History or clinical evidence of immunosuppression according to investigator assessment, or currently under treatment with immunosuppressive agents
- Participation in any other trial less than 90 days before
- Pregnancy or lactation
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 |
|---|---|---|
| ReconylAlso: HerbakofReconyl will be given 1 tablet three times daily as the Investigational Product. | Drug | Reconyl |
| Placebo of ReconylPlacebo of Reconyl will be given 1 tablet three times daily as the Placebo Comparator. | Drug | Placebo of Reconyl |
Primary outcome
Changes of VAS Score on Cough
Time frame: 7 days
Changes of VAS Score on Cough from Baseline to Day 7 of study treatment.
4 secondary outcomes
Changes of LCQ-acute score on Cough
Time frame: 7 days
Renal function (Serum creatinine and eGFR)
Time frame: 7 days
Liver function (ALT and AST)
Time frame: 7 days
Adverse events
Time frame: 7 days
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 19 Feb 2026.
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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.
Jusuf Kristianto, MD, PhD principal investigator
Velia Medika Primary Care Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Reconyl in people with Cough, run by Dexa Medica Group at 1 site in Indonesia.
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 5 inclusion and 6 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 19 Feb 2026. 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 Indonesia. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Changes of VAS Score on Cough (time frame: 7 days). 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 19 Feb 2026.