CoughPhase 2NCT06510257
Safety and Efficacy Reconyl for Cough With/Without Sore Throat
A Phase 2 study testing Reconyl in people with Cough, run by Dexa Medica Group at 2 sites in Indonesia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 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
- 60 participants
- Where
- 2 sitesIndonesia
- Study dates
- 23 Jul 2024to 3 Oct 2024
- Phase
- Phase 2
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
Indonesia2 sites
Klinik Satelit Makara UI Depok
Depok, West Java
Imeri Fkui
Jakarta Pusat, DKI Jakarta, 10430
About this study
Official title: Safety and Efficacy of Reconyl for Cough With/Without Sore Throat: A Preliminary Study
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.
Read the detailed description
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.
- Conditions
- Cough
- Being tested
- Reconyl, Placebo tablet of Reconyl
- Keywords
- Cough with sore throat, Cough without sore throat, 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
1 tablet of Reconyl, 3 times daily
Placebo tablet of ReconylDrug
1 tablet of placebo Reconyl, 3 times daily
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | 1 tablet of Reconyl, 3 times daily Receives: Drug: Reconyl |
| Control Group | Placebo comparator | 1 tablet of placebo Reconyl, 3 times daily Receives: Drug: Placebo tablet of Reconyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cough score
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.
Measured: Day 0, Day 1, Day 2, Day 3
Visual Analogue Scale (VAS)
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.
Measured: Day 0, Day 1, Day 2, Day 3
Adverse events
Any adverse events (AE) and serious adverse events (SAE) will be observed throughout the study conduct.
Measured: Day 0, Day 1, Day 2, Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start23 Jul 2024
- Primary completion30 Sep 2024
- Study completion3 Oct 2024
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dexa Medica Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fakultas Kedokteran Universitas Indonesia
- Responsible party
- Sponsor
- Investigators
- Dewi S Rosdiana, Dr,MD,MKes, Principal investigator, Department Pharmacology & Therapeutics Faculty of Medicine Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06510257
- Sponsor's protocol ID
- CRSU.P.Dexa/06/20/10.03A
- Status last verified
- Feb 2025
- First submitted
- 15 Jul 2024
- Last updated
- 7 Feb 2025
- 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 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Reconyl for Cough With/Without Sore Throat: A Preliminary Study
- ClinicalTrials.gov ID
- NCT06510257
- Acronym / sponsor ID
- CRSU.P.Dexa/06/20/10.03A
- Conditions
- Cough
- Keywords
- Cough with sore throat, Cough without sore throat, Reconyl
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Dexa Medica GroupIndustry (pharma, biotech, devices)
- Collaborators
- Fakultas Kedokteran Universitas Indonesia
- Study start
- 23 Jul 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 3 Oct 2024 (actual)
- First posted
- 19 Jul 2024 (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 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.
Detailed description
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.
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 |
|---|---|---|
| Treatment Group | Experimental | Drug: Reconyl1 tablet of Reconyl, 3 times daily |
| Control Group | Placebo comparator | Drug: Placebo tablet of Reconyl1 tablet of placebo Reconyl, 3 times daily |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
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: HerbaKOF1 tablet of Reconyl, 3 times daily | Drug | Treatment Group |
| Placebo tablet of Reconyl1 tablet of placebo Reconyl, 3 times daily | Drug | Control Group |
Primary outcome
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.
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.
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.
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 7 Feb 2025.
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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.
Dewi S Rosdiana, Dr,MD,MKes principal investigator
Department Pharmacology & Therapeutics Faculty of Medicine Universitas Indonesia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Reconyl in people with Cough, run by Dexa Medica Group at 2 sites 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 2 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 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Cough score (time frame: Day 0, Day 1, Day 2, Day 3). The study lists 3 primary outcomes in all. 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 7 Feb 2025.