NCT07420491

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2025

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 26, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 3, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 3, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 12, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 19, 2026

Completed
Last Updated

February 19, 2026

Status Verified

February 1, 2026

Enrollment Period

3 months

First QC Date

February 12, 2026

Last Update Submit

February 12, 2026

Conditions

Cough

Outcome Measures

Primary Outcomes (1)

  • Changes of VAS Score on Cough

    Changes of VAS Score on Cough from Baseline to Day 7 of study treatment.

    7 days

Secondary Outcomes (4)

  • Changes of LCQ-acute score on Cough

    7 days

  • Renal function (Serum creatinine and eGFR)

    7 days

  • Liver function (ALT and AST)

    7 days

  • Adverse events

    7 days

Study Arms (2)

Reconyl

EXPERIMENTAL

1 tablet of Reconyl 225 mg three times daily

Drug: Reconyl

Placebo of Reconyl

PLACEBO COMPARATOR

1 tablet of Reconyl Placebo three times daily

Drug: Placebo of Reconyl

Interventions

ReconylDRUG

Reconyl will be given 1 tablet three times daily as the Investigational Product.

Also known as: Herbakof
Reconyl
Placebo of ReconylDRUG

Placebo of Reconyl will be given 1 tablet three times daily as the Placebo Comparator.

Placebo of Reconyl

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Velia Medika Primary Care Clinic

Jakarta, Jakarta Special Capital Region, 12430, Indonesia

Location

MeSH Terms

Conditions

Cough

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jusuf Kristianto, MD, PhD

    Velia Medika Primary Care Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2026

First Posted

February 19, 2026

Study Start

June 26, 2025

Primary Completion

October 3, 2025

Study Completion

October 3, 2025

Last Updated

February 19, 2026

Record last verified: 2026-02

Locations

ID(1)