The Efficacy and Safety of Reconyl in Acute Cough Treatment

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: Completed
• Conditions: Cough
• Intervention / Treatment: Drug: Reconyl; Drug: Placebo of Reconyl

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: Interventional
• Enrollment (Actual): 144
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Changes of VAS Score on Cough	Changes of VAS Score on Cough from Baseline to Day 7 of study treatment.	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of LCQ-acute score on Cough	Changes of LCQ-acute score on Cough from Baseline to Day 7 of study treatment.	7 days
Renal function (Serum creatinine and eGFR)	Concentration of serum creatinine and eGFR at Baseline and at the End of study	7 days
Liver function (ALT and AST)	Concentration of aspartate transaminase (AST) to alanine transaminase (ALT) at Baseline and at the End of study	7 days
Adverse events	Adverse event, will be observed throughout the study conduct	7 days

Collaborators and Investigators

• Sponsor: Dexa Medica Group
• Collaborators: PT Equilab International
• Investigators: Principal Investigator: Jusuf Kristianto, MD, PhD, Velia Medika Primary Care Clinic

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2025
• Primary Completion (Actual): October 3, 2025
• Study Completion (Actual): October 3, 2025

Study Registration Dates

• First Submitted: February 12, 2026
• First Submitted That Met QC Criteria: February 12, 2026
• First Posted (Actual): February 19, 2026

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: February 12, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Cough
• Other Study ID 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