NCT07420491

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 144 (actual)
• Sponsor: Dexa Medica Group · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DRUG	Reconyl	Reconyl will be given 1 tablet three times daily as the Investigational Product.
DRUG	Placebo of Reconyl	Placebo of Reconyl will be given 1 tablet three times daily as the Placebo Comparator.

Timeline

• Start date: 2025-06-26
• Primary completion: 2025-10-03
• Completion: 2025-10-03
• First posted: 2026-02-19
• Last updated: 2026-02-19

Locations

1 site across 1 country: Indonesia