NCT06510257

Safety and Efficacy Reconyl for Cough With/Without Sore Throat

Safety and Efficacy of Reconyl for Cough With/Without Sore Throat: A Preliminary Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Dexa Medica Group · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DRUG	Reconyl	1 tablet of Reconyl, 3 times daily
DRUG	Placebo tablet of Reconyl	1 tablet of placebo Reconyl, 3 times daily

Timeline

• Start date: 2024-07-23
• Primary completion: 2024-09-30
• Completion: 2024-10-03
• First posted: 2024-07-19
• Last updated: 2025-02-07

Locations

2 sites across 1 country: Indonesia