Safety and Efficacy Reconyl for Cough With/Without Sore Throat

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
      • Imeri Fkui
  • Jawa Barat
    • Depok, Jawa Barat, Indonesia
      • Klinik Satelit Makara UI Depok

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Healthy men or women aged 18 to 60 years with cough with/without sore throat with a maximum onset of 3 days.
2. Signing the informed consent.

Exclusion Criteria:

1. Body temperature of > 37.3˚C and/or refuse to follow health protocol for COVID-19
2. Known hypersensitivity to herbal drugs
3. Pregnant or lactating women
4. Have received any anti-inflammatory or cough-alleviating drugs within the past 24 hours
5. Presence of vomiting or diarrhea within the past 24 hours and still ongoing at the start of study
6. Severe illness, e.g. severe hypertension, any other chronic infections or diseases that may induce cough, such as: pulmonary tuberculosis, gastrointestinal reflux diseases (GERD)

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: Treatment Group; 1 tablet of Reconyl, 3 times daily	Drug: Reconyl; 1 tablet of Reconyl, 3 times daily; Other Names: HerbaKOF
Placebo Comparator: Control Group; 1 tablet of placebo Reconyl, 3 times daily	Drug: Placebo tablet of Reconyl; 1 tablet of placebo Reconyl, 3 times daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Day 0, Day 1, Day 2, Day 3

Collaborators and Investigators

• Sponsor: Dexa Medica Group
• Collaborators: Fakultas Kedokteran Universitas Indonesia
• Investigators: Principal Investigator: Dewi S Rosdiana, Dr,MD,MKes, Department Pharmacology & Therapeutics Faculty of Medicine Universitas Indonesia

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2024
• Primary Completion (Actual): September 30, 2024
• Study Completion (Actual): October 3, 2024

Study Registration Dates

• First Submitted: July 15, 2024
• First Submitted That Met QC Criteria: July 15, 2024
• First Posted (Actual): July 19, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 5, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Cough with sore throat; Cough without sore throat; Reconyl
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Respiration Disorders; Otorhinolaryngologic Diseases; Signs and Symptoms, Respiratory; Pharyngeal Diseases; Cough; Pharyngitis
• Other Study ID Numbers: CRSU.P.Dexa/06/20/10.03A

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No