Safety and Efficacy Reconyl for Cough With/Without Sore Throat

NCT06510257 | Completed Phase 2

• 1 other identifier: CRSU.P.Dexa/06/20/10.03A
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Cough

Keywords

Cough with sore throat; Cough without sore throat; Reconyl

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

Treatment Group

EXPERIMENTAL

1 tablet of Reconyl, 3 times daily

Drug: Reconyl

Control Group

PLACEBO COMPARATOR

1 tablet of placebo Reconyl, 3 times daily

Drug: Placebo tablet of Reconyl

Interventions

Reconyl DRUG

1 tablet of Reconyl, 3 times daily

Also known as: HerbaKOF

Treatment Group

Placebo tablet of Reconyl DRUG

1 tablet of placebo Reconyl, 3 times daily

Control Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Dexa Medica Group: lead
• Fakultas Kedokteran Universitas Indonesia: collaborator

Study Sites (2)

Imeri Fkui

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

Klinik Satelit Makara UI Depok

Depok, West Java, Indonesia

Location

MeSH Terms

Conditions

Cough

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dewi S Rosdiana, Dr,MD,MKes

  Department Pharmacology & Therapeutics Faculty of Medicine Universitas Indonesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: July 15, 2024
• First Posted: July 19, 2024
• Study Start: July 23, 2024
• Primary Completion: September 30, 2024
• Study Completion: October 3, 2024
• Last Updated: February 7, 2025

Record last verified: 2025-02

Locations

ID (2)