Safety and Efficacy Reconyl for Cough With/Without Sore Throat

Dexa Medica

Status and phase: Completed; Phase 2

Conditions: Cough

Treatments: Drug: Reconyl; Drug: Placebo tablet of Reconyl

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06510257

CRSU.P.Dexa/06/20/10.03A

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

60 participants in 2 patient groups, including a placebo group

Treatment Group

Experimental group

Description:

1 tablet of Reconyl, 3 times daily

Treatment:

Drug: Reconyl

Control Group

Placebo Comparator group

Description:

1 tablet of placebo Reconyl, 3 times daily

Treatment:

Drug: Placebo tablet of Reconyl