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.

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.

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)