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| Name | Class |
|---|---|
| Fakultas Kedokteran Universitas Indonesia | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | 1 tablet of Reconyl, 3 times daily |
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| Control Group | Placebo Comparator | 1 tablet of placebo Reconyl, 3 times daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reconyl | Drug | 1 tablet of Reconyl, 3 times daily |
|
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dewi S Rosdiana, Dr,MD,MKes | Department Pharmacology & Therapeutics Faculty of Medicine Universitas Indonesia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imeri Fkui | Jakarta Pusat | DKI Jakarta | 10430 | Indonesia | ||
| Klinik Satelit Makara UI Depok |
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| ID | Term |
|---|---|
| D003371 | Cough |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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| Placebo tablet of Reconyl | Drug | 1 tablet of placebo Reconyl, 3 times daily |
|
| Depok |
| West Java |
| Indonesia |
| D013568 | Pathological Conditions, Signs and Symptoms |