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| Name | Class |
|---|---|
| PT Equilab International | INDUSTRY |
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This is a 2-arm, prospective, randomized, double-blind, parallel, controlled, non-inferiority study comparing Reconyl at a dose of 225 mg three times daily and Reconyl Placebo three times daily for a 7-day course of therapy.
Reconyl is a combination of four Indonesian herbals, Vitex trifolia folium, Zingiber officinale rhizome, Abrus precatorius folium, and Phaleria macrocarpa fructus, which have been traditionally used in treating cough and common cold. A combination of these herbals is expected to relieve cough and soothe throat, provide a promising cough treatment which has no side effects.
There will be 2 groups of treatment; each group will consist of 72 subjects with the treatment regimens for 7 days:
Treatment I : 1 tablet of Reconyl 225 mg three times daily; Treatment II : 1 tablet of Reconyl Placebo three times daily.
Subjects will be asked to come to the clinic at Baseline and at Visit 1 (Day 7) for evaluation of treatment efficacy. During the 7-day study period, subjects should record product consumption, any adverse events, and their daily VAS score in the provided Patient's Diary.
The safety profile of study medication other than vital signs and adverse event will be measured at Baseline and End of Study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reconyl | Experimental | 1 tablet of Reconyl 225 mg three times daily |
|
| Placebo of Reconyl | Placebo Comparator | 1 tablet of Reconyl Placebo three times daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reconyl | Drug | Reconyl will be given 1 tablet three times daily as the Investigational Product. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes of VAS Score on Cough | Changes of VAS Score on Cough from Baseline to Day 7 of study treatment. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of LCQ-acute score on Cough | Changes of LCQ-acute score on Cough from Baseline to Day 7 of study treatment. | 7 days |
| Renal function (Serum creatinine and eGFR) | Concentration of serum creatinine and eGFR at Baseline and at the End of study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jusuf Kristianto, MD, PhD | Velia Medika Primary Care Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Velia Medika Primary Care Clinic | Jakarta | Jakarta Special Capital Region | 12430 | Indonesia |
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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 of Reconyl | Drug | Placebo of Reconyl will be given 1 tablet three times daily as the Placebo Comparator. |
|
| 7 days |
| Liver function (ALT and AST) | Concentration of aspartate transaminase (AST) to alanine transaminase (ALT) at Baseline and at the End of study | 7 days |
| Adverse events | Adverse event, will be observed throughout the study conduct | 7 days |
| D013568 | Pathological Conditions, Signs and Symptoms |