Velia Medika Primary Care Clinic
Jakarta, Jakarta Special Capital Region, 12430, Indonesia
NCT Number: NCT07420491
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.
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Notify Me18 year–50 year
All sexes
Interventional
Phase 3
Jakarta, Jakarta Special Capital Region, 12430, Indonesia
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Reconyl will be given 1 tablet three times daily as the Investigational Product.
Other names: Herbakof
Placebo of Reconyl will be given 1 tablet three times daily as the Placebo Comparator.
Time frame: 7 days
Changes of VAS Score on Cough from Baseline to Day 7 of study treatment.
Time frame: 7 days
Changes of LCQ-acute score on Cough from Baseline to Day 7 of study treatment.
Time frame: 7 days
Concentration of serum creatinine and eGFR at Baseline and at the End of study
Time frame: 7 days
Concentration of aspartate transaminase (AST) to alanine transaminase (ALT) at Baseline and at the End of study
Time frame: 7 days
Adverse event, will be observed throughout the study conduct
Dexa Medica Group
Industry
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate The Efficacy and Safety of Reconyl in Acute Cough Treatment
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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