Cough
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGReconyl
Reconyl will be given 1 tablet three times daily as the Investigational Product.
DRUGPlacebo of Reconyl
Placebo of Reconyl will be given 1 tablet three times daily as the Placebo Comparator.
Sponsors
Dexa Medica Group
PT Equilab International
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
1. Signed informed consent from the subject or the subject's legally acceptable representatives (must obtained before any trial related activities) 2. Male or female subjects, aged 18-50 years at screening 3. Experience acute cough, defined as sudden onset dominant or main symptom of acute or worsened cough, with or without sputum, in the span of 72 hours, avoiding prescription and non-prescription cough-relieving medications (e.g. antitusives such as codeine-based cough supressants or dextromethorphan HBr, and mucolytics such as N-acetylsistein, Bromhexin and Ambroxol), within 24 hours before entering the study. 4. The condition of the patient does not have any illness other than acute cough that could possibly interfere with the study evaluation, such as chronic obstructive pulmonary disease (COPD), suspect GERD, rhinitis, asthma, tuberculosis (TB), and pneumonia. 5. Cooperative and able to fill out study material
Exclusion criteria
1. Subject with febrile within 24 hours before screening, or has body temperature ≥ 38°C during screening visit 2. Personal/family history of allergy or hypersensitivity or contradiction to any component of the drugs 3. History or clinical evidence of immunosuppression according to investigator assessment, or currently under treatment with immunosuppressive agents 4. Participation in any other trial less than 90 days before 5. Pregnancy or lactation 6. History of drug or alcohol abuse within 12 months prior to screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes of VAS Score on Cough | 7 days | Changes of VAS Score on Cough from Baseline to Day 7 of study treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes of LCQ-acute score on Cough | 7 days | Changes of LCQ-acute score on Cough from Baseline to Day 7 of study treatment. |
| Renal function (Serum creatinine and eGFR) | 7 days | Concentration of serum creatinine and eGFR at Baseline and at the End of study |
| Liver function (ALT and AST) | 7 days | Concentration of aspartate transaminase (AST) to alanine transaminase (ALT) at Baseline and at the End of study |
| Adverse events | 7 days | Adverse event, will be observed throughout the study conduct |
Countries
Indonesia
Contacts
PRINCIPAL_INVESTIGATORJusuf Kristianto, MD, PhD
Velia Medika Primary Care Clinic
Outcome results
None listed