An open-label, single-arm clinical study to assess the efficacy and safety of a Mouth-Dissolving Ayurvedic Tablet (MDAT) for symptomatic relief of acute cough, sore throat, hoarseness of voice and bad breath.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 66
- 试验地点
- 1
研究概览
简要总结
This Phase 3, open-label, single-arm interventional clinical study is designed to evaluate the efficacy, safety, and tolerability of a Mouth-Dissolving Ayurvedic Tablet (MDAT) in participants with acute or subacute cough (less than or equal 14 days duration) associated with sore throat, hoarseness of voice, and/or bad breath.
A total of 66 evaluable male and female participants aged 12–65 years with baseline cough Visual Analogue Scale (VAS) greater then or equal 3 will be enrolled. Participants will receive one MDAT tablet every 2 hours, up to a maximum of 6 tablets per day, for 7 consecutive days. The total duration of participation will be 14 days, including a 7-day treatment period and follow-up until Day 14.
The primary endpoint is the mean change in cough severity (VAS) from baseline to Day 7 (with interim assessment at Day 3). Secondary endpoints include mean change in sore throat VAS, Voice Handicap Index-10 (VHI-10), organoleptic score and Halimeter assessment for halitosis, time to meaningful cough relief, and proportion of participants achieving greater then or equal 50% reduction in cough VAS by Day 3 and Day 7. Safety will be assessed through monitoring of adverse events and laboratory parameters (CBC, RFT, LFT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 12.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and Female age between 12 and 65 years.
- •Acute or subacute cough with sore throat or hoarseness or bad breath of less than or equal to 14 days duration (onset less than or equal to 14 days).
- •Baseline cough VAS greater than or equal to 3 out of
- •Able and willing to comply with study procedures and give written informed consent.
- •Women of childbearing potential using reliable contraception, during the study period.
排除标准
- •Known allergy to any ingredient in the tablet.
- •Severe upper (pharyngitis) or lower respiratory infection (e.g., pneumonia), clinically suspected bacterial throat infection requiring antibiotics, or any condition requiring immediate hospitalization.
- •Chronic severe respiratory disease (e.g., COPD GOLD stage II–IV, uncontrolled asthma).
- •Use of oral or inhaled antibiotics or systemic corticosteroids in past 7 days.
- •Use of other cough or antitussive or antiseptic throat lozenges within 12 hours before baseline (short washout may be requested).
- •Pregnant or breastfeeding women.
- •Significant hepatic, renal, cardiac disease or immunosuppression.
- •Current smoker of grater then 20 cigarettes per day (optional exclusion), or any other condition in investigator’s opinion that precludes participation.
研究者
Dr R M Muthiah MBBS MD
Oxymed Hospital Medical & Healthcare Center,