An open label, interventional, single center, prospective clinical study to evaluate efficacy and safety of ‘AHPL/AYTAB/1514’ in patients suffering from halitosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- To evaluate effect of AHPL/AYTAB/1514 tablet in halitosis using Bad breath analyzer and on organoleptic assessment scale
研究概览
简要总结
This study is an open label, interventional, single center, prospective clinical study to evaluate efficacy and safety of ‘AHPL/AYTAB/1514’ in patients suffering from halitosis. Patients will be recruited from M.A. Rangoonwala College of Dental Sciences & Research Centre, 2390-B, KB Hidayatullah Road, Azam Campus, Pune-1, India. subjects will be advised to take 2 tablets of ‘AHPL/AYTAB/1514’ four times a day (i.e. 2 tablets after breakfast, 2 tablets after lunch, 2 tablets after evening tea time/ snacks and 2 tablets after dinner) orally for 60 days. All study subjects will be advised to keep 2 tablets of ‘AHPL/AYTAB/1514’ beneath the tongue and allow them to dissolve. From day 60 onwards till day 75, all study subjects will be advised not to use the study drug and come to follow up on day 75 (last study visit) to observe any relapse/recurrence of halitosis. Primary outcome will be to evaluate effect of AHPL/AYTAB/1514 tablet in halitosis using Bad breath analyzer and on organoleptic assessment scale at screening visit, day o, day 15, day 30, day 45, day 60 and day 75.
Secondary outcomes would be assessment of Gingivitis on Loesan and Silness gingival index score, assessment of dental plaque on Turesky modification of Quigley Hein index score, assessment of intensity of Sore throat on a 4 points scale, assessment of intensity of Cough on a 4 points scale, assessment of acceptability of trial drug, assessment of incidence and severity of infections during study period, assessment of Quality of Life, assessment of overall treatment satisfaction by patient and physician on global assessment scale for overall improvement, assessment of drug compliance, assessment of adverse events/adverse drug reactions, assessment of drug tolerability and assessment of changes in laboratory parameters. The time points for secondary outcomes will be screening visit, day o, day 15, day 30, day 45, day 60 and day 75
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 54.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Healthy male and female subjects of age between 18-54 years 2.Subject willing to participate in clinical trial and who have read, understood and signed informed consent form 3.Subjects suffering from moderate to severe halitosis analyzed on Bad Breath Analyzer 4.Subjects not suffering from severe gingival diseases.
排除标准
- •1.Subjects who had destructive periodontal disease or who had undergone a periodontal surgery in the past three months will be excluded from the study 2.Subjects with Loe and Silness gingival index score 3 3.Subjects with Turesky modification of Quiely Hein index score of more than 4 4.Subject who used antibiotic, antimicrobial, analgesic medications, mouthwash, mouth fresheners or desensitizing toothpaste during the previous 1 month 5.Subject having any history of dentine hypersensitivity treatment 6.Subject having any removable device such as a removable partial denture or orthodontic retainer 7.Subject having presence of any ï¬xed appliance, large or defective restorations, cracked enamel 8.Subjects with any medically compromised conditions contraindicating the oral examination 9.Patients with preexisting systemic disease necessitating long-term medications, genetic and endocrinal disorders 10.Subjects with significant abnormal laboratory parameters 11.ECG demonstrating any signs of uncontrolled arrhythmia acute ischemia and X ray chest showing any active lesion of tuberculosis 12.Pregnant and lactating women.
结局指标
主要结局
To evaluate effect of AHPL/AYTAB/1514 tablet in halitosis using Bad breath analyzer and on organoleptic assessment scale
时间窗: Screening visit, Day o, Day 15, Day 30, Day 45, Day 60 and Day 75
次要结局
- 1.Assessment of Gingivitis(2.Assessment of dental plaque)