A randomized controlled open label clinical study to evaluate the safety and efficacy of Active Antacid Suspension (DRF/AY/5018) and Active Antacid Tablets(DRF/AY/4026) in comparison with standard modern treatment in management of hyperacidity and functional dyspepsia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 127
- 试验地点
- 1
- 主要终点
- 1. To evaluate the efficacy of Antacid Tablet (DRF/AY/4026 ) Antacid Suspension (DRF/AY/5018) in the Management of the Hyperacidity & Functional Dyspepsia in comparison to a marketed comparator.
研究概览
简要总结
This study was a randomized open clinical study to evaluate the safety and efficacy of two Ayurvedic formulations - Active Antacid Tablets and Active Antacid Suspension in the management of the hyperacidity & functional dyspepsia in comparison to treatment with marketed antacid tablets and suspension. The study was conducted after obtaining prior IEC approvals from the IEC and written informed consent from all subjects before recruitment.
A total of 127 male and female subjects aged between 20-50 years with functional dyspepsia and hyperacidity were recruited in the study as per the inclusion and exclusion criteria from Kayachikitsa OPD , Dhanwantary Ayurvedic College, Chandigarh and randomized as below:
Group A (31 subjects) : Active Antacid Suspension : 15 ml TDS and SOS
Group B (37) : Active Antacid Tablets : 2 Tablets TDS after meals and SOS
Group C (26) : Active Antacid Suspension: 15 ml TDS and SOS
Group D (33): Active Antacid Tablets: 2 Tablets TDS after meals and SOS
The study period was of 6 weeks including 4 weeks of therapy and two follow-ups at weekly intervals after stoppage of treatment. Subjects were followed up at days 7,14,21,28 during the treatment period for the assessment of dyspepsia using The Hong Kong Index of Dyspepsia and at days 35 and 42 afterwithdrawal of study medication in order to study the lasting effect of treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 20.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or Female subjects in the age group of 20 years to 50 years.
- •Subjects with greater than or equal to 24% of dyspepsia as per the Hong Kong Index of Dyspepsia
- •Subjects with absence of any clinical or ultrasonographic evidence of organic disease that was accounted for the symptoms
- •Subjects who were willing to sign informed consent and to come for regular followup examinations as & when required.
- •In the event of subject undergoing treatment for dyspepsia, washout period of 2 days was given prior to inclusion.
排除标准
- •1.Subjects with presence of or history of peptic and duodenal ulcers disease or gastric malignancy any gastrointestinal surgery, reflux oesophagitis, any upper or lower G.l. bleeding, with clinical evidence of irritable bowel syndrome or any psychiatric disease.
- •Subjects with clinically diagnosed serious medical or surgical illness (like: Diabetes, CAD, HT, SLE, Rheumatoid Arthritis, Psoriatic Arthritis) where compliance was difficult.
- •Subjects not willing to follow up for the study visits.
- •Subjects with age range below 20 years and above 50 years
- •Uncooperative Subjects or subjects not willing to sign Informed Consent or giving consent for study required procedure like endoscopy.
结局指标
主要结局
1. To evaluate the efficacy of Antacid Tablet (DRF/AY/4026 ) Antacid Suspension (DRF/AY/5018) in the Management of the Hyperacidity & Functional Dyspepsia in comparison to a marketed comparator.
时间窗: day 7,14,21,28,35,42
次要结局
- To evaluate overall subject safety(day 7,14,21,28,35,42)