A prospective, open label, single centre study for evaluation of efficacy and safety of Appelite Syrup in the management of Dyspepsia (Indigestion),Loss of Appetite And Acidity
试验速览
- 阶段
- Phase 3 4
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 550
- 试验地点
- 1
- 主要终点
- 1.Percentage of Participants with Overall Response.
研究概览
简要总结
The Study is a Prospective, open-label, and single-centre study for evaluation of safety and efficacy of Appelite syrup in the management of Dyspepsia (indigestion), loss of appetite, and acidity.
Eligible patients, both male and female above 18 years of age with symptomatic Dyspepsia (indigestion), loss of appetite, and acidity. The decision to prescribe Appelite Syrup will be made by the treating physician as per clinical judgement.
A detailed medical history will be obtained, and a physical examination will be conducted for each patient by the study investigators. The treatment duration is 04 weeks, and patients will be followed up till the end of the study (week 5).
At screening (Day -1 to Day 0), the potential patients will be identified by the site team, and written informed consent for patients aged 18 years and above will be procured before any study-related procedures are undertaken. The assessment, as per the schedule of assessments , would be performed at screening and enrolment to determine eligibility.
A total of 550 subjects will be enrolled in the study. The subject would be informed to visit the clinic in 01 weeks (Visit 2), 02 weeks (Visit 3), 04 weeks (Visit 4), and 05 weeks (visit 5). Safety assessment will be done throughout the duration of the study.
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
- 18.00 Year(s) 至 95.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients aged above 18 years of age.
- •2.Patient with a diagnosis of Dyspepsia (indigestion) or loss of appetite or acidity.
- •3.Patient or Parent or legal guardian willing to give a written informed consent or parental consent or assent form.
- •4.Able to or Willing to strictly adhere to the investigator’s prescription.
排除标准
- •1.Individuals were excluded if they had taken any medications that might interfere with the action of the study medications prior to the start of the study or during the study.
- •2.Patients with a medical history and diagnosis of Diabetes were excluded from the study.
- •3.Female subjects who are pregnant or lactating or planning to become pregnant during the study period.
- •Females who are not ready to use acceptable contraceptive methods during the course of study.
结局指标
主要结局
1.Percentage of Participants with Overall Response.
时间窗: Up to 5 Weeks
2.Evaluate the changes in Dyspepsia (indigestion), Loss of appetite, and RDQ Score.
时间窗: Up to 5 Weeks
次要结局
- 1.Number of Participants with Treatment-Related Treatment-Emergent Adverse Events (TEAEs).(2.Safety evaluation of Appelite syrup.)
研究者
Dr Ashwin Porwal
Healing Hands Clinic Pvt. Ltd.