To Evaluate Efficacy & safety of Dipya Acidity Relief Tablet in Management of chronic Gastritis.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1. Reduction in heartburn/epigastric discomfort
研究概览
简要总结
Chronic gastritis & Acid reflux, also known as gastroesophageal reflux disease (GERD), and heartburn are prevalent gastrointestinal disorders that result from damage to stomach lining & the backflow of stomach acid into the oesophagus. These conditions can lead to symptoms such as burning chest pain, regurgitation, and discomfort, Bloating significantly impacting daily activities and overall quality of life. While numerous over-the-counter (OTC) remedies, including antacids and proton pump inhibitors (PPIs), are available, many individuals still experience persistent symptoms, indicating a need for improved therapeutic options.
Recent research has highlighted the limitations of existing treatments, such as delayed onset of action, potential side effects, and inadequate symptom relief. As such, there is growing interest in developing a novel acidity relief tablet that combines effective active ingredients with a formulation aimed at rapid action and prolonged relief.
The Dipya Acidity Relief Tablet is 100 % ayurvedic formulation which acts through different pathways to treat Acidity /Chronic Gastritis .The purpose of this clinical trial is to rigorously evaluate the efficacy, safety, and tolerability of the Dipya Acidity Relief tablet. Participants will be monitored for symptom relief over a specified period, and data will be collected on primary & secondary outcomes, including the duration of relief and any adverse effects experienced. By assessing the efficacy & safety of this , the trial aims to provide evidence that supports its potential as a preferred option for patients seeking effective and long term ayurvedic solution from acid-related symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or Female Study Participants aged between 18 to 50 years, inclusive, at the time of signing the informed consent.
- •Completed the screening process within 3 days prior to randomization.
- •Study participant has understood and signed the informed consent form to participate in the study.
- •Study participant willing to be available for the entire study period and adhere to protocol requirements as evidenced by signing the informed consent document.
- •Study participants clinically diagnosed with chronic gastritis.
排除标准
- 未提供
结局指标
主要结局
1. Reduction in heartburn/epigastric discomfort
时间窗: Visit 0: Screening Day 0 (-3 days) | - Visit 1: Randomization in the study Day 1 | - Visit 2: Day 15 | - Visit 3: Day 30 | - Visit 4: Day 45 | - Visit 5: Day 60 (±3 days)
2. Reduction in acid reflux in
时间窗: Visit 0: Screening Day 0 (-3 days) | - Visit 1: Randomization in the study Day 1 | - Visit 2: Day 15 | - Visit 3: Day 30 | - Visit 4: Day 45 | - Visit 5: Day 60 (±3 days)
3.Relief from gas and bloating.
时间窗: Visit 0: Screening Day 0 (-3 days) | - Visit 1: Randomization in the study Day 1 | - Visit 2: Day 15 | - Visit 3: Day 30 | - Visit 4: Day 45 | - Visit 5: Day 60 (±3 days)
4. Relief from Nausea & vomiting
时间窗: Visit 0: Screening Day 0 (-3 days) | - Visit 1: Randomization in the study Day 1 | - Visit 2: Day 15 | - Visit 3: Day 30 | - Visit 4: Day 45 | - Visit 5: Day 60 (±3 days)
5. Improvement in appetite
时间窗: Visit 0: Screening Day 0 (-3 days) | - Visit 1: Randomization in the study Day 1 | - Visit 2: Day 15 | - Visit 3: Day 30 | - Visit 4: Day 45 | - Visit 5: Day 60 (±3 days)
次要结局
- 1. Changes in Laboratory Safety Parameters (CBC, LFT, KFT) from baseline to the end of the study.(2. Change in vital signs from baseline to the end of therapy.)
研究者
Dr.jai Kini
Maharastra University of Health sciences, Nashik