CTRI/2025/06/089312进行中（未招募）不适用
Evaluate the Clinical Effectiveness of the Ayurvedic Formulation Acidogrit in the Management of Functional Dyspepsia:Prospective,Open Label,Single Arm, Observational Study.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 63
- 试验地点
- 3
- 主要终点
- Change in Global Overall Symptom Scale
研究概览
简要总结
This open label, single arm, prospective observational study will assess the effectiveness of Acidogrit in Functional Dyspepsia patients. Patients will be screened on the basis of Inclusion/Exclusion criteria and enrolled after obtaining written Informed consent. The Patients will be followed-up for the next 30 days from the day of enrolment. Primary and secondary outcome will be evaluated by assessing Global Overall Symptom Scale and Short Form-Nepean Dyspepsia Index
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosis of functional dyspepsia/ Postprandial Distress Syndrome (PDS) and Epigastric Pain Syndrome by fulfilling Rome IV criteria Written informed consent signed by patient and willing to comply with the study procedure.
排除标准
- •Subjects having a history of structural disease of Oesophagus Stomach and duodenum.
- •Subjects having a history of previous abdominal surgery.
- •Subjects with any active GI Bleeding epigastric mass and peptic ulcer.
- •Chronic alcoholics and habitual tobacco chewers or any substance abuse.
- •Pregnant and lactating women.
- •Any condition the investigator identifies that can confound the participants ability to participate in the study properly.
结局指标
主要结局
Change in Global Overall Symptom Scale
时间窗: Baseline to Day 30.
次要结局
- Change in Short Form-Nepean Dyspepsia Index(Baseline to Day 30.)
研究者
Dr Preeti Rajpoot
Patanjali Wellness
研究点 (3)
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