An open label clinical trial to evaluate the efficacy of Pachmeena Tonic in Ajeerna (Indigestion).
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Improvement in Fullness of Stomach
研究概览
简要总结
It is an open label single centric, prospective interventional clinical study to evaluate the efficacy of Pachmeena tonic on 50 patients suffering from Ajeerna (Indigestion). The study will be conducted in Department of Panchkarma, NIA, Jaipur, Rajasthan.
50 patients of Ajeerna (Indigestion) will be randomly selected from OPD, NIA. Pachmeena tonic will be administered to Patients in a dose of 10 ml orally thrice a day before meal with lukewarm water for duration of 15 days. Follow up will be done for 15 days.
The primary outcome measures will be to assess the efficacy of Pachmeena tonic in patients of Ajeerna (Indigestion) by assessing Improvement in Acid regurgitation on Day 0, Day 15th and after Follow up. The secondary outcome (other subjective parameters, as per validated symptom severity grading criteria for the patients with Ajeerna (Indigestion), developed by Hu WH, Wong YH et al. (J Gasteroenterol Hrpatol 2002; 17(5): 545-51.) will be assessed on Day 0, Day 15 and after Follow up (Day 30). A Performa shall be prepared incorporating the grading criteria for above mentioned parameters.
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects suffering from Ajeerna (Indigestion) and its related signs and symptoms such as fullness, bloating, nausea, gassy discomfort, loss of appetite, spasm and pain in the chest or abdomen for at least on two occasions in the preceding week and having normal hepatic and renal functions (LFT & RFT).
排除标准
- •Subjects with persistent dyspepsia, vomiting, severe epigastric pain unintentional weight loss, iron deficiency anemia, gastro-intestinal bleeding, dysphasia, odynophagia, previous gastric surgery, epigastric mass, suspicious barium meal, peptic ulcer, and NSAID use.
- •Organic deformity or malignancy of the GI tract, significant systemic and psychological condition (s) which may hamper the study proceedings, conditions requiring immediate surgical intervention, Alcohol or drug abuse, pregnancy and lactating women.
结局指标
主要结局
Improvement in Fullness of Stomach
时间窗: 15 Days
次要结局
- Improvement in other subjective parameters(30 Days)