A Prospective open labelled, Non-randomized ,phase II,clinical trial of Saamuthara chooranam in the management of Eri Gunmam (peptic ulcer disease)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- b)heart burn
研究概览
简要总结
The study is a prospective open labelled non randomised phase II clinical trial to determine the efficacy and safety of Saamuthara Chooranam in patients with Erigunmam(Peptic Ulcer Disease).In this clinical trial to be held at GSMC,Palayamkottai 60 patients (30 in OPD + 30 in IPD) will be recruited and the trial drug will be administered at the dose of 180mg/kg/BW/Twice a day/ (orally) A/F along with ghee as adjuvant for a period of 45 days.All the study related data will be recorded and documented in a separate file for each patients.In case of any adverse event (AE) is noticed and it will be referred to pharmaco vigilence department of SCRI.Further management of patient will be given OPD,GSMC.During this trial all the efficacy and safety parameters will be recorded in the CRF.After completion of the trial all the study related data will be analysed statistically.
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
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients having symptoms of with a)epigastric pain b)heart burn c)nausea d)vomiting e)belching f)water brash g)lose of weight h)indigestion i)bloating of abdomen 2.Patients who are willing to take upper gastro-interstinal endoscopy 3.Patients who are willing to give blood specimen for laboratory investigation when required.
排除标准
- •1.Pregnancy 2.Lactating mother 3.Recent malignancy or radiation therapy 4.Gastro esophageal refulx disease 5.Pancreatitis 6.Inflammatory bowel disease 7.Acute hepatitis.
结局指标
主要结局
b)heart burn
时间窗: 45days
h)water brash
时间窗: 45days
The outcome is reduction in clinical symptoms of
时间窗: 45days
c)vomiting
时间窗: 45days
d)nausea
时间窗: 45days
e)belching
时间窗: 45days
f)indigestion
时间窗: 45days
a)epigastric pain
时间窗: 45days
g)bloating of abdomen
时间窗: 45days
次要结局
- 1.Evaluation of pharmacological activity of saamuthara chooranam(2.Evaluation of siddha parameters changes in Erikunmam during trial period)