A PROSPECTIVE OPENLABELLED,NON-RANDOMIZED,PHASE II CLINICAL TRIAL OF VASAMBU 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
- 40
- 试验地点
- 1
- 主要终点
- 1.Epigastric pain
研究概览
简要总结
The study is a prospective open labelled phase ll Non randomised clinical study to evaluate the therapeutic efficacy of Vasambu Chooranam in the management of Erigunmam(Peptic Ulcer Disease).The trial drug will be administered at the dose of 0.5g -1g twice a day (orally) A/F 45 days along with Honey as adjuvant in 40 patients.The trial period of 12 months will be carried out in Government Siddha Medical College and Hospital Palayamkottai, Tirunelveli, Tamil Nadu.The secondary outcome will be the evaluation of siddha diagnostic parameters , assessment of safety profile of trial drug, assessment of pharmacological and biochemical parameters of trial drug.In case of any adverse events (AE) is noticed and it will be referred to Pharamacovigilance department of SCRI.Further management of Patients will be given in OPD facility
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 epigastric pain,heart burn,nausea,vomiting,loss of weight,water brash, indigestion and bloating of abdomen 2.Patients who are willing to take upper gastrointestinal endoscopy 3.Patients who are willing to give blood specimen and laboratory investigation when required.
排除标准
- •1.Pregnancy 2.lactating mother 3.Diabetes Mellitus 4.Recent malignancy or radiation therapy 5.Gastro esophageal reflux disease 6.Pancreatitis 7.Inflammatory Bowel Disease 8.Acute hepatitis.
结局指标
主要结局
1.Epigastric pain
时间窗: 45 days
2.heart burn
时间窗: 45 days
3.nausea
时间窗: 45 days
If during treatment or after treatment reduction of the following symptoms
时间窗: 45 days
7.indigestion
时间窗: 45 days
4.vomiting
时间窗: 45 days
5.water brash
时间窗: 45 days
6.loss of weight
时间窗: 45 days
8.bloating of abdomen
时间窗: 45 days
次要结局
- To evaluate the biochemical and physio-chemical and phytochemical analysis of clinical trial drug(To evaluate the antimicrobial activity of trial drug)