A PROSPECTIVE OPEN LABELLED, SINGLE ARM, NON-RANDOMISED,SINGLE CENTRIC PHASE II CLINICAL EVALUATION OF SIVATHAI CHOORANAM IN THE MANAGEMENT OF VATHA 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
- The outcome is the reduction in clinical symptoms of abdominal pain, fatigue and weakness, body pain,headache,dizziness ,polydipsia,xerostomia, constipation, vomiting and indigestion
研究概览
简要总结
This study is a prospective open labelled phase II Non randomized clinical study to evaluate the therapeutic efficacy of Sivathai Chooranam in the management of Vatha gunmam (Peptic ulce disease).The trial drug will be administered at the dose of 500 mg to 1 gram/ twice a day (orally with hot water) 45 days in 40 patients.The trial period of 12 months will be carried out in Government Siddha Medical College And Hospital Palayamkottai Tirunelveli Tamilnadu.The primary outcome will be the evaluation of therapeutic efficacy of the trial drug SIVATHAI CHOORANAM.The secondary outcome will be the evaluation of siddha diagnostic parameters, assessment of safety profile of trial drug, assesment of pharmacological and biochemical parameters of the trial drug.In case of any adverse events (AE) is noticed and it will be referred to pharmacovigilance department of SCRI.Further management of patients of will be given in OPD facilities.
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 with abdominal pain,fatigue and weakness,bodypain,headache,dizziness,polydipsia,xerostomia,constipation,vomiting and indigestion.
- •2.Patients who are willing to take upper gastrointestinal endoscopy
- •Patients who are willing to give blood specimen for lab investigation when required.
- •4.Patient willing to sign the informed consent indicating that they understand the purpose and procedures required for the study and are willing to participating the study.
排除标准
- •1.Pregnancy 2.Lactating mother
- •Recent malignancy or radiation therapy 4.Gastro esophageal reflux disease 5.Pancreatitis 6.Inflammotary Bowel Disease 7.Acute hepatitis 8.Patients considered unreliable by the investigator (e.g: drug addiction, Alcohol abuse).
结局指标
主要结局
The outcome is the reduction in clinical symptoms of abdominal pain, fatigue and weakness, body pain,headache,dizziness ,polydipsia,xerostomia, constipation, vomiting and indigestion
时间窗: 45 days
次要结局
- The secondary outcome will be the evaluation of siddha diagnostic parameters assessment of safety profile of trial drug assesment of pharmacological and biochemical parameters of the trial drug(45 days)