CTRI/2023/01/049226已完成4 期
A Single Centre, Randomized, Double Blind, Prospective, Comparative, Phase IV Clinical Study to evaluate Efficacy, Safety, and Tolerability of Gastroplex® Syrup by Powell Laboratories (P) Limited in Indian Patients with acute and Chronic gastritis.
Powell Laboratories (P) Limited0 个研究点目标入组 60 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Willing and able to provide written informed consent prior to any study specific procedures being performed.
- •2. Males and non-pregnant, non-lactating females between 18-70 years of age; inclusive based on the date of the Screening visit.
- •3. Subjects with symptoms of pain in abdomen, epigastric burning, Nausea and vomiting, and early satiety, Suggestive of acute or chronic gastritis.
- •4. Subject must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments.
排除标准
- •1) Pregnant and Lactating Female
- •2) Body mass index >35 kg/m2
- •3) Reports a history of allergic response(s) to the active ingredient or to any of the excipients of
- •the Investigational Medicinal product.
- •4) Reports history of Gastric Ulcer, Duodenal Ulcer.
- •5) Reports history of Haemetaemesis, Melaena and Anaemia
- •6) Reports any presence or history of Gastric Carcinoma.
- •7) Reports history of Zollinger-Ellison syndrome
- •8) Active alcohol or drug abuse that would interfere with study participation.
- •9) Reports a history of drug or alcohol addiction or abuse within the past 1 year.
- •10) Reportâ??s history of Major surgery to the gastrointestinal tract, liver, or kidney within 3 months
- •prior to study entry which may affect the pharmacokinetics of the Study drug.
- •11) Reports a history of allergic asthma
- •12) Reportâ??s organ or tissue transplant
- •13) Reports history of psychiatric disorders including eating disorders.
- •14) Reports history of esophageal varix (varices)
- •15) Reports autoimmune disorder (e.g., lupus, rheumatoid arthritis, multiple sclerosis, etc.)
- •16) Participants administered with H2 receptor antagonists, muscarinic receptor antagonists,
- •gastrin receptor antagonist, proton pump inhibitors, prostaglandins, or mucosal protective
- •agents prior to study in 1 week.
- •17) Reports any presence or history of a clinically significant disorder involving the
- •cardiovascular, respiratory, urologic, gastrointestinal, hepatic, immunologic, hematologic,
- •endocrine, or neurologic system(s) or psychiatric disease as determined by the investigator(s).
- •18) Known history of hepatitis B and/or Hepatitis C virus.
- •19) History of HIV or any immune deficient conditions.
- •20) Able to understand aims and constraints of study and complete self-evaluation Subject diary
- •21) Reportâ??s history of participation in another clinical study within the past three months.
研究者
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