CTRI/2013/10/004116招募中2 期
Validation of Unani Pharmacopoeial formulation in Kasrat- e- Ratubat-e-Hamoozi (Hyperacidity)
Central Council for Research in Unani Medicine CCRUM New Delhi3 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2011年2月11日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 3
- 主要终点
- Improvement in signs and symptoms
研究概览
简要总结
This study is designed as a multicentric open trial in patients with Kasrat- e- Ratubat-e-Hamoozi (hyperacidity). After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically on each fortnightly follow up. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be 06 weeks. . Laboratory parameters for safety assessment will be conducted at baseline and end of study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 16.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢Subjects in the Age group of 18-60 years •Subjects of both sexes •Subjects presenting with the following symptoms : oRetrosternal burning oEpigastric pain with retrosternal heaviness oAcidic brash oAnorexia oNausea oVomiting oPain relieved after vomiting.
排除标准
- •â€¢Duodenal ulcer •Peptic ulcer •H/o previous gastric surgery •Presence of cardiac & lung diseases •Pregnancy/lactation •Alcoholism •Diabetes •Stomach carcinoma •Crohn’s Diseases •Allergy/Intolerance to any ingredients of the drug1,9,
- •â€¢Zollinger Ellison Syndrome.
结局指标
主要结局
Improvement in signs and symptoms
时间窗: 6 WEEKS
次要结局
- Outcome TimePoints(Hematological and biochemical assessments for safety)
研究者
研究点 (3)
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