A Double Blind, placebo controlled, Clinical study to evaluate the efficacy and safety of Ginger caplets in Post operative nausea and vomiting
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- symptomatic relief from clinical symptoms of post operative nausea and vomiting
研究概览
简要总结
Onlysubjects who meet the subject selection section, have signed an informedconsent form and have an updated medical history on file with the investigatorwill be entered into the study. As per the random number table the subject will receive either Ginger caplet or placebo at a dose of 1 caplet twice daily for the period of 10 days.
Subjectiveand objective evaluation will be done. Assessmentwill be done on entry, at the end of 3rd day, 6th day, 10th day. Adverse effects as volunteered by the patients will be noted in theCRFs. Information on each patient will be collected from their history,General physical examination, systemic examination and laboratory investigations, and will be recorded on theCase Report Form.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢Patients who are posted for abdominal surgery, hernia, orthopedic and gynecological surgeries and also those patients presenting with Post operative nausea & vomiting.
- •â€¢Patients willing to sign informed consent.
排除标准
- •â€¢Patients with severe vomiting related to CNS or severe gastrointestinal disorders.
- •â€¢Any evidence or history of hypersensitivity to herbal medicines.
- •â€¢Not willing to sign the informed consent or abide by the study procedure.
- •â€¢Pregnant or lactating women.
结局指标
主要结局
symptomatic relief from clinical symptoms of post operative nausea and vomiting
时间窗: Assessment is done at entry day 3 day 6 and day 10
次要结局
- To assess the safety profile of Ginger caplets and overall compliance(Assessment is done at entry day 3 day 6 and day 10)