TCTR20221007001尚未招募1 期
Efficacy and Safety of Salol et Menthol Mixture versus Oral Rehydration Salts (ORS) Solution for Treatment of Patients with Acute Watery Diarrhea; An Observer-Blinded, Randomized Controlled, Pilot Study
Boss Pharmacare Co., Ltd.0 个研究点目标入组 30 人开始时间: 2022年10月7日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
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
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- All
入选标准
- •1.Thai Male/Female (should balance in both gender) age between 18-55 years.
- •2.Presenting with acute watery diarrhea (defined as 3 or more watery stools (BSFS 6-7) per day) for not more than 72 hours.
- •3.Presenting with at least two or more associated symptoms including flatulence, upset stomach and abdominal pain
- •4.Have the ability to understand the requirements of the study and must voluntarily sign and date an informed consent, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), prior to the initiation of any screening or study-specific procedures
排除标准
- •1.Known or suspected hypersensitivity to phenyl salicylate (salol) and menthol.
- •2.Patient has a history of any illness that, in the opinion of principal investigator or designated physicians, might confound the result of the study or pose an additional risk in administering treatment to the patient. This may include but is not limited to: a history of relevant drug or food allergies; history of cardiovascular, gastrointestinal, central nervous system disease, renal and hepatic impairment; history or presence of clinically significant illness; or history of mental illness that may affect compliance with study requirements.
- •3.Suffering from diarrhea as a result of antibiotic treatment, food allergies, ingestion of laxatives (72 hours prior to this assessment)
- •4.Presenting symptoms of irritable bowel syndrome (IBS)
- •5.Presenting body temperature more than 38.5 C; antipyretic medication should not have been administered in the 6 hours prior to this assessment)
- •6.Presenting with grossly/mucous bloody stool
- •7.Presenting with moderate or severe dehydration (i.e. symptoms of hypovolemia such as orthostatic hypotension, dizziness or wrinkling of skin)
- •8.Administration of anti-diarrhea product including antibiotics and drug that affect the gastrointestinal tract for this diarrhea episode (e.g. prokinetic drug and anticholinergic drug)
- •9.Treatment with investigational product within 30 days before screening
- •10.Participation in any investigation drug study within 1 month from screening (from the last follow-up visit to the screening)
- •11.Pregnancy (confirmed by interviewing)
研究者
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