CTRI/2017/03/008052已完成3 期
A Prospective, Open-label, Multicenter, Phase 3 Study to Assess the Acceptability of and Adherence to a 10-Day Regimen of Zinc Sulphate Dispersible Tablets for Treatment of Acute Childhood Diarrhea. - ZNDT
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 129
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
- •Subject with acute diarrhea (3 or more loose, liquid, or watery stools in past 24 hours).
- •Subject must be healthy except for study-related disease condition in the opinion of the
- •Investigator.
- •Subjectâ??s parent/guardian should be ready to comply with the study procedures and adhere to the prohibitions and restrictions specified in the protocol.
- •Subjectâ??s parent/guardian willing to sign an ICF indicating that they have understood the purpose of and procedures required for the study, and are willing for their childâ??s participation in the study.
排除标准
- •Subject with pedal edema or who is severely dehydrated e.g. abnormally sleepy or lethargic, sunken eyes, drinking poorly or not at all, tachycardia, tachypnea, markedly reduced skin turgor; and require hospitalization.
- •Subject with co-morbidity associated with excessive vomiting, e.g., whooping cough, pylorospasm, congenital pyloric stenosis, hiatus hernia, other obstructive defects of the gastrointestinal tract or a history of cowâ??s milk allergy, etc.
- •Subject with any other known systemic complication, e.g. pneumonia, meningitis, sepsis, paralytic ileus, severe malnutrition, hypoglycemia, serum electrolyte disorders, seizure that require admission to the hospital.
- •Subject with chronic or persistent diarrhea and dysentery, had developmental delay ( >1 year behind milestones), or having a birth defect or having a medical condition that could interfere with the ability to discriminate taste, e.g., common cold or a sinus or bronchial infection.
- •Subject already on zinc supplementation, zinc fortified infant formulae, or receiving drugs that may inhibit zinc absorption such as iron supplements, penicillamine, sodium valproate, and ethambutol.
- •Subject who has taken prescription drugs other than those prescribed for diarrhea during the preceding 24 hours.
- •Subject with hypersensitivity to zinc or has known food or drug allergies to any of the constituents of the study drug product.
- •Subject who has participated in any other clinical study within past 30 days or has participated in a similar study for zinc sulphate earlier.
研究者
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