CTRI/2023/07/055098尚未招募2 期
An open single arm, single centric phase II clinical trial to evaluate the effectiveness of Malakudaara Mezhugu in the management of Kattu Mantham (Functional Constipation) in children - Nil
Ayothidoss Pandithar Hospital, Ayothidoss Pandithar Hospital0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
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
- •Children with minimum two of the following clinical symptoms for atleast three month (Based on Rome IV criteria for Functional Constipation)
- •1) Straining during more than one-fourth (25%) of defecations
- •2) Lumpy or hard stools (Bristol Stool Form Scale 1 or 2) more than one-fourth (25%) of defecations
- •3) Sensation of incomplete evacuation more than one-fourth (25%) of defecations
- •4) Sensation of anorectal obstruction/blockage more than one-fourth (25%) of defecations
- •5) Manual maneuvers to facilitate more than one-fourth (25%) of defecations (such as digital evacuation, or support of the pelvic floor)
- •6) Fewer than 3 Spontaneous Bowel Movements per week
- •7) Patientâ??s informant / Parent willing to sign the informed consent.
排除标准
- •1) Intolerance to the drug and development of adverse reactions such as nausea, vomiting, abdominal discomfort during trial period.
- •2) Poor patient compliance & defaulters.
- •3) Patient turned unwilling to continue in the course of clinical trial.
- •4) Aggravation of symptoms.
研究者
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