Evaluation of efficacy and safety of Constipation Formulation in the management of Constipation in Children: A prospective, randomised, double-blind, single center, placebo-controlled, interventional study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Stool frequency documented in the CRF at baseline, day 7 and day 14 (values and change from baseline - within the group and between the groups comparisons)
研究概览
简要总结
Constipation is one of the most common gastrointestinal problem, affecting up to 30% of the children, and have a significant impact on health care use, resulting in tremendous social and economic burden. It is a common paediatric healthcare problem worldwide, with reported prevalence ranging from 0.7 and 29.6 %. It is characterized by infrequent bowel movements or difficulty with evacuation of stools and is associated various symptoms including hard and/or large stools, painful defecation, and faecal incontinence, and is often accompanied by abdominal pain. The prevalence of constipation including infants and adolescents ranges between 10% and 23% in North and South America, while in Europe (only including children) figures between 0.7% and 12% are reported. In Asia, the prevalence is estimated between 0.5% and 29.6%. The prevalence varies according to age groups. The peak incidence of constipation occurs between 2 and 4 years of age. Causes of constipation can be categorized as primary (slow transit or outlet obstruction) or secondary causes. Secondary causes can include simple dehydration or inadequate fluid intake, metabolic disturbances, medications, neurological disorders, failure to respond to urge to defecate, myopathic disorders and structural abnormalities. There are a wide variety of prevention and treatment strategies, which can significantly improve the quality of life in children. However, there is no data concerning the maximum dosage, course of treatment and long-term adverse effects of the administered medications in treating childhood constipation, therefore, the current treatment is symptomatic and largely dependent on clinical experience of health care providers. Nowadays, due to the importance of safety and desire for lowered costs, there is greater attention placed on nutraceutical product as therapies. Nutraceutical products have been demonstrated to be consistently reliable in treatment and prevention of various diseases. They have also recently become a focus of researchers in the development and preparation of new drugs. Particularly, their active ingredients can have antioxidant activities and therapeutic effects and have been used in the treatment of many diseases, including and especially constipation in children. Therefore, the objective of the current study is to determine the effect of nutraceuticals on management of constipation in children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 3.00 Year(s) 至 16.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female children aged ≥3 to ≤16 years.
- •Duration of constipation more than 4 weeks.
- •Presence of ≥2 of the following: a.
- •defecation frequency ≤2 times per week b.
- •faecal incontinence ≥1 time per week c.
- •history of painful or hard bowel movements e.
- •presence of a large mass in the rectum or on per abdomen examination f.
- •history of large-diameter stools that may obstruct the toilet (if information available)
- •Children willing to provide informed assent if applicable.
- •Child’s parent/guardian/legally acceptable representative willing to provide informed written consent.
排除标准
- •Presence of other organic disorders which might be cause of constipation.
- •Children suffering from irritable bowel syndrome
- •Children with hormonal diseases
- •Children who have received other treatments for constipation in the past 48 hours.
- •Children who are planned to be treated through disimpaction.
- •Current or past history of a serious illness including, seizures, major psychiatric illness, structural brain disease, liver or kidney failure, organ transplantation, rheumatoid arthritis, uncontrolled hypertension, uncontrolled diabetes or malignancy, cardiovascular event in the last three months.
- •Allergy or sensitivity to any of the ingredients in the study treatment.
- •Subjects who have participated in other clinical studies during the past 3 months or subjects who intend to participate in other clinical studies parallelly.
- •Subjects with any other illness or health condition which in the opinion/medical judgement of the study investigator makes the subject ineligible to participate in the study.
结局指标
主要结局
Stool frequency documented in the CRF at baseline, day 7 and day 14 (values and change from baseline - within the group and between the groups comparisons)
时间窗: baseline, day 7 and day 14
次要结局
- Symptomatic change in fecal incontinence documented in the CRF baseline, day 7 and day 14 (values within the group and between the groups comparisons)(baseline, day 7 and day 14)
- Symptomatic change in abdominal pain documented in the CRF baseline, day 7 and day 14 (values within the group and between the groups comparisons)(baseline, day 7 and day 14)
- Stool consistency documented in the CRF baseline, day 7 and day 14 (values within the group and between the groups comparisons)(baseline, day 7 and day 14)
- Weight gained post treatment documented in the CRF baseline, day 7 and day 14 (values and change from baseline - within the group and between the groups comparisons)(baseline, day 7 and day 14)