trial protocol

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2 Introduction 2.1 Investigational medicinal product Agar-agar is commonly used as one of food ingredients among Asian countries such as China, Japan and the Republic of Korea. About 94% of agar-agar is dietary fibre and its consistents of agar-agar are agarose and agaropectine, which appear in a ratio of seven to three. In this study, powdered agar-agar is engaged because of its availability, particle size and better solubility. 2.2 Background (400 words) Constipation is frequently seen among haemodialysis patients. Considerable causes of patients’ constipation are nutrient deficiencies specifically dietary fibre, fluid intake, and basal food and energy intake shortage since patients required to following dietary recommends which includes several dietary restrictions. Potassium restriction of end-stage chronic dialysis patients tends to cause lack of vegetable intake, which causes vitamins and dietary fibre shortages. Dietary fibre is suggested as it supports regular execrations. Furthermore, diabete which is one of the biggest cause of renal failure, is also a risk of constipation, hence dialysis patients are often fall into constipation. In addition, fluid intake restriction is one of the biggest concerns of haemodialysis patients since excessive fluid intake can cause cardiovascular events. Although it is strongly linked with sodium intake as water is drawn when sodium intake is high, patients are also required to abandon their fluid intake from preferences such as a cup of tea in the afternoon. Defecating has a role of drainage and excretion schemes include phosphorous and water for dialysis patients since continuous haemodialysis patients do not have effective urination. Therefore natural and regular defecation is i... ... middle of paper ... ...ity, defecation, stool consistency and any other physical events and notes. 8 Statistical Considerations 8.1 Sample size and analysis 8.1.1 Sample size calculation The safety incidences or toxicity of this material is low, since agar is generally used as a food ingredient or a food additive. Significance is assumed in 10% and significance level in 10% and power 80% were used for sample size calculation. Thus, the sample size of 25 was assumed. 8.1.2 Primary endpoint analysis Obtained data will be analysed using Microsoft Excel 2008. The significance of this study will be estimated from frequency of contraptions and use of laxatives. Descriptive analysis will be employed to summarise the data and significances between control term and treatment term will be tested using analysis of variance by paired t-test. P<0.05 will be considered as existence of significance.
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