Project 3 - A Dose-Ranging Study of Chinese Herbal Medicine in Treating Patients

肠易激综合征（IBS），以腹痛/不适和紊乱为特征 肠频率，是一种常见的功能性肠病，占相当大比例的患者 在初级保健和二级转诊中心看到。对患者生活质量和经济的影响 对社会的负担是相当大的。然而，传统西医在 治疗IBS令人失望。几种潜在的新治疗药物已被撤回 因为严重的不良事件。传统中药（TCM）已用于治疗 在亚洲国家已有数百年的历史，但对其治疗作用的科学评价却很少。近日一 一个方法学上强有力的试验20草药配方显示显着的好处肠易激综合征患者。但 草药配方没有充分的特征和定义用于重复的临床研究。 项目总结：完成化学表征（植物核心）后，我们将进行 一项随机、安慰剂对照、双盲、II期剂量递增临床试验，旨在寻找最佳安全性 对117例年龄在18 ~ 75岁的各种类型的患者进行了20味中药标准化制剂的有效剂量和有效剂量的研究 的IBS。在三个剂量水平中的每一个下，39名参与者将被随机分配至治疗8周， 以2：1的分配比例，将在基线、第0、2、4、8和12周进行评估 患者报告的总体症状改善的临床重要和可靠结局。在 第1和第2剂量水平结束后，将在新的研究中使用更高剂量之前评估安全性。 一群参与者。我们还将评估个体IBS症状、性质、严重程度、持续时间和频率。 不良事件、生活质量、伴随IBS药物和医疗保健利用，并将执行 血液检测是为了安全起见。将通过药丸计数验证研究药物依从性。成果 剂量范围研究将有助于确定未来使用的草药配方的最佳剂量 随机安慰剂对照试验以及与传统药物的头对头比较。

Irritable bowel syndrome (IBS), characterized by abdominal pain/discomfort and disturbed bowel frequency, is a common functional bowel disorder that accounts for a substantial proportion of patients seen in primary care and secondary referral centers. The impact on patients' quality of life and the economic burden on the community are considerable. However, the outcome of conventional Western medicine in reating IBS has been disappointing. Several potential new therapeutic agents have been withdrawn because of serious adverse events. Traditional Chinese medicine (TCM) has been used in the treatment of BS for centuries in Asian countries but scientific evaluation of its therapeutic function is scarce. Recently, a a methodologically strong trial of a 20-herb formula showing significant benefit for IBS patients. However, the herbal formulation is inadequately characterized and defined for repeated clinical studies. PROJECT SUMMARY: Subsequent to complete chemical characterization (Botanical Core), we will conduct a randomized, placebo-controlled, double-blind, phase II dose-escalation clinical trial to find an optimally safe and efficacious dosage of this standardized 20-herb preparation in 117 patients aged 18 to 75 with all types of IBS. At each of three dosage levels, 39 participants will be randomized to treatment for 8 weeks with the herbal formula or placebo in a 2:1 allocation ratio, and will be assessed at baseline, weeks 0, 2, 4, 8, and 12 for the clinically important and reliable outcome of patient reported global symptom improvement. At the conclusion of the 1st and 2nd dosage levels, safety will be assessed prior to using a higher dosage in a new cohort of participants. We also will assess individual IBS symptoms, nature, severity, duration, and frequencv of adverse events, quality of life, concurrent IBS medications and health care utilization, and will perform blood tests for safety purposes. Adherence to study medication will be verified by pill counts. Results of this dose-ranging study will help to identify the optimal dosage of the herbal formula to be used in future randomized placebo-controlled trials and in head-to-head comparisons with conventional Pharmaceuticals.