Effects of Renzhuchangle grannule on diarrhoea-predominant irritable bowel syndrome: a randomised, double-blind, placebo-controlled phase IIa study

Purapharm (Nanning) Pharmaceuticals Co. Limited0 个研究点目标入组 108 人开始时间: 2018年11月30日最近更新: 2023年2月13日

试验速览

暂无简介。

•1. Diarrhoea-predominant irritable bowel syndrome (IBS-D) meeting the Rome IV criteria
•2. Meeting the Traditional Chinese Medicine syndrome of liver-depression and spleen-deficiency criteria
•3. Aged 18 to 65
•4. Voluntary acceptance of the medication
•5. Signed informed consent
•6. Average daily worst abdominal pain score =3 during the last week of screening phase
•7. More than two days of =1 loose stools (Bristol Stool Scale 6 or 7) during the last week of screening phase

•1. Prior abdominal surgery which may cause bowel symptoms similar to IBS
•2. Diarrhoea as a result of any of the following:
•2.1. Infection
•2.2. Systemic diseases
•2.3. Poisoning
•2.4. Cancer
•3. Serious concomitant diseases, including cardiovascular, renal, hepatic, respiratory, neurological, endocrine or haematopoietic diseases
•4. History of alcohol or drug abuse
•5. Allergic constitution or known to be allergic to the drug used in this trial
•6. Involved in other trials
•7. Pregnant or breastfeeding, or plan to become pregnant soon
•8. Poor compliance or any other reason the research believers they may not be appropriate to participate in this trial

发起方

Purapharm (Nanning) Pharmaceuticals Co. Limited