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【ChiCTR2100043200】Efficacy and Safety of Chinese Herbal Formula MZWD CDD-2103 for Remission Maintenance of Ulcerative Colitis: A Randomized, Double-blinded, Placebo-controlled Trial

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基本信息

登记号

ChiCTR2100043200

试验状态

尚未开始

药物名称

药物类型

规范名称

首次公示信息日的期

2021-02-08

临床申请受理号

靶点

适应症

Ulerative Colitis

试验通俗题目

Efficacy and Safety of Chinese Herbal Formula MZWD CDD-2103 for Remission Maintenance of Ulcerative Colitis: A Randomized, Double-blinded, Placebo-controlled Trial

试验专业题目

Efficacy and Safety of Chinese Herbal Formula MZWD CDD-2103 for Remission Maintenance of Ulcerative Colitis: A Randomized, Double-blinded, Placebo-controlled Trial

申办单位信息

申请人联系人

申请人名称

联系人邮箱

联系人邮编

联系人通讯地址

临床试验信息

试验目的

The aim of this study is to evaluate the efficacy and safety of CHM formula MZWD CDD-2103, compared with the placebo, for remission maintenance in patients with UC.

试验分类

试验类型

随机平行对照

试验分期

探索性研究/预试验

随机化

A computer-generated random list for the centre-stratified method and permuted block size created by SPSS 25.0 software will be used for randomization. Participants will be randomly assigned to either MZWD CDD-2103 formula group or placebo group with a 1:1 allocation. The block sizes will not be disclosed, to&#

盲法

Participant and investigators (including statisticians) will be blinded to group allocation throughout the research. To ensure blinding, the MZWD CDD-2103 formula and the placebo will be identical in all aspects (e.g., appearance, size, color, smell, taste, containers, and doses).

试验项目经费来源

Health@InnoHK Initiative Fund of the Hong Kong Special Administrative Region Government (ITC RC/IHK/4/7)

试验范围

目标入组人数

实际入组人数

第一例入组时间

2021-02-01

试验终止时间

2024-12-31

是否属于一致性

入选标准

Patients eligible for the trial must comply with all of the following at randomization: 1. Aged 18-65 years. 2. The diagnostic criteria for clinical remission of UC at least 3 months prior to study entry. Clinical remission is defined as Mayo score of less than or equal to 2 with no individual subscore greater than 1. 3. The diagnostic criteria for spleen deficiency with dampness obstruction, which can be diagnosed on the basis of any two main symptoms and two secondary symptoms, with reference to the tongue and pulse, as follows: main symptoms include loose stool (with mucus or not); diarrhea and loose stool with undigested food; and distended abdomen. Secondary symptoms include abdominal vague pain; physical fatigue and heavy; poor appetite or anorexia; and mental fatigue and lazy talk. Light red tongue with edge teeth marks and thin white greasy coasting; as well as thready and weak pulse or thready and slippery pulse. 4. Normal liver and renal function in blood test within 3 months. 5. Individuals should fully understand what is involved in this study and give documented consent to participate in the study.；

排除标准

Patients who meet one of the following criteria will be excluded: 1. The presence of active UC within 90 days before eligibility determination. 2. Abnormal colonoscopy and biopsy pathology report, such as crypt epithelial dysplasia (intraepithelial neoplasia) or cancerous. 3. Intestinal stenosis. 4. Infectious enteritis or any suspicion of the presence of infectious enteritis (e.g., present of positive in the clostridium difficile test). 5. Individual who has been taken biological drugs or antibiotics within the last three months. 6. Aparotomy or laparoscropic surgery, surgery for hemorrhoids or perianal abscess, endoscopic mucosal resection or endoscropic intestinal dilation or endoscopic intestinal dilatation of the colon within 60 days before eligibility determination. 7. History of resection of the small intestine, cecum, colon or rectum. 8. Individuals with moderate or severe hepatic or renal disease abnormalities. 9. Individuals with any serious comorbid disease, such as hematological, respiratory, cardiovascular, or neuropsychiatric disease, or metabolic/electrolyte abnormality. 10. Individuals undergoing treatment or follow-up under 5 years for a malignant tumor. 11. History of allergy to Chinese herbal medicine (e.g., G6PD deficiency). 12. History of alcohol or drug abuse. 13. Pregnant and nursing women and women suspected of being pregnant. 14. Individuals who are participating in any other clinical researches at study entry. 15. Others whom the investigator or co-investigator considered to be inappropriate for enrollment.；

研究者信息

研究负责人姓名

试验机构

香港浸會大學賽馬會中醫藥學院

研究负责人电话

研究负责人邮箱

研究负责人邮编

联系人通讯地址

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