ITMCTR2200005597尚未招募4 期
A multicenter, randomized, double-blind, placebo-controlled exploratory clinical trial for efficacy and safety of Simo Decoction in the treatment of functional constipation (qi stagnation)
适应症
试验速览
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational study
入排标准
- 年龄范围
- 18 至 65（—）
- 性别
- All
入选标准
- •(1) Meet the western and Chinese diagnostic criteria for functional constipation (qi stagnation);
- •(2) Those aged between 18 and 65 (both ends included);
- •(3) Less than 3 times a week of fully spontaneous defecation;
- •(4) Colonoscopy results were generally normal;
- •(5) The subject is informed and voluntarily signs the informed consent;
- •(6) Resident in local area, able to guarantee treatment follow-up, with certain reading ability.
排除标准
- •(1) constipation caused by organic diseases (such as colon tumor, intestinal stenosis or obstruction, etc.);
- •(2) endocrine and metabolic diseases such as diabetes and hypothyroidism;
- •(3) drug-related constipation (such as opioids, etc.);
- •(4) Patients with serious lesions of heart, liver and kidney, hematopoietic system diseases, nervous system diseases, muscle diseases and other system tumors;
- •(5) have a history of mental illness (such as severe depression, severe anxiety);
- •(6) Pregnant or lactating women who had a birth plan from enrollment to 1 month after the end of the study;
- •(7) suspected or confirmed history of alcohol or drug abuse;
- •(8) allergic to the test drug, emergency drug and its ingredients;
- •(9) Patients who have participated in other clinical trials or are currently participating in other clinical trials within 1 month prior to inclusion;
- •(10) the investigator considers it inappropriate to conduct clinical trials.
研究者
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