ITMCTR2200005569尚未招募未知
A randomized, double-blind, double-simulation, parallel control with positive drugs, multicenter clinical trial of Xuening tablet in treating iron deficiency anemia (deficiency of both qi and blood).
Dongzhimen Hospital Beijing University of Chinese Medicine0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 年龄范围
- 18 至 75（—）
- 性别
- All
入选标准
- •(1) Age between 18 and 75 years old, male or female;
- •(2) Meet the diagnostic criteria of iron deficiency anemia;
- •(3) TCM syndrome differentiation is deficiency of both qi and blood;
- •(4) Male 80g/L= hemoglobin (HB) < 120g/L, female 80g/L= hemoglobin (HB) < 110g/L;
- •(5) The informed consent of the subjects and the voluntary signing of the informed consent form.
排除标准
- •(1) Anemia other than iron deficiency anemia, such as thalassemia;
- •(2) Anemia caused by lead poisoning, inflammation and other diseases;
- •(3) Those who use the following drugs within 2 weeks before obtaining the random drug number and cannot stop using them (including drugs containing iron, such as ferrous fumarate, ferric ammonium citrate, etc.); Chemicals with similar efficacy to other test drugs that directly affect the evaluation index, such as vitamin B1 and vitamin B2; Chinese patent medicines, such as Yiqi Buxue oral liquid, Yiqi Yangxue granules, etc. Chinese medicine, such as codonopsis pilosula, ginseng, radix Pseudostellariae, donkey-hide gelatin, angelica, white peony root, poria cocos, etc.);
- •(4) Patients with severe primary diseases such as heart, liver and kidney, whose liver function alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are higher than the upper limit of normal reference value by 1.5 times, and whose creatinine (Cr) is higher than the upper limit of normal reference value;
- •(5) Pregnant women, women who plan to be pregnant within 6 months and lactating women;
- •(6) People with allergic constitution and a history of allergic reaction to the known components of this drug;
- •(7) Those who cannot correctly express their own symptoms;
- •(8) Patients who have participated in other clinical trials or are participating in clinical trials of other drugs in the last month;
- •(9) Because the control drug contains pig blood extract, this study excluded the subjects who could not participate in this study due to religious beliefs;
- •(10) The researcher judges that it is not suitable to participate in this researcher.
研究者
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