JPRN-jRCTs031210674已完成未知
A study of the usefulness of Ninjinyoeito for hypotrophic patients with anorexia
Asaoka Daisuke0 个研究点目标入组 20 人开始时间: 2022年3月18日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 20
研究概览
简要总结
An exploratory study was conducted on the efficacy and safety of ninjin-yo-eito in a small number of hypoanorexic patients with anorexia. There was no change in CONUT score, the primary endpoint, before and after treatment, and the efficacy of the study drug could not be confirmed. One patient had anorexia (known, non-serious), which resolved after discontinuation.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 65age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) 65 years old or older
- •2) Outpatients at our hospital who can walk on their own
- •3) Poor nutritional status with CONUT score more than mild and MNA less than 24 points
- •4) Anorexia who score 14 or below on the SNAQ
- •5) Written informed consent
排除标准
- •1) Surgical resection of the stomach, gall bladder, small intestine, or large intestine except for appendicitis
- •3) Celiac disease, inflammatory bowel disease (Crohn's disease or ulcerative colitis), or ischemic colitis
- •4) Infectious enteritis
- •5) Mechanical obstruction, giant colon, or giant rectum
- •6) Malignant tumor of the digestive system except for cured by endoscopic surgery
- •7) Serious cardiovascular, respiratory, renal, hepatic, digestive, hematological, neurological, or psychiatric
- •diseases except for sleeping pills only for insomnia.
- •8) Parkinson's disease
- •9) Hyperthyroidism or hypothyroidism
- •10) Participated in clinical trials, post-marketing clinical trials, or clinical research for other ethical drugs or medical devices within 3 months prior to obtaining consent.
- •11) Abusing alcohol and drugs
- •12) Allergy caused by herbal medicines, including Chinese herbal preparations
- •13) Regularly using other Chinese herbal preparations
- •14) Aldosteronism, myopathy, or hypokalemia
- •15) Inappropriate for participation in this study.
研究者
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