A study of the usefulness of Ninjinyoeito for hypotrophic patients
- Conditions
- Hypotrophic
- Registration Number
- JPRN-jRCTs031210674
- Lead Sponsor
- Asaoka Daisuke
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 20
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
1) Surgical resection of the stomach, gall bladder, small intestine, or large intestine except for appendicitis
2) Obese
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Amount of change in CONUT score from baseline at 12 weeks of treatment
- Secondary Outcome Measures
Name Time Method 1) Rate of change in CONUT<br>2) Amount of change in SNAQ<br>3) Amount of in GNRI<br>4) Amount of change in serum albumin<br>5) Amount of change in prealbumin<br>6) Amount of change in body weight<br>7) Amount of change in BMI<br>8) Amount of change in Izumo scale<br>9) Amount of change in EAT-10