Unique ID issued by UMIN | UMIN000041167 |
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Receipt number | R000047009 |
Scientific Title | Efficacy of perioperative Ninjin-yoei-to administration for skeletal muscle mass and weight loss after gastrectomy for gastric cancer: a randomised open-label trial |
Date of disclosure of the study information | 2020/08/01 |
Last modified on | 2023/09/12 16:19:05 |
Efficacy of perioperative Ninjin-yoei-to administration for skeletal muscle mass and weight loss after gastrectomy for gastric cancer: a randomised open-label trial
Efficacy of perioperative Ninjin-yoei-to administration for skeletal muscle mass and weight loss after gastrectomy for gastric cancer: a randomised open-label trial
Efficacy of perioperative Ninjin-yoei-to administration for skeletal muscle mass and weight loss after gastrectomy for gastric cancer: a randomised open-label trial
Efficacy of perioperative Ninjin-yoei-to administration for skeletal muscle mass and weight loss after gastrectomy for gastric cancer: a randomised open-label trial
Japan |
gastric cancer
Gastrointestinal surgery |
Malignancy
NO
To clarify the efficacy of perioperative Ninjin-yoei-to administration for skeletal muscle mass and weight loss after gastrectomy for gastric cancer
Efficacy
Change rate of skeletal muscle mass and body weight 1, 3 and 6 months after gastrectomy
Perioperative systemic inflammation markers, body composition analysis, grip strength, postoperative complications, surgery-related death
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
No treatment
YES
2
Treatment
Medicine |
The arm of Ninjin-yoei-to.
Take 2.5 g of Ninjin-yoei-to before each meal or between meals. The oral period will be from 2 weeks before surgery to 24 weeks after surgery.
Do not take Ninjin-yoei-to.
20 | years-old | <= |
Not applicable |
Male and Female
1) Patients who are admitted to outpatient department of gastroenterology or general surgery at Showa University Fujigaoka Hospital
2) Patients with histologically confirmed gastric cancer
3) Patients with clinical progress I to III who meet the indication for gastrectomy according to the 5th edition of the Guideline for Gastric Cancer Treatment
4)Patients who are 20 years or older and have PS0 or 1 at the time of obtaining consent
5)Patients who gave their informed consent to participate in this trial
1) Patients with residual gastric cancer
2) Patients with gastrointestinal obstruction due to tumor
3) Patients who received preoperative chemotherapy or radiation therapy for gastric cancer
4) Patients who perform simultaneous resection of other organs other than gallbladder
5) Patients with infectious diseases that require systemic treatment
6) Patients who have comorbidies, or who are taking oral medication that interferes with the determination of efficacy in measuring the number of white blood cells and lymphocytes.
7) Patients with serious liver/renal disorders or cardiopulmonary diseases that may affect the safety evaluation of drugs
8) Patients who have been given Chinese herbal medicines 4 weeks before the start of the study
9)Patients who have a history of allergy to herbal medicine
10) Patients who are judged to be ineligible by the research doctor
40
1st name | tsuneyuki |
Middle name | |
Last name | uchida |
Showa University Fujigaoka Hospital
Department of Gastroenterological and General Surgery
2278501
1-30, Fujigaoka, Aoba-ku, Yokohama, kanagawa 2278501 JAPAN
045-971-1151
t_uchida@med.showa-u.ac.jp
1st name | tsuneyuki |
Middle name | |
Last name | uchida |
Showa University Fujigaoka Hospital
Department of Gastroenterological and General Surgery
2278501
1-30, Fujigaoka, Aoba-ku, Yokohama, kanagawa 2278501 JAPAN
045-971-1151
t_uchida@med.showa-u.ac.jp
Showa University Fujigaoka Hospital
Department of Gastroenterological and General Surgery
Self funding
Self funding
Showa University Fujigaoka Hospital Clinical trial Review Board
1-30, Fujigaoka, Aoba-ku, Yokohama, kanagawa 2278501 JAPAN
045-974-6329
f-irb@cmed.showa-u.ac.jp
NO
昭和大学藤が丘病院(神奈川県)
2020 | Year | 08 | Month | 01 | Day |
Unpublished
40
The results showed no significant differences in any of the items between the two groups. The results of this study did not indicate the efficacy of perioperative Ninjinyoeito on weight and skeletal muscle loss after gastric cancer surgery.
2023 | Year | 09 | Month | 12 | Day |
Of the patients who underwent gastrectomy for a diagnosis of gastric cancer between 2020 and 2023, 40 patients who consented to the study were enrolled. 39 patients were included in the study, excluding one patient who met the postoperative exclusion criteria. 19 patients were allocated to the Ninjinyoeito group and 20 to the control group. No significant differences were found in patient background. All patients underwent body composition measurements (body weight, SMI, visceral fat) preoperatively and at 1, 3 and 6 months postoperatively.
Completed
2020 | Year | 07 | Month | 07 | Day |
2020 | Year | 07 | Month | 07 | Day |
2020 | Year | 08 | Month | 01 | Day |
2023 | Year | 03 | Month | 31 | Day |
2023 | Year | 03 | Month | 31 | Day |
2023 | Year | 03 | Month | 31 | Day |
2023 | Year | 03 | Month | 31 | Day |
2020 | Year | 07 | Month | 20 | Day |
2023 | Year | 09 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047009
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