Unique ID issued by UMIN | UMIN000049830 |
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Receipt number | R000056747 |
Scientific Title | Effects of consumption of the test food on the bowel movement in healthy Japanese subjects who tend to have loose stools: a randomized, placebo-controlled, double-blind, parallel-group comparison study |
Date of disclosure of the study information | 2022/12/19 |
Last modified on | 2024/02/15 18:02:11 |
Effects of consumption of the test food on the bowel movement in healthy Japanese subjects who tend to have loose stools
Effects of consumption of the test food on the bowel movement in healthy Japanese subjects who tend to have loose stools
Effects of consumption of the test food on the bowel movement in healthy Japanese subjects who tend to have loose stools: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Effects of consumption of the test food on the bowel movement in healthy Japanese subjects who tend to have loose stools
Japan |
Healthy Japanese subjects
Not applicable | Adult |
Others
NO
To verify the effects of consumption of the test food on the bowel movement in healthy Japanese subjects who tend to have loose stools
Efficacy
Confirmatory
Pragmatic
Not applicable
1. The defecation frequency in period 6*
*Period 6: The 4th week after consumption of the test food
1. The defecation frequency in period 3, 4, and 5
2. The numbers of defecation days and amount of defecation in period 3, 4, 5, and 6*
3. The rate of each state for stool shape, stool smell, and exhilarating feeling of defecation in period 3, 4, 5, and 6*
4. Frequency of defecation desire, feeling of defecation desire, and feeling of defecation urgency measured by visual analogue scale (VAS) at four weeks after consumption (4w)
5. Water content in stool, each score of the Gastrointestinal Symptom Rating Scale (GSRS) (total score, Reflux, Abdominal pain, Indigestion, Diarrhoea, and Constipation), and each score of the MOS Short-Form 36-Item Health. Survey (SF-36) {Physical Component Summary (PCS), Mental Component Summary (MCS), Role-social Component Summary (RCS), Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, Mental Health} at 4w
*Period 1: Seven days prior to screening (before consumption: Scr)
Period 2: Seven days prior to the initial day to consume the test food
Period 3: The 1st week after consumption of the test food
Period 4: The 2nd week after consumption of the test food
Period 5: The 3rd week after consumption of the test food
Period 6: The 4th week after consumption of the test food
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
Institution is not considered as adjustment factor.
YES
2
Treatment
Food |
Duration: Four weeks
Test food: Ginger capsule
Administration: Take one capsule in the morning
*If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day.
Duration: Four weeks
Test food: Placebo capsule
Administration: Take one capsule in the morning
*If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day.
18 | years-old | <= |
Not applicable |
Male and Female
1. Japanese
2. Men or women
3. Adults
4. Healthy subjects
5. Subjects who do not have abdominal pain or whose abdominal pain subsides for less than one day per week within three months before briefing
6. Subjects who have loose stools at least three days per week and repeat for the last two months
7. Subjects whose defecation frequency a week prior to Scr is between 10 to 20
8. Subjects whose stool shape of all defecation a week prior to Sc are "4," "5," or "6"*
*4: "Like a sausage and smooth surface"
5: "Soft blobs with clear cut edges"
6: "A mushy stool with ragged edges"
1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction
2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. Subjects currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. Subjects who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily
5. Subjects who are currently taking medications (including herbal medicines) and supplements
6. Subjects who are allergic to medicines and/or the test food related products
7. Subjects who are pregnant, lactating, or planning to become pregnant during this trial
8. Subjects who suffer from COVID-19
9. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial
10. Subjects who are judged as ineligible to participate in this study by the physician
30
1st name | Tsuyoshi |
Middle name | |
Last name | Takara |
Medical Corporation Seishinkai, Takara Clinic
Director
141-0022
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
03-5793-3623
t-takara@takara-clinic.com
1st name | Naoko |
Middle name | |
Last name | Suzuki |
ORTHOMEDICO Inc.
R&D Department
112-0002
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
03-3818-0610
nao@orthomedico.jp
ORTHOMEDICO
Ikeda Food Research Co.,Ltd.
Profit organization
Medical Corporation Seishinkai, Takara Clinic
Nerima Medical Association, Minami-machi Clinic
the ethical committee of the Takara Clinic, Medical Corporation Seishinkai
9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
03-5793-3623
IRB@takara-clinic.com
NO
医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)
2022 | Year | 12 | Month | 19 | Day |
Unpublished
32
Completed
2022 | Year | 11 | Month | 16 | Day |
2022 | Year | 11 | Month | 16 | Day |
2022 | Year | 12 | Month | 19 | Day |
2023 | Year | 03 | Month | 12 | Day |
2022 | Year | 12 | Month | 19 | Day |
2024 | Year | 02 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056747
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