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UMIN-CTR Clinical Trial |
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Name | UMIN ID |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000048594 |
Receipt No. | R000055354 |
Scientific Title | Effects of consumption of the test food on the bowel movement in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study |
Date of disclosure of the study information | 2022/08/04 |
Last modified on | 2022/08/04 |
Basic information | ||
Public title | Effects of consumption of the test food on the bowel movement in healthy Japanese subjects | |
Acronym | Effects of consumption of the test food on the bowel movement in healthy Japanese subjects | |
Scientific Title | Effects of consumption of the test food on the bowel movement in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study | |
Scientific Title:Acronym | Effects of consumption of the test food on the bowel movement in healthy Japanese subjects | |
Region |
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Condition | |||
Condition | Healthy Japanese subjects | ||
Classification by specialty |
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Classification by malignancy | Others | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To verify the effects of consumption of the test food on the bowel movement in healthy Japanese subjects |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | Pragmatic |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | 1. The defecation frequency in period VI*
*Period VI: The 4th week after consumption of the test food |
Key secondary outcomes | 1. The defecation frequency in period III, IV, and V*
2. The numbers of defecation days and amount of defecation in period III, IV, V, and VI* 3. The rate of each state for stool shape, stool smell, and exhilarating feeling of defecation in period III, IV, V, and VI* 4. The score and each item of The Japanese Version of the Constipation Assessment Scale (CAS) 5. Gastrointestinal symptom rating scale (GSRS), MOS Short-Form 36-Item Health. Survey (SF-36), and water content in stool *Period I-II: Before consumption of the test food Period III: The 1st week after consumption of the test food Period IV: The 2nd week after consumption of the test food Period V: The 3rd week after consumption of the test food Period VI: The 4th week after consumption of the test food |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Double blind -all involved are blinded |
Control | Placebo |
Stratification | |
Dynamic allocation | |
Institution consideration | Institution is not considered as adjustment factor. |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | 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. |
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Interventions/Control_2 | 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. |
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Interventions/Control_3 | ||
Interventions/Control_4 | ||
Interventions/Control_5 | ||
Interventions/Control_6 | ||
Interventions/Control_7 | ||
Interventions/Control_8 | ||
Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1. Japanese
2. Men or women 3. Adults 4. Healthy subjects 5. Subjects whose defecation frequency is three to five times per week |
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Key exclusion criteria | 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, lactation, 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 |
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Target sample size | 30 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Medical Corporation Seishinkai, Takara Clinic | ||||||
Division name | Director | ||||||
Zip code | 141-0022 | ||||||
Address | 9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan | ||||||
TEL | 03-5793-3623 | ||||||
t-takara@takara-clinic.com |
Public contact | |||||||
Name of contact person |
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Organization | ORTHOMEDICO Inc. | ||||||
Division name | R&D Department | ||||||
Zip code | 112-0002 | ||||||
Address | 2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan. | ||||||
TEL | 03-3818-0610 | ||||||
Homepage URL | |||||||
nao@orthomedico.jp |
Sponsor | |
Institute | ORTHOMEDICO Inc. |
Institute | |
Department |
Funding Source | |
Organization | Ikeda Food Research Co.,Ltd. |
Organization | |
Division | |
Category of Funding Organization | Profit organization |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | Medical Corporation Seishinkai, Takara Clinic
Nerima Medical Association, Minami-machi Clinic |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | the ethical committee of the Takara Clinic, Medical Corporation Seishinkai |
Address | 9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan. |
Tel | 03-5793-3623 |
IRB@takara-clinic.com |
Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions | 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) |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Number of participants that the trial has enrolled | |
Results | |
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Results Delayed | |
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Baseline Characteristics | |
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Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Open public recruiting | ||||||
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Management information | |||||||
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Last modified on |
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Link to view the page | |
URL(English) | https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055354 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |