UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062056 |
|---|---|
| Receipt number | R000071000 |
| Scientific Title | A Study of the Efficacy of Chukenchuto in Gynecologic Laparoscopic Surgery |
| Date of disclosure of the study information | 2026/06/29 |
| Last modified on | 2026/06/25 16:33:49 |
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Basic information
Public title
A Study of the Efficacy of Chukenchuto in Gynecologic Laparoscopic Surgery
Acronym
A Study of the Efficacy of Chukenchuto in Gynecologic Laparoscopic Surgery
Scientific Title
A Study of the Efficacy of Chukenchuto in Gynecologic Laparoscopic Surgery
Scientific Title:Acronym
A Study of the Efficacy of Chukenchuto in Gynecologic Laparoscopic Surgery
Region
| Japan |
Condition
Condition
Postoperative Gastrointestinal Complications Following Gynecologic Laparoscopic Surgery
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate the effects of Chukenchuto, a Kampo medicine, on postoperative abdominal symptoms and patient satisfaction in patients undergoing gynecologic laparoscopic surgery. By clarifying the clinical benefits of Chukenchuto, this study aims to contribute to the establishment of more appropriate postoperative management strategies.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time required for the first postoperative bowel movement
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
12days
Interventions/Control_2
Take 5 g (a combination of 2.5 g of Daikenchuto extract granules and 2.5 g of Shokenchuto extract granules) three times daily, 30 minutes before each meal.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Aged 18 years or older
Patients who underwent one of the following surgeries
Laparoscopic surgery: Surgery for benign disease
Robot-assisted surgery: Total hysterectomy or sacrocolpopexy
Patients who provided consent to participate in this study by signing the consent form
Key exclusion criteria
Those who do not meet the following requirements
Aged 18 years or older
Patients who underwent one of the following surgeries:
Laparoscopic surgery: Surgery for benign disease
Robot-assisted surgery: Total hysterectomy or sacrocolpopexy
Patients who provided consent to participate in this study by signing the consent form
Target sample size
330
Research contact person
Name of lead principal investigator
| 1st name | Ryo |
| Middle name | |
| Last name | Sugimura |
Organization
Shizuoka City Shizuoka Hospital
Division name
Obstetrics and Gynecology
Zip code
420-8630
Address
10-93 Otemachi, Aoi-ku, Shizuoka-shi, Shizuoka 420-8630, Japan
TEL
054-253-3125
ryo.sugimura55@gmail.com
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Sugimura |
Organization
Shizuoka City Shizuoka Hospital
Division name
Obstetrics and Gynecology
Zip code
420-8630
Address
10-93 Otemachi, Aoi-ku, Shizuoka-shi, Shizuoka 420-8630, Japan
TEL
054-253-3125
Homepage URL
chiken2@shizuokahospital.jp
Sponsor or person
Institute
Shizuoka City Shizuoka Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shizuoka City Shizuoka Hospital
Address
10-93 Otemachi, Aoi-ku, Shizuoka-shi, Shizuoka 420-8630, Japan
Tel
054-253-3125
chiken2@shizuokahospital.jp
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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 06 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 06 | Month | 25 | Day |
Last modified on
| 2026 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000071000
