UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035870 |
|---|---|
| Receipt number | R000040861 |
| Scientific Title | Randomized Phase II study of TJ-25 and TJ-61 in Oketsu patients with lower abdominal pain |
| Date of disclosure of the study information | 2019/10/01 |
| Last modified on | 2022/08/16 12:00:10 |
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Basic information
Public title
Randomized Phase II study of TJ-25 and TJ-61 in Oketsu patients with lower abdominal pain
Acronym
Randomized Phase II study of TJ-25 and TJ-61 in Oketsu patients with lower abdominal pain
Scientific Title
Randomized Phase II study of TJ-25 and TJ-61 in Oketsu patients with lower abdominal pain
Scientific Title:Acronym
Randomized Phase II study of TJ-25 and TJ-61 in Oketsu patients with lower abdominal pain
Region
| Japan |
Condition
Condition
Oketsu with lower abdominal pain
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The purpose of this study is to evaluate therapeutic efficacy of TJ-25 or TJ-61 for Oketsu women who complain of lower abdominal pain, so that these medicines for lower abdominal pain and Oketsu symptoms.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Abdominal pain (VAS scale, dysmenorrhea score)
Oketsu seriousness (Oketsu score)
For the above, compare scores before treatment and after 28 days
Key secondary outcomes
Cold (cold score)
Stiff shoulder (VAS scale)
For the above, compare scores before treatment and after 28 days
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
No additional medicine
Interventions/Control_2
TJ-25
Interventions/Control_3
TJ-61
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1) Patients who have lower abdominal pain in chief complaint and who are recommended for medication by general examination (internal examination, ultrasonic examination)
2) Patients with ECOG-PS 0 or 1
3) Patients whose main organ function is adequately maintained
(A) White blood cell count > 3,500 / mm 3, < 12 000 / mm 3
(B) Number of neutrophils > 1,500 / mm 3
(C) Platelet count > 100,000 / mm 3
(D) Hb > 9.0 g / dL
(E) AST , ALT < 100 IU / L
(F) Creatinine < 1.2 mg / dL
Key exclusion criteria
1) Patients with allergies to traditional Chinese medicine
2) Patients with severe complications (such as heart failure, renal failure, liver failure, hypoactive nutrition) and severe mental illness
3) Patients whose oral ingestion is impossible
4) Patients already receiving prescription of traditional Chinese medicine for the current pain episode
5) In addition, patients judged unsuitable for doctors to safely carry out this study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Kajiyama |
Organization
Nagoya University School of Medicine
Division name
Department of obstetrics and gynecology
Zip code
4668550
Address
Tsuruma-cho 65, Showa-ku, Nagoya
TEL
052-744-2261
kajiyama@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Nobuhisa |
| Middle name | |
| Last name | Yoshikawa |
Organization
Nagoya University School of Medicine
Division name
Department of obstetrics and gynecology
Zip code
4668550
Address
Tsuruma-cho 65, Showa-ku, Nagoya
TEL
052-744-2261
Homepage URL
n-yoshikawa@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for medical research and development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB
Address
Tsuruma-cho 65, Showa-ku, Nagoya
Tel
052-744-2423
iga-shinsa@adm.nagoya-u.ac.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
| 2019 | Year | 10 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2019 | Year | 02 | Month | 13 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 13 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 02 | Month | 13 | Day |
Last modified on
| 2022 | Year | 08 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040861
