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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035870
Receipt No. 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 2020/02/18

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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
Obsterics 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
Email 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
Email n-yoshikawa@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2019 Year 02 Month 13 Day
Date of IRB
Anticipated trial start date
2019 Year 10 Month 01 Day
Last follow-up date
2020 Year 02 Month 13 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
2020 Year 02 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040861

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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