UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026718 |
|---|---|
| Receipt number | R000030205 |
| Scientific Title | The study of improvement effect of leg swelling by ingestion of long pepper extract |
| Date of disclosure of the study information | 2017/03/27 |
| Last modified on | 2020/01/23 09:11:55 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The study of improvement effect of leg swelling by ingestion of long pepper extract
Acronym
The study of improvement effect of leg swelling by ingestion of long pepper extract
Scientific Title
The study of improvement effect of leg swelling by ingestion of long pepper extract
Scientific Title:Acronym
The study of improvement effect of leg swelling by ingestion of long pepper extract
Region
| Japan |
Condition
Condition
Leg swelling
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to examine the improvement effect of leg swelling by ingestion of long pepper extract.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Body composition
2. Lower limbs volume
3. Circumference of lower limbs
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food | Other |
Interventions/Control_1
long pepper extract
Interventions/Control_2
placebo
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1) Person who feels swelling of lower limbs
2) 20 years or older
3) Performance status score is 0
4) No disease with treatment
5) Person from whom written consent has been obtained to participate in the study
6) person by whom going to hospital is possible, ingestible tablet at home
Key exclusion criteria
1) Person who has an allergy in long pepper
2) Person having unstable angina
3) Person having serious liver disease
4) Person with the possibility of during the pregnancy or the pregnancy or nursing mothers
5) Person who participated in other clinical study within 3 months
6) Person who judged that a study responsibility doctor was unsuitable
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Sumiyo |
| Middle name | |
| Last name | Akazawa |
Organization
Kanazawa medical university
Division name
General Internal Medicine
Zip code
9200293
Address
1-1 Daigaku, Uchinada, Kahoku, Ishikawa
TEL
076-286-2211
sumiyok@kanazawa-med.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Fujimoto |
Organization
Kanazawa Medical University
Division name
General Internal Medicine
Zip code
920-0293
Address
1-1 Daigaku, Uchinada, Kahoku, Ishikawa
TEL
076-286-2211
Homepage URL
tachi-y@kanazawa-med.ac.jp
Sponsor or person
Institute
Kanazawa Medical University
Institute
Department
Personal name
Funding Source
Organization
Maruzen pharmaceuticals Co., Ltd.
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
The ethical committees of the Kanazawa Medical University
Address
1-1 Daigaku, Uchinada, Kahoku, Ishikawa
Tel
076-218-8347
tiken@kanazawa-med.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
| 2017 | Year | 03 | Month | 27 | 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
Completed
Date of protocol fixation
| 2017 | Year | 02 | Month | 20 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 24 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 10 | Month | 03 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 27 | Day |
Last modified on
| 2020 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030205
