UMIN-CTR Clinical Trial

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
Email	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
Email	tachi-y@kanazawa-med.ac.jp

Sponsor
Institute	Kanazawa Medical University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030205