UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044157
Receipt No. R000050424
Scientific Title The slimming effect by regularly hot yoga : single blinded study
Date of disclosure of the study information 2021/05/11
Last modified on 2021/05/10

* 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 slimming effect by regularly hot yoga
Acronym Hot yoga Study
Scientific Title The slimming effect by regularly hot yoga : single blinded study
Scientific Title:Acronym The slimming effect by regularly hot yoga
Region
Japan

Condition
Condition Healthy adult female
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Conduct a hot yoga program twice a week and evaluate the slimming effect after 12 weeks
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Weight, BMI, circumference (bust, waist, hips, upper arm, thighs, calves)
Key secondary outcomes skin condition, blood test

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Continue Hot Yoga (A type) for 12 weeks
Interventions/Control_2 Continue Hot Yoga (B type) for 12 weeks
Interventions/Control_3 Life as usual for a certain period of time
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
59 years-old >=
Gender Female
Key inclusion criteria 1. BMI 23 and above
2. Subjects who are aware of lack of exercise
Key exclusion criteria 1. Subjects who have significant changes in their physical condition before and after menopause
2. Subjects who are pregnant / lactating,Subjects who are planning to become pregnant
3. Subjects who are currently going to the hospital or have a doctor's prescription
4. Subjects who have regular experience of hot yoga (excluding experience only)
5. Subjects who are taking supplements / medicines that affect the test (slimming, fat loss, etc.) / Subjects who are planning to start taking
6. Smoking and alcoholics
7. Subjects who may be on a business trip or transfer during the exam period
8. Subjects with inflammation or skin disorders on the face
9. Subjects with allergies such as atopy
10. Subjects who have participated in other clinical trials within the last month, those who plan to participate during the trial period
11. Subjects who are currently exercising 3 times a week for 1 hour or more
Target sample size 54

Research contact person
Name of lead principal investigator
1st name Masatomo
Middle name
Last name Najima
Organization Japan Clinical Trial Association
Division name N.A.
Zip code 1600022
Address 5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
TEL 0364574666
Email info@yakujihou.org

Public contact
Name of contact person
1st name Takeshi
Middle name
Last name Kaneko
Organization Japan Clinical Trial Association
Division name N.A.
Zip code 1600022
Address 5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
TEL 0364574666
Homepage URL
Email info@yakujihou.org

Sponsor
Institute Japan Clinical Trial Association
Institute
Department

Funding Source
Organization LAVA International, Inc.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Institutional Review Board of Pharmaceutical Law Wisdoms
Address 5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
Tel 0364574911
Email master@yakujihou.net

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
2021 Year 05 Month 11 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
2021 Year 03 Month 26 Day
Date of IRB
2021 Year 04 Month 15 Day
Anticipated trial start date
2021 Year 05 Month 11 Day
Last follow-up date
2021 Year 08 Month 06 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 05 Month 10 Day
Last modified on
2021 Year 05 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050424

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.