UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044157
Receipt number 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 2021/11/08 10:52:09

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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 or person

Institute

Japan Clinical Trial Association

Institute

Department

Personal name



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

No longer recruiting

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 11 Month 08 Day



Link to view the page

Value
https://center6.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