UMIN-CTR Clinical Trial

Basic information
Public title	A verification study of actual feeling of the effects of royal jelly
Acronym	A verification study of actual feeling of the effects of royal jelly
Scientific Title	A verification study of actual feeling of the effects of royal jelly: an open-label trial
Scientific Title:Acronym	A verification study of actual feeling of the effects of royal jelly
Region	Japan

Condition
Condition	Healthy Japanese subjects
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify the effects of raw royal jelly on actual feeling of fatigue
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Visual Analogue Scale (VAS) of fatigue * Conform to the methods of Japanese Society of Fatigue Science * Assess the measured value at screening (before consumption) and at 12 weeks after consumption or calculate the amount of change.
Key secondary outcomes	1. Urinary 8-OHdG 2. Simplified Menopausal Index (SMI) 3. OSA sleep inventory MA version 4. Subjective symptoms (The Likert scale method) 5. Blood estradiol level 6. Blood free testosterone level 7. Blood lymphocytes / neutrophils ratio *1-3, 5-7 Assess the measured value at screening (before consumption) and at 12 weeks after consumption or calculate the amount of change. *4 Assess the measured value at screening (before consumption) and at 12 weeks after consumption.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Duration: 12 weeks Test food: Raw royal jelly capsule Administration: Take 4 capsules with water once a day at any time of the day * Daily dose must be taken within the day.
Interventions/Control_2
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	40 years-old <=
Age-upper limit	69 years-old >=
Gender	Female
Key inclusion criteria	1. Healthy Japanese adult 2. Subjects who feel fatigue in daily and difficult to recover 3. Subjects who are judged as eligible to participate in the study by the physician 4. Within the subjects who met 1st to 3rd inclusion criteria, select subjects with relatively high score in VAS of fatigue.
Key exclusion criteria	1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who use or take "Foods for Specified Health Uses", "Foods with Function Claims", or other functional food/beverage in daily 5. Subjects who are diagnosed with menopausal syndrome 6. Subjects who are currently taking medications (including herbal medicines) and supplements 7. Subjects who have experienced allergic reactions to bee stings 8. Subjects who have the medical history or under the treatment of asthma 9. Subjects who have the medical history or under the treatment of atopy 10. Subjects who are hypotension 11. Subjects who are allergic to medicines and/or the test food related products 12. Subjects who are pregnant, lactation, or planning to become pregnant 13. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to enroll in anther clinical trial during trial period 14. Subjects who are ineligibility to participate in the study based on the evaluation of the principal physician
Target sample size	45

Research contact person
Name of lead principal investigator	1st name Kazuo Middle name Last name YAMAMOTO
Organization	ORTHOMEDICO Inc.
Division name	CEO
Zip code	112-0002
Address	2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL	03-3818-0610
Email	kazu@orthomedico.jp

Public contact
Name of contact person	1st name Naoko Middle name Last name SUZUKI
Organization	ORTHOMEDICO Inc.
Division name	R&D Department
Zip code	112-0002
Address	2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL	03-3818-0610
Homepage URL
Email	nao@orthomedico.jp

Sponsor
Institute	ORTHOMEDICO Inc.
Institute
Department

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

Other related organizations
Co-sponsor	Medical Corporation Seishinkai, Takara Clinic
Name of secondary funder(s)

IRB Contact (For public release)
Organization	the ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address	9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
Tel	03-5793-3623
Email	info@takara-clinic.com

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	医療法人社団盛心会 タカラクリニック (東京都) Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)

Other administrative information
Date of disclosure of the study information	2019 Year 05 Month 07 Day

Related information
URL releasing protocol	Unpublished
Publication of results	Published

Result
URL related to results and publications	http://www.pieronline.jp/content/article/0386-3603/49010/127
Number of participants that the trial has enrolled	49
Results	Akiyama S, Hoshino T, Takara T, Mitsuo T. Reduction of fatigue with the intake of fresh royal jelly-an open-label, before-after trial-. Pharmacol Ther. 2021; 49(1): 127-141.
Results date posted	2021 Year 05 Month 28 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2021 Year 01 Month 28 Day
Baseline Characteristics	Refer to the paper
Participant flow	Refer to the paper
Adverse events	Refer to the paper
Outcome measures	Refer to the paper
Plan to share IPD	Undecided
IPD sharing Plan description	To require consultation among related companies

Progress
Recruitment status	Completed
Date of protocol fixation	2019 Year 04 Month 16 Day
Date of IRB	2019 Year 04 Month 16 Day
Anticipated trial start date	2019 Year 05 Month 07 Day
Last follow-up date	2019 Year 10 Month 19 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 05 Month 07 Day
Last modified on	2021 Year 05 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041777