UMIN-CTR Clinical Trial

Public title

A verification study of the alleviation effects on symptoms after recovery from COVID-19 by using AHCC (R) with activity of enhancing human immune function including anti-virus immunity

Acronym

A verification study of the alleviation effects on symptoms after recovery from COVID-19 by using AHCC (R) with activity of enhancing human immune function including anti-virus immunity

Scientific Title

A verification study of the alleviation effects on symptoms after recovery from COVID-19 by using AHCC (R) with activity of enhancing human immune function including anti-virus immunity: a randomized, placebo-controlled, double-blind, parallel-group comparison study

Scientific Title:Acronym

A verification study of the alleviation effects on symptoms after recovery from COVID-19 by using AHCC (R) with activity of enhancing human immune function including anti-virus immunity

Region

Japan

Condition

Healthy Japanese subjects

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To verify the alleviation effects of consumption of the test food on symptoms after recovery from COVID-19 in healthy Japanese subjects

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

1. The proportion of subjects whose "Degree of Symptoms (score)" decrease by one point or more in one or more of the corresponding "Major Symptoms" as listed in the consultation checklist for patients with post-COVID-19 symptoms

Key secondary outcomes

1. The subjective symptoms questionnaires, saliva test

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Institution is not considered as adjustment factor.

Blocking

Concealment

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Duration: Four weeks
Test food: Capsule containing AHCC
Administration: Take three capsules with water after each meal. In total nine capsules a day, taken three times daily.

*If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day.

Interventions/Control_2

Duration: Four weeks
Test food: Capsule not containing AHCC
Administration: Take three capsules with water after each meal. In total nine capsules a day, taken three times daily.

*If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Japanese

2. Men or women

3. Adults

4. Healthy subjects

5. Subjects who have complaints related to post-COVID-19 central symptoms after completion of cure (e.g., breath difficulty, cough, palpitations, lassitude, malaise, headache, fluffy dizziness, insomnia, depression, decline in thought, hair loss, other skin symptoms, vertigo, loss of smell, or loss of taste (discomfort in the mouth and throat) {whose "Degree of Symptoms (score)" are one point or more in all of "Major Symptoms" as listed in the consultation checklist for patients with post-COVID-19 symptoms})

6. Subjects whose "Degree of Symptoms (score)" are two points or more in one or more of the corresponding "Major Symptoms" as listed in the consultation checklist for patients with post-COVID-19 symptoms

7. Subjects whose "Degree of Symptoms (score)" are three points or less in all of "Major Symptoms" as listed in the consultation checklist for patients with post-COVID-19 symptoms

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. Subjects currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases

4. Subjects who suffered from diseases (e.g., lifestyle disease, cardiac diseases, cancer, or respiratory diseases) except for post-COVID-19 symptoms after recovery from COVID-19

5. Subjects who have been diagnosed with post-COVID-19 symptoms

6. Subjects who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily

7. Subjects who are currently taking medications (including herbal medicines) and supplements

8. Subjects who are allergic to medicines and/or the test food related products

9. Subjects who are pregnant, lactating, or planning to become pregnant during this trial

10. Subjects who suffer from COVID-19

11. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial

12. Subjects who are judged as ineligible to participate in this study by the physician

Target sample size

40

Name of lead principal investigator

1st name	Tsuyoshi
Middle name
Last name	Takara

Organization

Medical Corporation Seishinkai, Takara Clinic

Division name

Director

Zip code

141-0022

Address

9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan

TEL

03-5793-3623

Email

t-takara@takara-clinic.com

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

Institute

ORTHOMEDICO Inc.

Institute

Department

Personal name

Organization

Amino Up Co.,Ltd

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Medical Corporation Seishinkai, Takara Clinic

Nerima Medical Association, Minami-machi Clinic

Name of secondary funder(s)

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

IRB@takara-clinic.com

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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)

南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)

Date of disclosure of the study information

2023

Year

03

Month

31

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

44

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

Recruitment status

Completed

Date of protocol fixation

2022

Year

11

Month

24

Day

Date of IRB

2022

Year

11

Month

24

Day

Anticipated trial start date

2022

Year

12

Month

13

Day

Last follow-up date

2023

Year

01

Month

28

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2022

Year

12

Month

13

Day

Last modified on

2024

Year

04

Month

15

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056674