臨床研究等提出・公開システム

Japanese

Date of registration	Jan. 13, 2021
Last modified on	Dec. 25, 2023
Trial ID	jRCTs031200291

Scientific Title	A clinical study on the efficacy and safety of silkworm Cordyceps for cognitive function in patients with dementia
Public Title	Exploratory clinical study of silkworm cordyceps for targeting dementia patients

Contact for Scientific Queries	Name	Hiroyuki Osawa
	Affiliation	Osawa Clinic
	Address	2-8-3 Chabatake, Morioka City, Iwate Prefecture
	Telephone	+81-19-652-0038
	E-mail	hiroyukiosawa@me.com
Contact for Public Queries	Name	Daisuke Saito
	Affiliation	DKS Co. Ltd.
	Address	5 Ogawara-cho, Kisshoin, Minami-ku, Kyoto
	Telephone	+81-75-326-7572
	E-mail	d.saito@dks-web.co.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Jan. 13, 2021
Actual date of first enrollment		Dec. 01, 2021
Target sample size		40
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	Dementia over the preceding 6 months as the following criteria 1. Persons with an MMSE result of 21 or less 2. Those who are not in the habit of taking foods containing Cordyceps 3. Those who do not regularly use supplements and health foods 4. Those who have no history of treatment for malignant tumor, heart failure, myocardial infarction 5. Those who are not allergic to foods and medicines containing Cordyceps 6. Those who fully understand the content of clinical trials and have written consent
	Exclusion Criteria	1. Pregnant or breast-feeding woman or person who is willing to become pregnant during the test period 2. Those who are participating in other clinical trials and those who have participated in other clinical trials within 3 months 3. Those who cannot follow the instructions of the physicians and medical staff 4. A person who has been judged by a physicians to have any problems
	Age Minimum	40age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Dementia
Intervention(s)		Silkworm Cordyceps
Health Condition(s) Keyword		Dementia
Intervention(s) Keyword		Dementia, Silkworm Cordyceps
Health Condition(s) Code		F00, F01, F02, F03
Primary Outcome(s)		Cognitive function evaluation by eye tracking
Secondary Outcome(s)		None

Source of Monetary Support / Secondary Sponsor	DKS Co. Ltd.
Secondary Sponsor	Applicable

Name of Certified Review Board	Certified Review Board, Hattori Clinic
Address	Bessho, Hachioji-shi, Tokyo, Tokyo
Telephone	+81-3-3470-3360
E-Mail	reception-office@hattori-crb.com
Approval Status	Approval
Date of approval	July. 15, 2020

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
7	Dec. 25, 2023	(this page)	Changes
6	Dec. 07, 2023	Detail	Changes
5	Dec. 14, 2022	Detail	Changes
4	Sept. 15, 2022	Detail	Changes
3	Feb. 09, 2022	Detail	Changes
2	Dec. 10, 2021	Detail	Changes
1	Jan. 13, 2021	Detail

List of change history