UMIN-CTR Clinical Trial

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000012580
Receipt No. R000014716
Scientific Title Effects of Kampo medical formula for the blood circulation in the eye with healthy subjects
Date of disclosure of the study information 2013/12/16
Last modified on 2020/08/04 (Ver. 6)

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Basic information
Public title Effects of Kampo medical formula for the blood circulation in the eye with healthy subjects
Acronym Effects of Kampo medical formula for the blood circulation in the eye
Scientific Title Effects of Kampo medical formula for the blood circulation in the eye with healthy subjects
Scientific Title:Acronym Effects of Kampo medical formula for the blood circulation in the eye
Region
Japan

Condition
Condition healthy subjects
Classification by specialty
Medicine in general Cardiology Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluate the effects of Kampo medical formula in the eye
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes blood circulation in the eye evaluetad by Laser Speckle Flowgraphy
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit
Blinding Single blind -participants are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 5
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 yokukansan 5g
Interventions/Control_2 tokishakuyakusan 5g
Interventions/Control_3 keishibukuryogan 5g
Interventions/Control_4 hachimijiogan 5g
Interventions/Control_5 water
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
70 years-old >
Gender Male and Female
Key inclusion criteria Intra ocular pressure <= 22 mmHg
Without abnormality in funduscopy
Without the history of surgery to the eye
Without HT or DM
Without the history of smoking hanits
Key exclusion criteria Intra ocular pressure => 22 mmHg
Abnormality in funduscopy
With the history of surgery to the eye
With HT or DM
With the history of smoking hanits
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Shin
Middle name
Last name Takayama
Organization Tohoku University Graduate School of Medicine
Division name Comprehensive Education Center for Community Medicine
Zip code 980-8574
Address 2-1, Seiryo-machi, Aoba ward, Sendai 980-8575, Japan
TEL 022-717-8010
Email takayama@med.tohoku.ac.jp

Public contact
Name of contact person
1st name Akiko
Middle name
Last name Kuwabara
Organization Tohoku University Hospital
Division name Comprehensive Regional Medical Education Support Department, Kampo Internal Medicine
Zip code 980-8574
Address 1-1, Seiryo-machi, Aoba ward, Sendai 980-8575, Japan
TEL 022-717-7507
Homepage URL
Email akiko.kuwabara.d7@tohoku.ac.jp

Sponsor
Institute Tohoku university
Institute
Department

Funding Source
Organization JSPS
KAKEN
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Ethics Committee Tohoku University Hospital
Address 1-1, Seiryo-machi, Aoba ward, Sendai
Tel 022-728-4105
Email ec@rinri.hosp.tohoku.ac.jp

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
2013 Year 12 Month 16 Day

Related information
URL releasing protocol http://www.hindawi.com/journals/ecam/2014/586857/
Publication of results Published

Result
URL related to results and publications http://www.hindawi.com/journals/ecam/2014/586857/
Number of participants that the trial has enrolled
Results 
A crossover protocol was used to randomly administer five grams of yokukansan, tokishakuyakusan (TSS), keishibukuryogan, or hachimijiogan to 13 healthy blinded subjects (mean age: 37.3 years). The mean blur rate, a quantitative OBF index obtained with laser speckle flowgraphy, was measured at the optic nerve head before and 30 minutes after administration. Blood pressure (BP) and intraocular pressure (IOP) were also recorded. No significant changes were observed in mean BP or IOP after the administration of any of the kampo medical formulas. There was a significant increase in OBF 30 minutes after administration of TSS (100% to 103.6 %, p < 0.01). Next, TSS was administered to 19 healthy subjects (mean age: 32.0 years) and OBF was measured before and 15, 30, 45, and 60 minutes after administration. Plain water was used as a control. OBF increased significantly after TSS administration compared to control (p < 0.01) and also increased from 30 to 60 minutes after administration compared to baseline (p < 0.05).
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 Main results already published
Date of protocol fixation
2013 Year 01 Month 28 Day
Date of IRB
Anticipated trial start date
2013 Year 08 Month 01 Day
Last follow-up date
2014 Year 01 Month 05 Day
Date of closure to data entry
2014 Year 01 Month 14 Day
Date trial data considered complete
2014 Year 01 Month 28 Day
Date analysis concluded
2014 Year 02 Month 01 Day

Other
Other related information

Management information
Registered date
2013 Year 12 Month 15 Day
Last modified on
2020 Year 08 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014716