UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012580 |
|---|---|
| Receipt number | 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 14:06:19 |
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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
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
akiko.kuwabara.d7@tohoku.ac.jp
Sponsor or person
Institute
Tohoku university
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014716
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