UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007080 |
|---|---|
| Receipt number | R000008323 |
| Scientific Title | kikyo-to, a Japanese herbal medicine, for pain relief in sore throat |
| Date of disclosure of the study information | 2012/01/17 |
| Last modified on | 2014/12/01 18:07:17 |
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Basic information
Public title
kikyo-to, a Japanese herbal medicine, for pain relief in sore throat
Acronym
kikyo-to for pain relief in sore throat
Scientific Title
kikyo-to, a Japanese herbal medicine, for pain relief in sore throat
Scientific Title:Acronym
kikyo-to for pain relief in sore throat
Region
| Japan |
Condition
Condition
upper respiratory tract infection.
Classification by specialty
| Medicine in general | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study was designed to determine the efficacy of kikyo-to in the relief of acute sore throat caused by upper respiratory tract infections.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Primary outcome is the difference of sore throat VAS scale between 10 minutes after kikyo-to is taken.
Key secondary outcomes
Secondary outcomes are the proportion of patients with sore throat score more than moderate level and the difference of sore throat VAS scale between 30 minutes after kikyo-to is taken.
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
| Medicine |
Interventions/Control_1
Patients receive 2.5g herbal extract preparation of kikyo-to, a Japanese herbal medicine, desolved with a cup of hot water.
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients of upper respiratory tract infections with a complaint of sore throat, who visited a general medicine department office in the Tsukuba medical center hospital from January to March 2012 were registered.
Key exclusion criteria
Patients with allergy to kikyo-to, patients with aldosteronism, patients with myopathy, patients with known hypokalemia, pregnant patients or patients with possibility of pregnancy, breastfeeding patients, patients who take kikyo-to, patients inurgent condition, patients who were unable to participate the study because of dementia, visual impairment and unable to answer, or complete the study form.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masatsune Suzuki |
Organization
Tsukuba Medical Center Hospital
Division name
Department of General Internal Medicine
Zip code
Address
Amakubo 1-3-1,Tsukuba,Ibaraki
TEL
029-851-3511
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoto Ishimaru |
Organization
Tsukuba University Hospital, Japan
Division name
General Medicine and Primary Care
Zip code
Address
Amakubo 2-1-1, Tsukuba,Ibaraki
TEL
029-853-3189
Homepage URL
Sponsor or person
Institute
Tsukuba University Hospital, Japan
Institute
Department
Personal name
Funding Source
Organization
Tsukuba University Hospital, Japan
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
筑波メディカルセンター病院
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 01 | Month | 17 | Day |
Related information
URL releasing protocol
http://www.ncbi.nlm.nih.gov/pubmed/24356393
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/24356393
Number of participants that the trial has enrolled
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
Progress
Recruitment status
Completed
Date of protocol fixation
| 2011 | Year | 12 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 01 | Month | 17 | Day |
Last modified on
| 2014 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008323
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
