UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056394 |
|---|---|
| Receipt number | R000060075 |
| Scientific Title | Effects of tranexamic acid on sore throat pain associated with acute upper respiratory tract infection: a randomized, controlled trial |
| Date of disclosure of the study information | 2024/12/08 |
| Last modified on | 2026/02/04 15:14:02 |
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Basic information
Public title
Effects of tranexamic acid on sore throat pain associated with acute upper respiratory tract infection: a randomized, controlled trial
Acronym
Effects of tranexamic acid on sore throat pain associated with common cold
Scientific Title
Effects of tranexamic acid on sore throat pain associated with acute upper respiratory tract infection: a randomized, controlled trial
Scientific Title:Acronym
Effects of tranexamic acid on sore throat pain: a randomized, controlled trial
Region
| Japan |
Condition
Condition
upper respiratory tract infection
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
We investigate the efficacy of tranexamic acid on sore throat pain associated with acute URTI compared with a placebo.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The proportion of patients with sore throat score more than moderate level between 2 hours after tranexamic acid is taken.
Key secondary outcomes
Primary outcome is the difference on sore throat VAS scale between 10 minutes after tranexamic acid is taken.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients receive 1g of 50% tranexamic acid preparation of with a cup of water.
Interventions/Control_2
Patients receive 1g placebo (lactose), desolved with a cup of water.
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
| 18 | 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 internal medicine department office in the Akashi medical center hospital from November 2023 to October 2024 were registered.
Key exclusion criteria
Patients with allergy to tranexamic acid and lactose, pregnant patients or patients with possibility of pregnancy, breastfeeding patients, patients who take tranexamic acid, 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
80
Research contact person
Name of lead principal investigator
| 1st name | Naoto |
| Middle name | |
| Last name | Ishimaru |
Organization
Akashi Medical Center
Division name
Department of General Internal Medicine
Zip code
6740063
Address
743-33 Yagi, Ohkubo-cho, Akashi, Hyogo 674-0063, Japan
TEL
0789361101
maru-tkb@umin.ac.jp
Public contact
Name of contact person
| 1st name | Naoto |
| Middle name | |
| Last name | Ishimaru |
Organization
Akashi Medical Center
Division name
Department of General Internal Medicine
Zip code
6740063
Address
743-33 Yagi, Ohkubo-cho, Akashi, Hyogo 674-0063, Japan
TEL
0789361101
Homepage URL
maru-tkb@umin.ac.jp
Sponsor or person
Institute
Akashi Medical Center
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Institutional Review Board of Akashi Medical Center
Address
743-33 Yagi, Ohkubo-cho, Akashi, Hyogo 674-0063, Japan
Tel
0789361101
tani.saori@aijinkai-group.com
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
| 2024 | Year | 12 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/abs/10.1002/jgf2.70097
Number of participants that the trial has enrolled
41
Results
We analyzed the 17 participants assigned to each group (total = 34). The groups were not significantly different in the proportion of patients whose sore throat had a moderate or greater impact on their day-to-day life (TXA 41.2% vs. placebo 47.1%; p = 1.00). Similarly, they did not significantly differ in mean change of sore throat score on VAS within 30 min (TXA 17.3 vs. placebo 13.1; p = 0.49). No side effects were reported.
Results date posted
| 2026 | Year | 02 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2026 | Year | 01 | Month | 03 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 10 | Month | 28 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 18 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 06 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 12 | Month | 08 | Day |
Last modified on
| 2026 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060075
