UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017822 |
|---|---|
| Receipt number | R000020602 |
| Scientific Title | Effect of Sho-saiko-to-ka-kikyo-sekko, a Kampo Medicine, on Patients with Acute Pharyngitis and Tonsillitis: A Randomized Controlled Study |
| Date of disclosure of the study information | 2015/06/05 |
| Last modified on | 2024/10/06 20:22:45 |
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Basic information
Public title
Effect of Sho-saiko-to-ka-kikyo-sekko, a Kampo Medicine, on Patients with Acute Pharyngitis and Tonsillitis
Acronym
Effect of Sho-saiko-to-ka-kikyo-sekko, a Kampo Medicine, on Patients with Acute Pharyngitis and Tonsillitis
Scientific Title
Effect of Sho-saiko-to-ka-kikyo-sekko, a Kampo Medicine, on Patients with Acute Pharyngitis and Tonsillitis: A Randomized Controlled Study
Scientific Title:Acronym
Effect of Sho-saiko-to-ka-kikyo-sekko on acute pharyngitis and tonsillitis
Region
| Japan |
Condition
Condition
acute pharyngitis, acute tonsillitis
Classification by specialty
| Medicine in general | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study was designed to compare the effect of Sho-saiko-to-ka-kikyo-sekko for the symptom palliation of acute pharyngitis and tonsillitis with the conventional treatment group.
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 evaluation of sore throat with four phases for five days after taking Sho-saiko-to-ka-kikyo-sekko, and to compare with the conventional treatment group.
Key secondary outcomes
Secondary outcomes are the evaluation of fever, headache, fatigue and appetite loss and dizziness with four phases for five days after taking Sho-saiko-to-ka-kikyo-sekko, and to compare with the conventional treatment group.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients take one pack (2.5g/p) of Sho-saiko-to-ka-kikyo-sekko, Kampo medicine (TJ-109), three times a day, after gurgling by dissolving in a cup of warm water.
Interventions/Control_2
Patients take one pack (1.0g/p) of PL granule (Generic ingredients: salicylamide, promethazine, methylene, disalicylate, caffeine, paracetamol) three times a day, and gargle with Azunol Gargle liquid 4% three times a day.
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
From June 2015 to October 2020, patients of acute pharyngitis and tonsillitis who visited a department of general medicine Juntendo university school of medicine and accepted to participate in this study were registered.
Key exclusion criteria
1) Patients of peritonsillar abscess
2) Patients with positive for rapid antigen streptococcus test
3) Patients who meet four Centor criteria
4) Flu patients
5) Pregnant patients and Breast-feeding patients
Target sample size
54
Research contact person
Name of lead principal investigator
| 1st name | Toshio |
| Middle name | |
| Last name | Naito |
Organization
Juntendo university school of medicine
Division name
Department of General medicine
Zip code
113-8421
Address
3-2-12, Hongo, Bunkyo-ku, Tokyo 113-8421, Japan
TEL
03-3813-3111
naito@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Yukiko |
| Middle name | |
| Last name | Fukui |
Organization
Juntendo university school of medicine
Division name
Department of General medicine
Zip code
113-8421
Address
3-2-12, Hongo, Bunkyo-ku, Tokyo 113-8421, Japan
TEL
03-3813-3111
Homepage URL
yukiko-w@juntendo.ac.jp
Sponsor or person
Institute
Department of General medicine
Juntendo university school of medicine
Institute
Department
Personal name
Funding Source
Organization
Department of General medicine
Juntendo university school of medicine
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
Department of General medicine Juntendo university school of medicine
Address
3-2-12, Hongo, Bunkyo-ku, Tokyo 113-8421, Japan
Tel
03-3813-3111
yukiko-w@juntendo.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
順天堂大学医学部附属順天堂医院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 06 | Month | 05 | Day |
Related information
URL releasing protocol
Unpublished (paper submitted)
Publication of results
Unpublished
Result
URL related to results and publications
Unpublished (paper submitted)
Number of participants that the trial has enrolled
31
Results
31 patients (men : women 9:22, age mean 34.16) were randomized into each groups. 15 patients were allocated to the sho-saiko-to-ka-kikyo-sekko (TJ-109) group,16 patients to the general cold preparation group. There were no statistically significant differences between the two groups in terms of age or sex. Differences with a p value <0.05 were defined as statistically significant. There were no clear statistically significant differences in all symptoms.
Results date posted
| 2024 | Year | 09 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients aged 20-75 years who visited the Department of General Medicine at Juntendo University Hospital between June 2015 and October 2020 and were diagnosed with acute pharyngitis or tonsillitis, and who provided informed consent to participate in the clinical study.
Participant flow
Participants were randomly assigned to either the sho-saiko-to-ka-kikyo-sekko (TJ-109) group or the general cold preparation group: PL combination granules/Azunol gargle liquid 4% using the envelope method.
Adverse events
none
Outcome measures
Primary outcome measures included sore throat, fever, headache, malaise, appetite loss, and dizziness. Patients recorded the intensity of each symptom on a 4-point scale on evaluation postcards from days 1 to 5 of treatment
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2015 | Year | 05 | Month | 22 | Day |
Date of IRB
| 2015 | Year | 05 | Month | 22 | Day |
Anticipated trial start date
| 2015 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 04 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 05 | Day |
Last modified on
| 2024 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020602
