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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000017822
Receipt No. R000020602
Scientific Title Efficacy of Sho-saiko-to-ka-kikyo-sekko, a Japanese herbal medicine, in acute pharyngitis and tonsillitis patients
Date of disclosure of the study information 2015/06/05
Last modified on 2018/01/22

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Basic information
Public title Efficacy of Sho-saiko-to-ka-kikyo-sekko, a Japanese herbal medicine, in acute pharyngitis and tonsillitis patients
Acronym Efficacy of Sho-saiko-to-ka-kikyo-sekko on acute pharyngitis and tonsillitis
Scientific Title Efficacy of Sho-saiko-to-ka-kikyo-sekko, a Japanese herbal medicine, in acute pharyngitis and tonsillitis patients
Scientific Title:Acronym Efficacy 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 efficacy 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 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, a Japanese herbal 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 July 2016, 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
Middle name
Last name Toshio Naito
Organization Juntendo university school of medicine
Division name Department of General medicine
Zip code
Address 3-2-12, Hongo, Bunkyo-ku, Tokyo 113-8421, Japan
TEL 03-3813-3111
Email naito@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yukiko Fukui
Organization Juntendo university school of medicine
Division name Department of General medicine
Zip code
Address 3-2-12, Hongo, Bunkyo-ku, Tokyo 113-8421, Japan
TEL 03-3813-3111
Homepage URL
Email yukiko-w@juntendo.ac.jp

Sponsor
Institute Department of General medicine
Juntendo university school of medicine
Institute
Department

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
Address
Tel
Email

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
Publication of results Unpublished

Result
URL related to results and publications
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 Open public recruiting
Date of protocol fixation
2015 Year 05 Month 22 Day
Date of IRB
Anticipated trial start date
2015 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 06 Month 05 Day
Last modified on
2018 Year 01 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020602

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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