Unique ID issued by UMIN | UMIN000017822 |
---|---|
Receipt number | 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 | 2022/12/28 11:30:02 |
Efficacy of Sho-saiko-to-ka-kikyo-sekko, a Japanese herbal medicine, in acute pharyngitis and tonsillitis patients
Efficacy of Sho-saiko-to-ka-kikyo-sekko on acute pharyngitis and tonsillitis
Efficacy of Sho-saiko-to-ka-kikyo-sekko, a Japanese herbal medicine, in acute pharyngitis and tonsillitis patients
Efficacy of Sho-saiko-to-ka-kikyo-sekko on acute pharyngitis and tonsillitis
Japan |
acute pharyngitis, acute tonsillitis
Medicine in general | Adult |
Others
NO
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.
Efficacy
Confirmatory
Pragmatic
Not applicable
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.
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.
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
NO
Institution is not considered as adjustment factor.
NO
Numbered container method
2
Treatment
Medicine |
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.
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.
20 | years-old | <= |
75 | years-old | > |
Male and Female
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.
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
54
1st name | Toshio |
Middle name | |
Last name | Naito |
Juntendo university school of medicine
Department of General medicine
113-8421
3-2-12, Hongo, Bunkyo-ku, Tokyo 113-8421, Japan
03-3813-3111
naito@juntendo.ac.jp
1st name | Yukiko |
Middle name | |
Last name | Fukui |
Juntendo university school of medicine
Department of General medicine
113-8421
3-2-12, Hongo, Bunkyo-ku, Tokyo 113-8421, Japan
03-3813-3111
yukiko-w@juntendo.ac.jp
Department of General medicine
Juntendo university school of medicine
Department of General medicine
Juntendo university school of medicine
Other
Department of General medicine Juntendo university school of medicine
3-2-12, Hongo, Bunkyo-ku, Tokyo 113-8421, Japan
03-3813-3111
yukiko-w@juntendo.ac.jp
NO
順天堂大学医学部附属順天堂医院
2015 | Year | 06 | Month | 05 | Day |
Unpublished
No longer recruiting
2015 | Year | 05 | Month | 22 | Day |
2015 | Year | 05 | Month | 22 | Day |
2015 | Year | 06 | Month | 01 | Day |
2021 | Year | 08 | Month | 31 | Day |
2015 | Year | 06 | Month | 05 | Day |
2022 | Year | 12 | Month | 28 | Day |
Value
https://center6.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 |