Unique ID issued by UMIN | UMIN000022472 |
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Receipt number | R000025895 |
Scientific Title | Exploratory study of the effect of proplis on Japanese cedar pollinosis (randomized, placebo-controlled, double-blind study using the envionmental challenge chamber) |
Date of disclosure of the study information | 2016/05/26 |
Last modified on | 2019/02/19 05:54:35 |
Exploratory study of the effect of proplis on Japanese cedar pollinosis (randomized, placebo-controlled, double-blind study using the envionmental challenge chamber)
Exploratory study of the effect of proplis on Japanese cedar pollinosis
Exploratory study of the effect of proplis on Japanese cedar pollinosis (randomized, placebo-controlled, double-blind study using the envionmental challenge chamber)
Exploratory study of the effect of proplis on Japanese cedar pollinosis
Japan |
Japanese cedar pollinosis
Oto-rhino-laryngology |
Others
NO
To crarify whether 8 weeks intake of propolis suppress the nasal symptoms induced in the environmental challernge chamber.
Efficacy
Total nasal symptoms induced in the environmental challernge chamber after intake of the intervention food for 8 weeks.
Interventional
Cross-over
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Treatment
Food |
Intake of propolis for 8 weeks
Intake of placebo food for 8 week
20 | years-old | <= |
60 | years-old | > |
Male and Female
1)Patients who have medical history of cedar pollinosis for more than 2 years.
2)Patients who do not have nasal symtoms induced by any allergen and requier any drug treatment out of Japanese cedar pollen scattering season.
3)Positive specific IgE to cedar pollen allergen(>=class2)
4)Patients who develop mild or moderate symptoms by a pollen exposure for 3 hours.
1) Food allergy including intervention food
2) Patients who develop severe symptoms by a pollen exposure for 3 hours.
3) Patients with nasal disease that affects the evaluation of the study
4) Severe respiratory disease, heart disease, liver disease, kidney disease, diabetes, autoimmune disease
5) Pregnant women and those at risk of pregnancy
6) Women who are planning pregnancy
7) Lactating woman
8) Patients treated with anti-allergic drugs within 2 week of screening
7) The patients who the doctor judged inappropriate for the study
50
1st name | |
Middle name | |
Last name | Yoshitaka Okamoto |
Chiba University Graduate School
Department of Otorhinolaryngology
1-8-1 Inohana,Chuo-ku Chiba 260-8677
043-222-7171
yokamoto@faculty.chiba-u.jp
1st name | |
Middle name | |
Last name | Syuji Yonekura |
Chiba University Graduate School
Department of Otorhinolaryngology
1-8-1 Inohana,Chuo-ku Chiba 260-8677
043-222-7171
syonekura@faculty.chiba-u.jp
Department of Otorhinolaryngology in Ciba University Graduate School
Yamada Bee Farm
Profit organization
NO
2016 | Year | 05 | Month | 26 | Day |
Unpublished
48 cases participated in the trial. The total nasal symptom score , the primaly end-point, was 3.54 and 3.69 in propolis and placebo groups, reaprectively. A significant difference was not recognized.
Completed
2016 | Year | 05 | Month | 16 | Day |
2016 | Year | 08 | Month | 01 | Day |
2017 | Year | 03 | Month | 31 | Day |
2017 | Year | 06 | Month | 30 | Day |
2017 | Year | 07 | Month | 26 | Day |
2017 | Year | 08 | Month | 25 | Day |
2016 | Year | 05 | Month | 26 | Day |
2019 | Year | 02 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025895
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