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A study of the effect of syoseiryuto on Japanese cedar pollinosis (randomized, placebo-controlled, double-blind study using the envionmental challenge chamber)

Not Applicable
Conditions
Japnese cedar pollinosis
Registration Number
JPRN-UMIN000033286
Lead Sponsor
Department of Otorhinolaryngology in Chiba University hospital
Brief Summary

47 cases participaterd in the trial and 46 cases were analized. In comparison with a placebo group, total nasal symptom score at 6 hour and 9 hour from the leaving chamber was significantly lower in shoseiryuto group. However, the statistical significant difference between plasebo and shoseiryuto was not clear from 120 min to 180min in the environmental challenge chamber.

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
47
Inclusion Criteria

Not provided

Exclusion Criteria

1) Allergy of intervention drug 2) Patients who develop mild 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) Aldosteronism, myopathy, hypokalemia 6) Pregnant women and those at risk of pregnancy 7) Women who are planning pregnancy 8) Lactating woman 9) Patients treated with anti-allergic drugs within 2 week of screening 10) The patients who the doctor judged inappropriate for the study

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Total nasal symptoms induced in the environmental challernge chamber after intake of the intervention drug for 2 weeks.
Secondary Outcome Measures
NameTimeMethod
Association between "syo" and effect of the Shoseiryuto
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