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Comparative study between Tokisyakuyakusan and mecobalamin for the efficacy in patients with olfactory dysfunction post-respiratory infectio

Not Applicable
Conditions
olfactory dysfunction post-respiratory infection
olfactory dysfunction
Registration Number
JPRN-jRCTs041190005
Lead Sponsor
Miwa Takaki
Brief Summary

This study demonstrated that there was no difference the effects of Toki-shakuyakusa and mecobalamin on post infectious olfactory dysfunctions at 24 weeks after the start of administration.

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
82
Inclusion Criteria

1) Patients with olfactory dysfunction post-respiratory infection who have developed from at least four weeks ago and within less than one year.
2) Patients aged 20 years old or more and 65 years old or less.
3) Gender unquestioned
4) Outpatient
5) Patients with olfactory dysfunction who have odor recognition thresholds by T&T olfactometry as 2.6 and more (moderate or severe dysosmia)
6) Patients who have given voluntary written informed consent.

Exclusion Criteria

1) Patients who have rhinosinusitis which is subjected to effect on olfactory dysfunction post-respiratory infection.
2) Patients who used Tokisyakuyakusan or mecobalamin within the last two weeks (It will be eligible if they do not use those medicine for at least two weeks).
3) Patients who are pregnant, suspected to be pregnant or breastfeeding.
4) Patients who desire to bear children
5) Patients who are considered not to be eligible by the investigator.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Evaluation with T&T olfactometry after the treatment for 24 weeks
Secondary Outcome Measures
NameTimeMethod
Detection and recognition threshold between group, VAS score, Dysosmia, Safetiness
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