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

JRCT ID: jRCTs041190005

Registered date:05/04/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: olfactory dysfunction post-respiratory infection
• Date of first enrollment: 16/05/2016
• Target sample size: 100
• Study type: Interventional

Intervention(s)

Tokisyakuyakusan 7.5g/day
3 times a day, before meals
24 weeks
Mecobalamin 1500µg/day
3 times a day, after meals
24 weeks

Outcome(s)

• Primary Outcome: Evaluation with T&T olfactometry after the treatment for 24 weeks
• Secondary Outcome: Detection and recognition threshold between group, VAS score, Dysosmia, Safetiness

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 65age old
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Miwa Takaki
• Source(s) of Monetary Support: Kanazawa Medical University Otorhinolaryngology
• Secondary ID(s): UMIN000021006