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Investigation on efficacy and safety of TJ-50 for the patients with postoperative chronic sinusitis

Investigation on efficacy and safety of TJ-50 for the patients with postoperative chronic sinusitis - Chronic Sinusitis and TJ-50

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000031689
Enrollment
40
Registered
2018-03-12
Start date
2018-04-02
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Sinusitis

Interventions

The group received the standard treatment with TJ-50 for 3 months after surgery. The group received the standard treatment without TJ-50 for 3 months after surgery.

Sponsors

Yokohama city university medical center Otolaryngolgy
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) The patient is diagnosed with chronic sinusitis 2) The patient is planned treatment by ESS( Endoscopic Sinus Surgery) 3) The patient can be treated with long-term, low-dose macrolide. 4) 20 to 80 years old 5) Written informed consent of this study is obtained from the patient

Exclusion criteria

Exclusion criteria: 1) The patients scheduled to undergo surgical procedures other than ESS as a treatment for chronic sinusitis 2) The patients suspected of typical eosinophilic sinusitis 3) The patients complicated of aspirin asthma 4) The patients complicated with bronchial asthma 5) THe patients complicated of NSAIDs allergy 6) Pregnant women, lactating women, and patients who have the possibility or intention of pregnancy 7) The patients who are merging psychosis or psychiatric symptoms and are considered difficult to participate in the study 8) The patients judged unsuitable by researchers

Design outcomes

Primary

MeasureTime frame
A score of the QOL by the patient using SNOT-22 at 3 months after the ESS

Secondary

MeasureTime frame
1) Nasal mucosal findings (Baba's score) 2) Colony Forming Unit (CFU) in the nasal cavity 3) Olfactory survey (VAS) 4) Laboratory test values (WBC, leukocyte fraction (neutrophils, eosinophils, basophils, lymphocytes, monocytes))

Countries

Japan

Contacts

Public ContactHiromitsu Hatakeyama

Otolaryngolgy Yokohama city university medical center

htkym@yokohama-cu.ac.jp045-261-5656

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026