Chronic Sinusitis and TJ-50

JRCT ID: jRCTs031180048

Registered date:29/11/2018

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Chronic Sinusitis
• Date of first enrollment: 28/09/2018
• Target sample size: 40
• Study type: Interventional
• Intervention(s): We aim to investigate on efficacy and safety of TJ-50 for the patient who diagnosed with chronic sinusitis and received endoscopic sinus surgery. This study was an open-label randomized trial between the groups who treated with TJ-50 or not after ESS.

Outcome(s)

• Primary Outcome: A score of the QOL by the patient using SNOT-22 at 3 months after the ESS
• Secondary Outcome: 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))

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Both
• Include 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) Both gender6)Written informed consent of this study is obtained from the patient
• Exclude 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

Related Information

• Primary Sponsor: Hatakeyama Hiromitsu
• Secondary Sponsor: KONDA AKIHITO,TSUMURA & CO.
• Secondary ID(s): 000031689