The efficacy of Choreito on female lower urinary tract symptoms with bladder pain

JRCT ID: jRCTs071190017

Registered date:01/08/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Lower urinary tract symptom
• Date of first enrollment: 22/11/2019
• Target sample size: 50
• Study type: Interventional
• Intervention(s): Choreito treatment

Outcome(s)

• Primary Outcome: Core Lower Urinary Tract Symptom Score(CLSS) Q9 (Bladder pain)

Secondary Outcome

CLSS
IPSS
IPSS-QOL
Severity criteria for interstitial cystitis
Uroflowmetry
Residual urine
Record of urination
Overall Treatment Efficacy
Blood parameter (IFNg, High sensitive CRP)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 89age old
• Gender: Female

Include criteria

Patient aged 20 to 90
Female patient with CLSS questionnaire Q9 (Bladder pain) 2 or higher
Total IPSS score 8 or higher

Exclude criteria

Patient with serious cardiovascular, liver disease and renal dysfunction.
Liver disease:Patients whose AST, ALT or both are more than three times the facility reference upper limit.
Renal dysfunction:Creatinine are more than 2 times the facility reference upper limit.
Woman who is pregnant, nursing, wishes to be come pregnant the study period, or can not follow instruction of physician regarding contraception.
Patients who carried the radiation therapy to the pelvis.
Patients with activity of urinary tract infection.
Patients who have history of Kampo allergies.
Other patients who are assessed to be inappropriate for study participation by the investigator.

Related Information

• Primary Sponsor: Takei Mineo
• Source(s) of Monetary Support: Tsumura &amp; Co