NOT-Nocturia study

JRCT ID: jRCTs051180071

Registered date:21/02/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: nocturia
• Date of first enrollment: 09/11/2018
• Target sample size: 40
• Study type: Interventional
• Intervention(s): crossover design. True food preceding group:Mixture 50mg of nobiletin and tangeretin will be orally administered every day, once after dinner for 6 weeks. After a washout period of 2 weeks, the placebo will be orally administered every day, once after dinner for 6 weeks.Placebo preceding group: the placebo will be orally administered every day, once after dinner for 6 weeks. After a washout period of 2 weeks, mixture 50mg of nobiletin and tangeretin will be orally administered every day, once after dinner for 6 weeks.

Outcome(s)

• Primary Outcome: The change of nocturnal functional bladder capacity
• Secondary Outcome: IPSS/PSQI score, The change on frequency of urination at night, The change of nocturnal urine volume

Key inclusion & exclusion criteria

• Age minimum: 50age
• Age maximum: Not applicable
• Gender: Both

Include criteria

1)Patients who has to wake at night more than twice for voiding
2)Patients who has a proper comprehension and compliance
3)50 years old or more patients
4)Patients with ECOG PS 0-2
5)Patients who go to a hospital regularly

Exclude criteria

1)Patients with polyuria
2)Residual urine volume is more than 200mL
3)Patients with benign prostatic hyperplasia, over active bladder and neurogenic bladder, who need the treatment other than nocturia
4)Any other patients who are regarded as unsuitable for this study by the investigator

Related Information

• Primary Sponsor: Ito Haruki
• Source(s) of Monetary Support: Okinawa Research Center