Verification of safety and efficacy of saw palmetto fruit extract on urination problems in women

JRCT ID: jRCTs041200018

Registered date:15/06/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Overactive bladder
• Date of first enrollment: 16/06/2020
• Target sample size: 76
• Study type: Interventional
• Intervention(s): To evaluate the effect of saw palmetto fruit extract on dysuria in women with urination problems.

Outcome(s)

• Primary Outcome: Core Lower Urinary Tract Symptom Score (CLSS)
• Secondary Outcome: Overactive Bladder Symptom Score, Patient Global Impression; PGI, MOS 36-Item Short-Form Health Survey.

Key inclusion & exclusion criteria

• Age minimum: >= 50age old
• Age maximum: Not applicable
• Gender: Female

Include criteria

1) A woman aged 50 years or older who has had any of urinary frequency, nocturia or urinary urgency for more than 2 months, and is somewhat in trouble
2)The doctor has recognized that medical treatment is unnecessary

Exclude criteria

1) The subjects who are treating dysuria.
2) The subjects within 2 months from the end of treatment for dysuria.
3) The subjects who do not want to urinate.
4) The subjects who have difficulty urinating.
5) The subjects with lifestyle-related diseases

Related Information

• Primary Sponsor: Kageyama Shinji
• Source(s) of Monetary Support: Yawata Corporation