Tokyo, Aug. 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058774) titled 'Clinical study on the effect of Goshajinkigan for nocturia' on Aug. 15.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Urological Kampo Research Society
Condition:
Condition - Nocturia more than twice a night
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The subjects are patients aged 65 years or older with nocturia who are resistant to alpha-blockers, anticholinergics, and beta 3 agonists and wake up more than twice a night. Goshajinkigan will be administered for 12 weeks to patients with Jin-kyo, and its clinical effects will be examined.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Goshajinkigan (Tsumura Co., Ltd.). 2.5g twice a day, before breakfast and dinner (can be taken after meals if stomach discomfort occurs). The
period of administration is 12 weeks or more if possible. The patient is responsible for the cost of the medication.
Eligibility:
Age-lower limit - 65
years-old
= 300 pg/ml).
7) Patients with no desire to urinate or postvoid residual urine volume of 100 ml or more.
8) Other cases in which the attending physician judges enrollment in this study to be inappropriate.
Target Size - 100
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 06 Month 13 Day
Date of IRB - 2025 Year 07 Month 09 Day
Anticipated trial start date - 2025 Year 09 Month 01 Day
Last follow-up date - 2027 Year 08 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067203
Disclaimer: Curated by HT Syndication.
