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A Clinical Observation Study of a Chinese Patent Medicine Combined With Tamsulosin in Improving Sleep and Nocturia Symptoms After Enucleation of the Prostate

RecruitingPhase 4Ages 50 Years - anyMaleThe Fourth Affiliated Hospital of Zhejiang Univer…
NCT07357324 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This study will test whether a traditional Chinese medicine called Lingze tablets, when added to the standard drug tamsulosin, can better improve sleep and nighttime urination problems in men after prostate surgery. Who can participate? Men aged 50 years or older who have had transurethral holmium laser enucleation of the prostate (a minimally invasive surgery for enlarged prostate) and continue to have bothersome nighttime urination (at least 2 times per night) and other urinary symptoms may be eligible. Who cannot participate? Men who cannot tolerate the study medications, have severe cancer, serious organ failure, or have conditions that prevent them from understanding or following the study requirements. What will participants do? About 136 participants will be randomly assigned (by chance, like a coin flip) to one of two groups: Group 1: Take tamsulosin sustained-release capsul

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📋 Eligibility rules (as published)
Inclusion Criteria: * Male patients aged 50 years or older * History of transurethral holmium laser enucleation of the prostate (HoLEP) * Nocturia frequency ≥2 times per night * Documented bladder outlet obstruction * Presence of postoperative urinary incontinence and urgency symptoms * Ability to understand study procedures and provide written informed consent * Willingness to complete all scheduled follow-up visits and assessments Exclusion Criteria: * Known hypersensitivity or intolerance to tamsulosin hydrochloride, Lingze tablets, or any component of these medications * Active malignancy or severe cancer requiring treatment * Cognitive impairment, psychiatric disorder, or language barrier that prevents understanding of study requirements or completion of questionnaires * Severe multi-organ failure or dysfunction that would interfere with study participation * Previous enrollment in conflicting clinical trials within the past 30 days * Inability to comply with the medication regimen or study protocol
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What it tests

  • Tamsulosin Hydrochloride Sustained-Release Capsules
  • Lingze Tablets
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Where

1 site
The Fourth Affiliated Hospital of School of Medicine, and International School of Medicine, International Institutes of Medicine，Zhejiang University
Yiwu, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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