ITMCTR2200006535尚未招募4 期
A randomized, double-blind, placebo-controlled clinical trial on the efficacy and safety of matchless yam pills in the treatment of benign prostatic hyperplasia (spleen and kidney deficiency synd
The Second Affiliated Hospital of Tianjin University of traditional Chinese Medicine0 个研究点开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 性别
- Male
入选标准
- •(1) Diagnosed benign prostatic hyperplasia patients;
- •(2) TCM syndrome differentiation is spleen and kidney deficiency syndrome;
- •(3) Age 50 to 70 years old (including boundary value);
- •(4) The International Prostate Symptom Score (IPSS) is 8 to 19 points (including boundary value);
- •(5) After informed consent, they voluntarily participated in the trial and signed the informed consent form.
排除标准
- •(1) Select patients who have taken drugs or acupuncture treatment for benign prostatic hyperplasia within the first month;
- •(2) Combined with other diseases that can lead to micturition symptoms or changes in urinary flow rate, such as neurogenic bladder, bladder neck fibrosis, bladder urinary calculi, urethral stricture, phimosis or penile tumor, acute prostatitis, prostate cancer, acute and chronic urinary tract infection, acute and chronic renal failure, etc;
- •(3) Previous prostate surgery, including transurethral resection of the prostate, transurethral enucleation of the prostate, transrectal high-intensity focused ultrasound, transurethral needle ablation, balloon dilatation, stent replacement, or other invasive treatment of benign prostatic hyperplasia;
- •(4) Patients who plan to undergo minimally invasive treatment or surgical treatment of prostate;
- •(5) Patients with long-term use of drugs that affect bladder function: a- Adrenoceptor agonists (such as norepinephrine, pseudoephedrine, deoxyepinephrine); Cholinergic drugs (neostigmine); Anticholinergic drugs (such as atropine, scopolamine, anisodamine, etc.) or other drugs that affect urination function;
- •(6) Patients whose ALT and AST are 1.5 times higher than the upper limit of normal value, or whose Cr is higher than the upper limit of normal value;
- •(7) Patients with other serious cardiovascular, cerebrovascular, liver, kidney, malignant tumors, hematological diseases, and mental diseases;
- •(8) Those who are allergic to the ingredients of the test drug or have a history of drug abuse;
- •(9) Patients who participated in other clinical trials within 3 months before screening;
- •(10) The investigator judged the patients who were not suitable to participate in this trial.
研究者
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