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 syndrome)

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ITMCTR

Registry ID

ITMCTR2200006535

Enrollment

Unknown

Registered

2022-08-24

Start date

2022-09-10

Completion date

Unknown

Last updated

2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostatic hyperplasia

Interventions

treatment group:Incomparable yam pill

control group:Placebo of incomparable yam pills

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: (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.

Exclusion criteria

Exclusion criteria: (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.

Design outcomes

Primary

Measure	Time frame
IPSS;	—

Secondary

Measure	Time frame
Residual urine volume of bladder;Quality of life score;TCM syndrome score;Maximum urinary flow rate;Use of emergency drugs;Prostate volume;	—

Countries

China

Contacts

Public ContactGu Xufang

guxf218@163.com13821724681

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026