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A Randomized Controlled Clinical Study of Tu-Ling Formula in the Treatment of Benign Prostatic Hyperplasia with Kidney Essence Deficiency and Dampness Obstruction in the Seminal Chamber

A Randomized Controlled Clinical Study of Tu-Ling Formula in the Treatment of Benign Prostatic Hyperplasia with Kidney Essence Deficiency and Dampness Obstruction in the Seminal Chamber

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001740
Enrollment
Unknown
Registered
2025-09-15
Start date
2025-09-15
Completion date
Unknown
Last updated
2025-10-13

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

Conditions

Benign prostatic hyperplasia

Interventions

Tu-Ling Formula group:Tu-Ling Formula
control group:Tamsulosin

Sponsors

Xiyuan Hospital,China Academy of Tradiional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
50 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Meeting the Western diagnostic criteria for Benign Prostatic Hyperplasia (BPH); 2.Male aged 50–75 years; 3.Disease duration >3 months; 4.International Prostate Symptom Score (IPSS) indicating moderate symptoms (8 = IPSS = 19), with Quality of Life (QOL) score >3; 5.Meeting TCM diagnostic criteria for Kidney Essence Deficiency and Dampness Obstruction in the Seminal Chamber; 6.Having signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with concurrent prostate cancer or suspected prostate malignancy (prostate-specific antigen, PSA > 4 ng/mL); 2. Patients with neurogenic bladder, bladder neck fibrosis, bladder cancer, urinary tract infectionor prior transurethral surgery; 3. Patients requiring surgical intervention due to indications including: refractory urinaryretention caused by obstruction, recurrent cystitis, bladder stones, or persistent hematuria4. History of hypotension, heart disease, malignancy, gastric ulcer, hemorrhagic disorders, orpsychiatric illnesses; 5. History of severe chronic or acute hepatitis 6.Significant hepatic or renal dysfunction defined as: o AST and/or ALT >1.5 x upper limit of normal (ULN); o Creatinine and/or blood urea nitrogen (BUN)> ULN;7. Uncontrolled diabetes mellitus (fasting blood glucose > 1.5 x ULN) or with diabeticcomplications (e.g. diabetic nephropathy, peripheral neuropathy);8. Use of BPH-related medications within the past two weeks;9. Chronic use of drugs affecting bladder function (e.g., anticholinergics, psychoactive agents); 10. Known drug allergies.

Design outcomes

Primary

MeasureTime frame
International Prostate Symptom Score;—

Secondary

MeasureTime frame
Maximum flow rate of urine;TCM syndrome score;Quality of Life Score;residual urine volume;Prostate volume;—

Countries

china

Contacts

Public Contactwenxiao yu

Xiyuan Hospital,China Academy of Tradiional Chinese Medicine

yuwenxiao2019@163.com18811563875

Outcome results

None listed

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