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Single-armed, open, multi-center Phase IV clinical trials of Huang'e Capsules in treating benign prostatic hyperplasia

Single-armed, open, multi-center Phase IV clinical trials of Huang'e Capsules in treating benign prostatic hyperplasia

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OIC-17011288
Enrollment
Unknown
Registered
2017-05-04
Start date
2014-06-24
Completion date
Unknown
Last updated
2017-05-09

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

Conditions

Benign prostatic hyperplasia

Interventions

test group:using Huange capsules

Sponsors

First Affiliated Hospital of Zhejiang University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
40 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Western medicine by clinical diagnosis confirmed benign prostatic hyperplasia; 2. TCM dialectical classification for Qi deficiency and blood stasis, damp-heat syndrome; 3. Male subjects aged between 40 and 85 (including 40 and 85 years); 4. Nearly three months, transabdominal prostate B ultrasound measurement, prostate weight greater than 20g (calculation formula: prostate weight m = 0.546 × prostate triangular product); 5. Subjects voluntarily attend and sign informed consent.

Exclusion criteria

Exclusion criteria: 1. allergies and allergy to the drug; 2. combined with severe neurological diseases, lumbar disc herniation, spinal stenosis, lower abdomen and pelvic surgery, severe diabetes and other causes of neurogenic bladder disease; 3. combined with bladder new creatures, ureteral ridge, fine Fu hypertrophy, bladder neck sclerosis; Blood PSA> 4ng / ml; (ALT> 1.5 × ULN, AST> 1.5 × ULN), renal function (Cr> 1.5 × ULN) or combined with cardiovascular and cerebrovascular, liver, kidney, hematopoietic system and other serious primary diseases, Serious diseases that affect their survival, such as cancer or AIDS; 6. severe gastritis, stomach and duodenal ulcer; 7. severe renal dysfunction, urinary retention in patients; 8. According to the researchers' judgment, there are other diseases that reduce the possibility of grouping or complicate the group, such as frequent changes in the working environment and so on. 9. Other circumstances that the investigator considers unsuitable for inclusion.

Design outcomes

Primary

MeasureTime frame
I-PSS;

Secondary

MeasureTime frame
Quality of life score;Maximum urinary flow rate;Prostate volume;

Countries

China

Contacts

Public ContactShaobo Jiang

Zhejiang University of Traditional Chinese Medicine Affiliated First Hospital

JSB209@163.com+86 13588887293

Outcome results

None listed

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