A study looking at the effectiveness of a oral herbal supplement for helping to manage the symptoms of enlarged prostate

A double-blind, randomised, placebo-controlled study of the efficacy of an orally-dosed herbal formulation for the treatment of benign prostatic hypertrophy (BPH) symptoms.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000168055

Enrollment

Registered

2010-02-19

Start date

2010-02-01

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

The primary purpose of the study is to assess whether this herbal preparation can manage and improve the symptoms associated with BPH such as increased frequency of urination, difficulties with starting stopping urination and difficulties in postponing urination.

Interventions

Per Capsule Prunus Africanum stem bark: 15,000mg Cucubita pepo seed oil: 160mg Epilobium parviflorum: 500mg Seronoa repens seed: 660mg Lycopene: 2.1mg Excipients: Lecithin Vegetable oil Beeswax Soya oil Gelatin Capsules with glycerol, Opatint Blue and Opatint White Dosage One capsule (oral) per day before meals for 12 weeks duration.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

Male

Age

40 Years to 80 Years

Healthy volunteers

Inclusion criteria

1. Male aged between 40-80 years 2. Medically diagnosed with benign prostatic hypertrophy 3. Minimum score of 8 on the IPSS

Exclusion criteria

1. Use of a drug/natural therapy for BPH or other urological symptoms within 30 days of starting the trial. 2. Recently starting a bladder training program. 3. Urogenital surgery within the last 6 months. 4. A bladder biopsy and/or cystoscopy and biopsy within 30 days of starting the trial. 5. An indwelling catheter or practice of self-catheterisation. 6. Diagnosis of chronic persistant local pathology (i.e. interstitual cystitis, bladder stones). 7. Currently taking Warfarin or other anti-coagulant therapies. 8. Diagnosis of hypertension and recieving prescribed antihypertenive medications. 9. Diagnosis with severe renal and/or hepatic insufficiency. 10. Diagnosed with genital anatomical deformaties, uncontrolled diabetes, history of spinal cord injury and uncontrolled psychiatric disorders.

Outcome results