CompletedPhase 3Phase 4ACTRN12614001074684

A double-blind, randomised, placebo-controlled study to evaluate the effect of an orally-dosed herbal extract, Ageratum conyzoides, for the treatment of benign prostatic (BPH) symptoms in otherwise healthy males.


Sponsor

Integrated Health Group Pty. Ltd.

Enrollment

100 participants

Start Date

Oct 19, 2015

Study Type

Interventional

Conditions

Summary

The study aims to assess the effectiveness of Ageratum conyzoides on day-time and night time urinary frequency, symptoms of BPH, sleep quality and on SHBG and serum testosterone levels. Due to the ant-inflammatory and analgesic actions of Ageratum conyzoides, it has a long history of use traditionally in Caribbean folk medicine for a number of men’s health issues including prostate and urinary problems. The investigational product is a tablet - form herbal medicine, containing 250mg of Ageratum conyzoides extract. The daily dose will be 1 capsule per day taken with the evening meal, taken over 3 consecutive months.


Eligibility

Sex: MalesMin Age: 45 YearssMax Age: 80 Yearss

Inclusion Criteria4

  • Male aged between 45-80
  • Medically diagnosed with BPH
  • Minimum score of 8 in the IPSS
  • Written informed consent from the subject

Exclusion Criteria9

  • Known hypersensitivity to herbal drugs/nutritional supplement/ foods.
  • Have used a drug/natural therapy for BPH or other urological symptoms within the last 30 days.
  • Have had urogenital surgery within the last 6 months.
  • Have had bladder biopsy and/or cystoscopy and biopsy within the past 30 days.
  • Have been diagnosed with chronic persistent local pathology (e.g. interstitial cystitis, bladder stones)
  • Receiving/ prescribed coumandin (Warfarin) or other anticoagulation therapy
  • Diagnosed genital anatomical deformities, uncontrolled diabetes mellitus, and history of spinal cord injury, uncontrolled psychiatric disorder, and/or abnormal secondary sexual characteristics
  • Diagnosed prostatic cancer or benign hypertrophy; if suspected by the investigator, refer for medical assessment
  • Current or history of chronic alcohol and/or drug abuse

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Interventions

The investigational product is a tablet-form herbal medicine, containing 250mg of Ageratum conyzoides extract. The daily dose will be 1 tablet per day (250mgtaken with the evening meal for 12 weeks.

The investigational product is a tablet-form herbal medicine, containing 250mg of Ageratum conyzoides extract. The daily dose will be 1 tablet per day (250mgtaken with the evening meal for 12 weeks. Compliance will be monitored through regular email and telephone communication between interviews (fortnightly) and the return of the bottles with remaining tablets at completion of the study.


Locations(1)

QLD, Australia

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ACTRN12614001074684