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.

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12614001074684
• Date of registration: 07/10/2014
• Prospective Registration: Yes
• Primary sponsor: Integrated Health Group Pty. Ltd.
• Public title: 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.
• Scientific title: 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.
• Date of first enrolment: 19/10/2015
• Target sample size: 100
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12614001074684.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Safety/efficacy;
• Phase: Phase 3 / Phase 4

Countries of recruitment

Australia

Contacts

• Name: Dr Elizabeth Steels

• Name: Dr Elizabeth Steels

Key inclusion & exclusion criteria

Inclusion criteria: Inclusion Criteria

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



Exclusion criteria: Exclusion criteria

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


Age minimum: 45 Years
Age maximum: 80 Years
Gender: Males

Health Condition(s) or Problem(s) studied

Alternative and Complementary Medicine - Herbal remedies

Renal and Urogenital - Other renal and urogenital disorders

Benign Prostatic Hypertrophy;
Benign Prostatic Hypertrophy

Intervention(s)

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.

Primary Outcome(s)

Day-time and night time urinary frequency - Assessed using a 1 week Patient Daily Diary.[Baseline, month 1, month 2 and month 3]

Symptoms of BPH - Assessed by the IPSS (International Prostate Symptom Score)

[Baseline, month 1, month 2 and month 3]

Secondary Outcome(s)

Hormones - Sex hormone binding globulin (SHBG) and Serum testosterone levels - assessed by blood test[Baseline and week 12]

Sleep quality - Assessed by the Pittsburgh Sleep Questionnaire

[Baseline, month 1, month 2 and month 3]

Secondary ID(s)

nil

Source(s) of Monetary Support

Gencor Pacific

Ethics review

Status: Approved
Approval date:
Contact:

Queensland Clinical Trial Network Ethics Committee