Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001074684
Ethics application status
Approved
Date submitted
26/09/2014
Date registered
7/10/2014
Date last updated
28/09/2016
Type of registration
Prospectively registered

Titles & IDs
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.
Secondary ID [1] 283830 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Benign Prostatic Hypertrophy 290808 0
Condition category
Condition code
Alternative and Complementary Medicine 291176 291176 0 0
Herbal remedies
Renal and Urogenital 293463 293463 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 288516 0
Treatment: Other
Comparator / control treatment
1 tablet (maltodextrin) per day taken with the evening meals for 12 weeks
Control group
Placebo

Outcomes
Primary outcome [1] 291165 0
Day-time and night time urinary frequency - Assessed using a 1 week Patient Daily Diary.
Timepoint [1] 291165 0
Baseline, month 1, month 2 and month 3
Primary outcome [2] 291167 0
Symptoms of BPH - Assessed by the IPSS (International Prostate Symptom Score)

Timepoint [2] 291167 0
Baseline, month 1, month 2 and month 3
Secondary outcome [1] 306163 0
Sleep quality - Assessed by the Pittsburgh Sleep Questionnaire

Timepoint [1] 306163 0
Baseline, month 1, month 2 and month 3
Secondary outcome [2] 310712 0
Hormones - Sex hormone binding globulin (SHBG) and Serum testosterone levels - assessed by blood test
Timepoint [2] 310712 0
Baseline and week 12

Eligibility
Key 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
Minimum age
45 Years
Maximum age
80 Years
Sex
Males
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Approximately 100 male subjects aged between 45-80 years of age will be recruited from databases and public media outlets. Following preliminary screening via telephone, potential subjects will attend the clinic for an information session and will be requested to provide their consent for inclusion in the trial. Consenting potential subjects will undergo a medical assessment including lifestyle, current medications, physical assessment and medical history; this data will be used for the comprehensive screening and to provide contextual data for the study.

The trial product is sent to already randomised and in numbered containers (001-100) so administering staff are blinded to allocation.

Once enrolled in the trial, participants will be randomly allocated to either the placebo comparator group (n=50) or the active intervention group (n=50). Enrolled participants will be allocated a sequential number from 0001 to 0100 determined by the order in which they are enrolled. Subjects will be allocated a (randomised) TPC that corresponds with their allocation number; for example, participant 0034 will receive TPC 0034.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation code used to identify TPCs is a sequential number (0001 to 00100) generated by the Random Allocation Software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
19/01/2015
Actual
19/10/2015
Date of last participant enrolment
Anticipated
14/03/2016
Actual
1/05/2016
Date of last data collection
Anticipated
Actual
28/07/2016
Sample size
Target
100
Accrual to date
Final
106
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 8734 0
4005 - New Farm

Funding & Sponsors
Funding source category [1] 290012 0
Commercial sector/Industry
Name [1] 290012 0
Gencor Pacific
Country [1] 290012 0
Hong Kong
Primary sponsor type
Commercial sector/Industry
Name
Integrated Health Group Pty. Ltd.
Address
188 James Street
New Farm Brisbane 4005 QLD
Country
Australia
Secondary sponsor category [1] 288700 0
None
Name [1] 288700 0
Address [1] 288700 0
Country [1] 288700 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291719 0
Queensland Clinical Trial Network Ethics Committee
Ethics committee address [1] 291719 0
Level 3, 88 Jephson Street
Toowong, QLD, 4066
Ethics committee country [1] 291719 0
Australia
Date submitted for ethics approval [1] 291719 0
30/09/2014
Approval date [1] 291719 0
08/12/2014
Ethics approval number [1] 291719 0

Summary
Brief 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.
Trial website
www.integratedhealthgroup.com.au
Trial related presentations / publications
Nil
Public notes
nil

Contacts
Principal investigator
Name 45250 0
Dr Elizabeth Steels
Address 45250 0
Integrated Health Group Pty. Ltd. 188 New Farm New Farm, Brisbane QLD 4005
Country 45250 0
Australia
Phone 45250 0
+61 7 31620909
Fax 45250 0
Email 45250 0
[email protected]
Contact person for public queries
Name 45251 0
Dr Elizabeth Steels
Address 45251 0
Integrated Health Group Pty. Ltd. 188 James Street New Farm, Brisbane QLD 4005
Country 45251 0
Australia
Phone 45251 0
+61 7 31620909
Fax 45251 0
Email 45251 0
[email protected]
Contact person for scientific queries
Name 45252 0
Dr Elizabeth Steels
Address 45252 0
Integrated Health Group Pty. Ltd. 188 James Street New Farm, Brisbane QLD 4005
Country 45252 0
Australia
Phone 45252 0
+61 7 31620909
Fax 45252 0
Email 45252 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAgeratum conyzoides L. inhibits 5-alpha-reductase gene expression in human prostate cells and reduces symptoms of benign prostatic hypertrophy in otherwise healthy men in a double blind randomized placebo controlled clinical study.2017https://dx.doi.org/10.1002/biof.1389
N.B. These documents automatically identified may not have been verified by the study sponsor.