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Trial registered on ANZCTR


Registration number
ACTRN12615001242516
Ethics application status
Approved
Date submitted
21/10/2015
Date registered
12/11/2015
Date last updated
22/05/2018
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, Testofen, for the treatment of Benign Prostatic Hyperplasia (BPH) symptoms in otherwise healthy males.
Scientific title
A prospective, double-blind, randomised, placebo-controlled study to evaluate the efficacy of a complementary medicine formulation,
to treat symptoms of Benign Prostatic Hyperplasia (BPH) in otherwise healthy male adults.
Secondary ID [1] 287365 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Treatment of Benign Prostatic Hyperplasia (BPH) 296040 0
Condition category
Condition code
Alternative and Complementary Medicine 296310 296310 0 0
Herbal remedies
Renal and Urogenital 296986 296986 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The treatment is an ARTG listed (Aust L 187768) commercially available capsule-form herbal medicine containing 300mg Trigonella foenum-graecum (Fenugreek) seed extract. The daily dose is 2 capsules per day (total 600mg) taken with the evening meal for a period of 3 months.

Active ingredient: Trigonella foenum-graecum extract 300mg
equivalent to dry seed 9.9g

Excipient ingredients: Maltodextrin

All participants are provided with a bottle of the product (active or placebo) and a daily urinary frequency diary.

The International Prostate Symptom Score (IPSS) QOL questionnaire and the Male Sexual Health Questionnaire (MSHQ) will be administered at Baseline, Week 4, Week 8 and at trial completion (Week 12).

The Pittsburgh Sleep Quality Index will be administered at Baseline and trial completion (Week 12).

The following blood tests will also be performed to assess the affect of the product on Dihydrotesterone (DHT), Sex Hormone Binding Globulin (SHBG), serum testosterone and Prostate Specific Antigen (PSA) levels.

Adherence to the intervention will be monitored by drug tablet return.
Intervention code [1] 292705 0
Treatment: Other
Intervention code [2] 292707 0
Treatment: Drugs
Comparator / control treatment
The placebo is 2 capsules per day with the evening meal of excipient ingredients only.
Control group
Placebo

Outcomes
Primary outcome [1] 295961 0
Frequency of day time and night time urination
Day time and night time urination to be recorded at Baseline (Week 1 Day 1) until trial completion (Week 12 Day 7) using a Daily Diary.
Timepoint [1] 295961 0
Day time and night time urination to be recorded at Baseline (Week 1 Day 1) until trial completion (Week 12 Day 7) using a Daily Diary.
Primary outcome [2] 295962 0
BPH symptoms
BPH symptoms to be assessed using the International Prostate Symptom Score (IPSS) QOL questionnaire at Baseline, Week 4, Week 8 and trial completion (Week 12).
Timepoint [2] 295962 0
BPH symptoms to be assessed using the International Prostate Symptom Score (IPSS) QOL questionnaire at Baseline, Week 4, Week 8 and trial completion (Week 12).
Secondary outcome [1] 317059 0
Male sexual health related to lower urinary tract symptoms
Male sexual health to be assessed using the Male Sexual Health Questionnaire (MSHQ) at Baseline, Week 4, Week 8, and trial completion (Week 12).
Timepoint [1] 317059 0
Male sexual health to be assessed using the Male Sexual Health Questionnaire (MSHQ) at Baseline, Week 4, Week 8, and trial completion (Week 12).
Secondary outcome [2] 317060 0
Sleep quality
Sleep quality to be assessed using the Pittsburgh Sleep Quality Index questionnaire at Baseline and trial completion (Week 12).
Timepoint [2] 317060 0
Sleep quality to be assessed using the Pittsburgh Sleep Quality Index questionnaire at Baseline and trial completion (Week 12).
Secondary outcome [3] 317068 0
DHT
Timepoint [3] 317068 0
Levels to be assessed via blood test at Baseline and trial completion (Week 12).
Secondary outcome [4] 318829 0
SHBG
Timepoint [4] 318829 0
Levels to be assessed via blood test at Baseline and trial completion (Week 12).
Secondary outcome [5] 318830 0
Serum testosterone
Timepoint [5] 318830 0
Levels to be assessed via blood test at Baseline and trial completion (Week 12).
Secondary outcome [6] 318831 0
PSA levels
Timepoint [6] 318831 0
Levels to be assessed via blood test at Baseline and trial completion (Week 12).

Eligibility
Key inclusion criteria
* Male aged between 45-80 years
* Medically diagnosed with BPH
* Minimum score of 8 in the IPSS
* Capable of providing informed consent
* Able to attend the required clinics
Minimum age
45 Years
Maximum age
80 Years
Sex
Males
Can healthy volunteers participate?
No
Key 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 Coumadin (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)
The potential participants are screened by the investigator for inclusion in the study. The eligible participants are enrolled by investigator and provided with a "Numbered Container" that is identical to all other containers and contains the same information on the label, except for the number. The investigator is blinded to the product randomized with the
numbered containers labelled prior to delivery to investigational site. Product allocated as participants are enrolled in sequential order (1-100).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer randomized 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
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/01/2016
Actual
22/09/2016
Date of last participant enrolment
Anticipated
Actual
20/11/2017
Date of last data collection
Anticipated
Actual
20/03/2018
Sample size
Target
100
Accrual to date
Final
84
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 291925 0
Commercial sector/Industry
Name [1] 291925 0
Gencor Pacific
Country [1] 291925 0
Hong Kong
Primary sponsor type
Individual
Name
Amanda Rao
Address
Integrated Health Global Pty Ltd 3B/76 Doggett St, Newstead, QLD 4006
Country
Australia
Secondary sponsor category [1] 290590 0
Individual
Name [1] 290590 0
Suzanne Abraham
Address [1] 290590 0
The University of Sydney
Medical School
Edward Ford Building (A27)
Fisher Road
University of Sydney NSW 2006
Country [1] 290590 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293429 0
Queensland Clinical Trials Network Inc.
Ethics committee address [1] 293429 0
Level 3
88 Jephson Street
TOOWONG QLD 4066
Ethics committee country [1] 293429 0
Australia
Date submitted for ethics approval [1] 293429 0
01/09/2015
Approval date [1] 293429 0
04/03/2016
Ethics approval number [1] 293429 0
HREC2015002

Summary
Brief summary
This is a double-blind, randomised, placebo-controlled study to evaluate the effect of a herbal extract. The aim is to investigatge if the formulation treats benign prostatic hyperplasia (BPH) symptoms in otherwise healthy males.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 57062 0
Ms Amanda Rao
Address 57062 0
Integrated Health Global Pty Ltd 3B/76 Doggett St, Newstead, QLD 4006
Country 57062 0
Australia
Phone 57062 0
+61 414 488 559
Fax 57062 0
Email 57062 0
[email protected]
Contact person for public queries
Name 57063 0
Ms Amanda Rao
Address 57063 0
Integrated Health Global Pty Ltd 3B/76 Doggett St, Newstead, QLD 4006
Country 57063 0
Australia
Phone 57063 0
+61 414 488 559
Fax 57063 0
Email 57063 0
[email protected]
Contact person for scientific queries
Name 57064 0
Ms Amanda Rao
Address 57064 0
Integrated Health Global Pty Ltd 3B/76 Doggett St, Newstead, QLD 4006
Country 57064 0
Australia
Phone 57064 0
+61 414 488 559
Fax 57064 0
Email 57064 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

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