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Trial registered on ANZCTR


Registration number
ACTRN12610000168055
Ethics application status
Approved
Date submitted
12/02/2010
Date registered
19/02/2010
Date last updated
5/08/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
A study looking at the effectiveness of a oral herbal supplement for helping to manage the symptoms of enlarged prostate
Scientific title
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.
Secondary ID [1] 1423 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Benign Prostatic Hypertrophy 256762 0
Condition category
Condition code
Alternative and Complementary Medicine 256912 256912 0 0
Herbal remedies
Renal and Urogenital 256913 256913 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 255974 0
Treatment: Other
Comparator / control treatment
Per capsule:
Lecithin 7mg
vegetable oil 90mg
Beeswax 30mg
Soya oil 593mg

Gelatin Capsules wiht glycerol, Opatint Blue and Opatint White

Dosage: One capsule (oral) per day before meals for 12 weeks duration.
Control group
Placebo

Outcomes
Primary outcome [1] 257788 0
A reduction in the International Prostate Symptom Score (IPSS) to assess efficacy of preparation on symptoms of benign prostatic hypertrophy
Timepoint [1] 257788 0
baseline
1 month
2 month
3 month
Secondary outcome [1] 263191 0
Evaluate saftey and tolerability of herbal preparation assessed through patient diaries and reports of side effects and through Liver Function Tests (LFT) (pathology testing) and electrolytes (pathology testing).
Timepoint [1] 263191 0
baseline
1 month
2 month
3 month
Secondary outcome [2] 263192 0
Assess effect of herbal preparation on serum prostate specific antigen (PSA) levels (pathology testing).
Timepoint [2] 263192 0
baseline
1 month
2 month
3 month
Secondary outcome [3] 263193 0
Assess effect of herbal preparation in reducing the sensation of not emptying bladder completely after finished urinating assessed through scoring on IPSS questionnaire.
Timepoint [3] 263193 0
baseline
1 month
2 month
3 month
Secondary outcome [4] 263257 0
Assess effect of herbal preparation in reducing freqeuncy of urination any time of the day assessed through scoring on IPSS queestionnaire.
Timepoint [4] 263257 0
baseline
1 month
2 month
3 month
Secondary outcome [5] 263258 0
Assess effect of herbal preparation in reducing the frequency of stopping and starting several time during urination assessed through scoring on the IPSS questionnaire.
Timepoint [5] 263258 0
baseline
1 month
2 month
3 month
Secondary outcome [6] 263259 0
Assess the effect of the herbal preparation in improving the ability to postpone urination assessed through scoring on the IPSS questionnaire.
Timepoint [6] 263259 0
baseline
1 month
2 month
3 month
Secondary outcome [7] 263260 0
Assess ability of herbal preparation in strengthening urinary flow aassess through scoring on the IPSS questionnaire.
Timepoint [7] 263260 0
baseline
1 month
2 month
3 month
Secondary outcome [8] 263261 0
Assess the effect of the herbal preparation in improving symptoms of pushing or straining to begin urination assess through scoring on the IPSS questionnaire.
Timepoint [8] 263261 0
baseline
1 month
2 month
3 month
Secondary outcome [9] 263262 0
Assess the effect of the herbal preparation in reducing the frequency of night time urination assessed through scoring on the IPSS questionnaire.
Timepoint [9] 263262 0
baseline
1 month
2 month
3 month

Eligibility
Key inclusion criteria
1. Male aged between 40-80 years
2. Medically diagnosed with benign prostatic hypertrophy
3. Minimum score of 8 on the IPSS
Minimum age
40 Years
Maximum age
80 Years
Sex
Males
Can healthy volunteers participate?
No
Key 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.

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)
An initial preliminary screening via telephone. potential participants will be required to attend the clinic for an information session and to provide consent.
Participants will be allocated to an intervention according to their sequence of enrolement.
Randomisation was performed by an independent company using Random Allocation Software, version 1.0, May 2004. Randomisatrion was based on a total of 60 subjects, randomly allocated to either Active or Placebo arms of equal numbers of subjects (n=30). The randomisation code will be maintained by the independent company.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be performed using Random Allocation Software, version 1.0 by an independent company.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
68
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2579 0
4000
Recruitment postcode(s) [2] 2580 0
4010
Recruitment postcode(s) [3] 2581 0
4015
Recruitment postcode(s) [4] 2582 0
4020
Recruitment postcode(s) [5] 2583 0
4030
Recruitment postcode(s) [6] 2584 0
4040
Recruitment postcode(s) [7] 2585 0
4050
Recruitment postcode(s) [8] 2586 0
4060
Recruitment postcode(s) [9] 2587 0
4065
Recruitment postcode(s) [10] 2588 0
4070
Recruitment postcode(s) [11] 2589 0
4025
Recruitment postcode(s) [12] 2590 0
4035
Recruitment postcode(s) [13] 2591 0
4045
Recruitment postcode(s) [14] 2592 0
4055

Funding & Sponsors
Funding source category [1] 256474 0
Commercial sector/Industry
Name [1] 256474 0
Totally Natural Products
Country [1] 256474 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Totally Natural Products
Address
13-14 Durian Place
Wetherill Park B.C.
NSW 1851
Country
Australia
Secondary sponsor category [1] 255782 0
None
Name [1] 255782 0
Address [1] 255782 0
Country [1] 255782 0
Other collaborator category [1] 1113 0
Commercial sector/Industry
Name [1] 1113 0
Applied Science and Nutrition
Address [1] 1113 0
188 James street
New Farm
QLD 4005
Country [1] 1113 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258525 0
Endevour College of Natural Health
Ethics committee address [1] 258525 0
Ethics committee country [1] 258525 0
Australia
Date submitted for ethics approval [1] 258525 0
01/09/2009
Approval date [1] 258525 0
01/11/2009
Ethics approval number [1] 258525 0
HREC028

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30808 0
Address 30808 0
Country 30808 0
Phone 30808 0
Fax 30808 0
Email 30808 0
Contact person for public queries
Name 14055 0
Elizabeth Steels
Address 14055 0
188 James street
New Farm
QLD 4005
Country 14055 0
Australia
Phone 14055 0
+61 7 3162 0909
Fax 14055 0
+61 7 3852 6183
Email 14055 0
[email protected]
Contact person for scientific queries
Name 4983 0
Elizabeth Steels
Address 4983 0
188 James street
New Farm
QLD 4005
Country 4983 0
Australia
Phone 4983 0
+61 7 3162 0909
Fax 4983 0
+61 7 3852 6183
Email 4983 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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