Lower Urinary Tract Symptoms (LUTS)
Conditions
Keywords
LUTS
Brief summary
The goal of this study is to evaluate the effects of Macanity on urinary health in males experiencing LUTS. Males aged over 40 years of age who experience LUTS will be recruited and assigned to a study treatment which they will take for 12 weeks. They will have 3 remote visits over 12 weeks.
Interventions
DIETARY_SUPPLEMENTMaca Root
Participants will take 2 capsules daily for 12 weeks, total daily dose of 290mg Macanity.
OTHERPlacebo
Participants will take 2 capsules of placebo daily for 12 weeks.
Sponsors
RDC Clinical Pty Ltd
Laboratoires Expanscience SAS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
40 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adult males \> 40 years of age experiencing LUTS * Generally healthy * BMI 18-32 kg/m2 * Moderate International Prostate Symptom Score (IPSS) score: 8-19. * IPSS quality of life (QoL) score \>3 * Able to provide informed consent * Agree to not participate in another clinical trial while enrolled in this trial
Exclusion criteria
* Have a serious illness e.g. mood disorders such as depression or bipolar disorder, anxiety, neurological disorders such as MS, kidney disease, liver disease, heart conditions, hypertension * Have an unstable illness e.g. diabetes and thyroid gland dysfunction, uncontrolled hypertension with diastolic blood pressure \> 100 mmHg * Prostate specific antigen (PSA) testing \> 2 years ago * Have used a drug/supplement for benign prostatic hyperplasia (BPH) or other urological symptoms within the last 30 days * Have had a urinary infection in the last 30 days or have, chronic urinary tract infections, or diagnosed chronic prostatitis * 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) * Current malignancy including prostatic cancer (excluding Basal Cell Carcinoma) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years * Currently taking Coumadin (Warfarin), Heparin, Dalteparin, Enoxaparin or other anticoagulation therapy including low dose aspirin; antihypertensive medications, tetracyclic antidepressants, thyroid medications * Active smokers, nicotine use or drug (prescription or illegal substances) abuse * Chronic past and/or current alcohol use (\>21 alcoholic drinks per week) * Allergic to any of the ingredients in active or placebo formula, or an allergy to cruciferous vegetables * Participants who are currently participating in any other clinical trial or who have participated in any other clinical trial during the past 1 month * Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline to the end of the study period in IPSS | Baseline to 12 weeks | Change from baseline to the end of the study period in overall IPSS score, IPSS QoL score and individual IPSS items between baseline and each assessment time. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline to the end of the study period in urinary symptoms and their effect on QoL | Baseline to 12 weeks | Change from baseline to the end of the study period in urinary symptoms and their effect on QoL via the Incontinence Quality of Life questionnaire (I-QOL). |
| Change from baseline to the end of the study period in overall improvement via the PGI-C | week 6 and week 12 | Change from baseline to the end of the study period in overall improvement via the Patient Global Impression of Change (PGI-C) questionnaire |
| Change from baseline to the end of the study period in Self-Assessment Questionnaire | Week 6, week 12 | Change from baseline to the end of the study period in Self-Assessment Questionnaire |
| Change from baseline to the end of the study period in Safety via AE monitoring | Baseline to 12 weeks | Change from baseline to the end of the study period in Safety via AE monitoring |
Countries
Australia
Contacts
CONTACTAmanda Rao
STUDY_DIRECTORGaëtan Boyer
Laboratoires Expanscience SAS
Outcome results
None listed