Health TrialsbyHealthPanel

Effects of Macanity on Urinary Health in Males With Lower Urinary Tract Symptoms

ConditionLower Urinary Tract Symptoms (LUTS)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age40+
SponsorRDC Clinical Pty Ltd

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Adult males > 40 years of age experiencing LUTS

Generally healthy

BMI 18-32 kg/m2

Moderate International Prostate Symptom Score (IPSS) score: 8-19.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Maca Root

    Dietary supplement

    Participants will take 2 capsules daily for 12 weeks, total daily dose of 290mg Macanity.

  • Placebo

    Other intervention

    Participants will take 2 capsules of placebo daily for 12 weeks.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: MacanityExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change from baseline to the end of the study period in IPSS

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.

Time frame
Baseline to 12 weeks

Secondary outcomes

1

Change from baseline to the end of the study period in urinary symptoms and their effect on QoL

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).

Time frame
Baseline to 12 weeks
2

Change from baseline to the end of the study period in overall improvement via the PGI-C

Change from baseline to the end of the study period in overall improvement via the Patient Global Impression of Change (PGI-C) questionnaire

Time frame
week 6 and week 12
3

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 Self-Assessment Questionnaire

Time frame
Week 6, week 12
4

Change from baseline to the end of the study period in Safety via AE monitoring

Change from baseline to the end of the study period in Safety via AE monitoring

Time frame
Baseline to 12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

RDC Clinical Pty Ltd

Lead sponsor

Laboratoires Expanscience SAS

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: