Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:39 PM
Ignite Modification Date:
2025-12-24 @ 9:39 PM
NCT ID:
NCT02886832
Brief Summary:
The purpose of this study is to assess the efficacy of a Prostate Health formulation on scores attained from the I-PSS questionnaire. Safety and tolerability of the formulation will also be assessed.
Detailed Description:
This study is a pilot, open-label study to evaluate the efficacy, safety and tolerability of a Prostate Health formulation. Each subject will receive a specific dose of the formulation once daily.
Participants will undergo assessments of blood tests, vital signs, body weight, BMI with completion of questionnaires.
The primary objective of the study is to assess effectiveness of the Prostate Health formulation on the I-PSS score.
Secondary objectives:
1. To assess the I-PSS "Quality of Life" question score
2. To assess the PSA level
3. To assess the IIEF-5 questionnaire score
4. To assess body weight
5. To assess BMI
6. To assess the score on a questionnaire for health-related quality of life
Study:
NCT02886832
Study Brief:
Protocol Section:
NCT02886832