Evidence-Based Complementary and Alternative Medicine

Research Article

Effects of a Proprietary Freeze-Dried Water Extract of Eurycoma longifolia (Physta) and Polygonum minus on Sexual Performance and Well-Being in Men: A Randomized, Double-Blind, Placebo-Controlled Study

Table 2

Visit details.
 V1 V1.5V2 V3V4
 Screening visit Baseline Visit  
 week 2 Week 0Week 6Week 12
Protocol activity     
 Informed consentxRandomization assignment and paperwork———
 Inclusion/exclusionx———
 Medical/medication historyx———
 Intercurrent medical issues/AE review—xxx
 Review concomitant therapiesxxxx
 Physical examination (including prostate exam)x——x
 Randomization—x——
 Vital signsxxxx
 Anthropomorphic measuresx—xx
 BIA—xxx
 Dispense bodymedia armband—xxx
 Dispense subject diariesxxx—
 Collect subject diaries—xxx
 Dispense product—xx—
 Pill count/compliance assessment——xx
Administer scales and questionnaires    
 Benign prostate hyperplasia (BPH) symptom scorex———
 Index of erectile function (IIEF-5)xxxx
 Erectile dysfunction inventory for treatment satisfaction (EDITS) questionnaire——xx
 Sexual health inventory questionnairex———
 Aging males symptom score (AMS)—xxx
 Self-esteem and relationship questionnaire (SEAR)—xxx
 Beck depression indexxxxx
 Beck anxiety indexxxxx
 Alcohol/compliance questionnaire x———
Laboratory    
 Total + free testosteronex—xx
 CBCx——x
 CMPx——x
 UAx——x