The purpose of this study was to evaluate the overall efficacy and safety of Kaempferia parviflora in overall healthy male human subjects.
This study was an open label safety and efficacy study. Each subject received a specific dose of a formulation containing Kaempferia parviflora. There would be attempted telephone or e-mail contact in 2 weeks following enrollment. Participants would undergo assessments of blood tests, vital signs, body weight with completion of questionnaires. The primary objective was to assess the effect of Kaempferia parviflora on erectile function among overall healthy males age 50 to 70.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
14
IIEF (International Index of Erectile Dysfunction) questionnaire scores
Mean change in IIEF scores. There are five specific areas addressed including Erectile Function (questions:1-5 \& 15;score range: 0-5, maximum score:30); Orgasmic Function (questions:9-10; score range:0-5; maximum score:10); Sexual desire (questions:11-12; score range:1-5; maximum score:10); Intercourse satisfaction (questions:6-8; score range:0-5; maximum score:15); Overall satisfaction (questions:13-14; score range:1-5; maximum score:10). The lower the score represents greater dysfunction within each domain.
Time frame: 30 days
GAQ (Global Assessment Question)
Response (yes or no) from Global Assessment Question
Time frame: 30 days
Levels of Free Testosterone
Mean change in Free Testosterone levels in pg/ml
Time frame: 30 days
Levels of Total Testosterone
Mean change in Total Testosterone levels in ng/dl
Time frame: 30 days
Levels of Estradiol
Mean change in Estradiol levels in pg/ml
Time frame: 30 days
Levels of DHEA-S
Mean change in DHEA-S levels in ug/dl
Time frame: 30 days
Levels of PSA
Mean change in PSA levels in ng/ml
Time frame: 30 days
Levels of Total Cholesterol
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Mean change in Total Cholesterol levels in mg/dl
Time frame: 30 days
Levels of LDL Cholesterol
Mean change in LDL Cholesterol levels in mg/dl
Time frame: 30 days
Levels of HDL Cholesterol
Mean change in HDL Cholesterol levels in mg/dl
Time frame: 30 days
Levels of Triglycerides
Mean change in Triglyceride levels in mg/dl
Time frame: 30 days
Body Mass Index
Mean change in body mass index in kg/m\^2 calculated by formula using the body weight (lb.) and the height (in.)
Time frame: 30 days