Erectile dysfunction Erectile dysfunction Mucuna pruriens var. pruriens IIEF-5 Cross-over study
Conditions
Interventions
Oral administration of 1,500 mg/day M. pruriens seed extract for 6 weeks, taken as 500 mg three times a day.,Oral administration of 1,500 mg/day Placebo for 6 weeks, taken as 500 mg three times a day.
Experimental Drug,Placebo Comparator Drug
M. pruriens seed extract,Placebo
Sponsors
Faculty of Medicine, Chiang Mai University
Eligibility
Sex/Gender
Male
Age
20 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Male participants aged 20-60 years, who can read and write Thai, 2. Have had erectile dysfunction problems for at least 3 months, 3. Have mild and mild to moderate erectile dysfunction (a score of 12 - 21 on the International Index of Erectile Function (IIEF-5) questionnaire), 4. Willing to have sex at least 1 time in 2 weeks throughout the study, 5. Agree not to use other methods of treating erectile dysfunction including other herbs throughout the study period, 6. Research participants must be informed of the details of the clinical study, including risks and side effects that may occur during the study period, both verbally and in writing. They must sign the consent form to participate in the research voluntarily.
Exclusion criteria
Exclusion criteria: 1. Currently using phosphodiesterase-5 inhibitors or have stopped using them for less than 1 week, 2. Erectile dysfunction caused by nerve injury due to spinal cord injuries or surgery on the colon, rectum, prostate, bladder, etc., 3. A history of being allergic to M. pruriens., 4. Smoke more than 20 cigarettes per day, 5. Have heart disease, 6. Have kidney disease, 7. Have uncontrolled hypertension, 8. Patients with uncontrolled diabetes, 9. Have uncontrolled hypercholesterolemia, 10. Have ever had surgery or radiation on the pelvic region or other conditions that may affect the effectiveness of M. pruriens seed extract, 11. Have cancer, 12. Have clinically significant abnormalities in the results of routine laboratory tests.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Erectile dysfunction severity at week 0, 2, 4, 6 IIEF-5 | — |
Secondary
| Measure | Time frame |
|---|---|
| Erectile hardness at week 0, 2, 4, 6 Erectile hardness score ,Quality of life at week 0. 2, 4, 6 WHOQOL-BRIEF-THAI ,Treatment satisfaction at week 0, 2, 4, 6 VAS,Testosterone level at week 0 and 6 Measure testosterone in serum,L-dopa level at week 0, 6 Measure L-dopa in plasma,Safety at week 0, 2, 4, 6 Evaluate complete blood counts, BUN and creatinine levels, electrolytes, liver function test | — |
Countries
Thailand
Contacts
Public ContactNutthiya Hanprasertpong
Department of Pharmacology, Faculty of Medicine, Chiang Mai University
Outcome results
None listed