Erectile Dysfunction Erectile Dysfunction
Conditions
Interventions
A dose of two herbal extract capsules with 400 mg per capsule and extraction ratio of crude to extract being 3.3:1 is administered twice a day before breakfast and supper. During the intervention,
each participant consumes four capsules per day as well as placebo group. The total amount of daily intake equals to 1,
600 mg per day of herbal extract. ,Placebo medication corresponds to the active medication without the herbal extract. Placebo,
with the same size,
color and label,
is prepared as a 400 mg per capsule composed of lactose.
Experimental Drug,Placebo Comparator No treatment
Sponsors
none
Eligibility
Sex/Gender
Male
Age
50 Years to 69 Years
Inclusion criteria
Inclusion criteria: married men between 50-69 years old or those with stable chronic medical illnesses, such as, controlled diabetes mellitus and/or hypertension. Besides, those suffering from ED symptoms at least 6 months, having stable heterosexual relationship for at least 6 months, both partners agreeing to attempt intercourse at least once a week on average during the study, and those with bioavailable testosterone 40-190 ng/dL and IIEF-5 score 11-21 (mild to moderate ED) are also included. Participants with the following conditions are excluded: history of major hematological, renal or hepatic disorder, stroke or myocardial infraction and cardiovascular disease within the last six months, peptic ulcer or bleeding disorder, history of prostate cancer, elevated prostate specific antigen (PSA ≥ 4 ng/ ml), major uncontrolled psychiatric disorder, penile anatomical abnormalities, primary hypoactive sexual desire, history of alcohol or drug abuse, resting hypotension (resting systolic blood pressure 170 mmHg or diastolic pressure > 110 mmHg), body mass index BMI over 30 kg per m2, using herbal products or drugs that contain testosterone or any androgenic activity in the last month before the trial starts, Thyroid stimulating hormone TSH,T3,T4.
Exclusion criteria
Exclusion criteria: Abnormal and history of herbal allergy. However, during the study period, participants who experience abnormal prostate exam during the screening visit study controls and are unable to comply with the scheduled treatment dose of at least 80% of the dose are terminated.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Erectile Dysfunction at 12 weeks after end of the intervention Scores of International Index of Erectile Function and Scale for Quality of Sexual Function ,Qualitative 12 weeks The sleep quality is assessed by the Pittsburgh Sleep Quality Index (PSQI) | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety 8 weeks physical examination, clinical and laboratory test | — |
Countries
Thailand
Contacts
Public ContactJunya Pattara-archachai
Sripatum University
Outcome results
None listed