Clinical trial to evaluate the effect of Rubus occidentalis on andropause symptoms
- Conditions
- Diseases of the genitourinary system
- Registration Number
- KCT0008306
- Lead Sponsor
- Berry&Bio Food Research Institue
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 30
1. Men aged between the 40 and 75 years
2. Andropause symptoms
? AMS survey result of 27 points or more
? As a result of the ADAM survey, if question 1 or 7 is yes” or 3 or more of the other questions are yes”
3. Those with TT (Total Testosterone) 2.51 ng/ml or more and 10.63 ng/ml or less
4. After listening to the detailed explanation of this clinical trial and fully understanding, a person who consented to participate in this clinical trial and signed a informed consent
1. Those who have received testosterone or testosterone inhibitors within 2 months
2. Those who received intramuscular testosterone within 6 months
3. BMI (Body Mass Index) 30 kg/m2 or more
4. T-PSA (Total Prostate Specific Antigen) 4.0 ng/ml or more
5. hyperprolactinemia (blood prolactin is 3 times or more of the upper limit of the reference range)
6. Severe acute or chronic cardio-cerebrovascular disease, metabolic disease, liver and biliary tract disease, pancreatic disease, muscle disease, neurological disease, mental disease, endocrine system disease, immune disease, kidney disease, malignant tumor, lung disease, urinary system diseases, and other diseases
7. Diagnosed with diabetes or those with an HbA1c of 6.5% or more
8. Those with hypotension below 90/50 mmHg or uncontrolled hypertension above 160/100 mmHg
9. A person who has taken medication or used treatment to improve and treat male menopause, sexual function, impotence, enlarged prostate, etc. within 2 months
10. A person who has taken health functional foods and herbal medicines to improve male menopause, sexual function, impotence, enlarged prostate, etc. within 2 weeks
11. Those who have a history of hypersensitivity or clinically significant hypersensitivity to components of drugs and products for human application
12. Those with a history of gastrointestinal diseases (e.g., Crohn's disease, etc.) or gastrointestinal surgery (except for simple appendectomy or hernia surgery) that may affect the absorption of products for clinical trial
13. Those with a history of alcoholism or substance abuse
14. Those who have been diagnosed with antipsychotics or who have received drug treatment within 2 months
15. Those who participated in other clinical trials within 2 months
16. Lab test
- AST, ALT > 3 times or more of the upper limit of the reference range
- Serum creatinine > 2.0 mg/dl
17. A person who determines that the investigator is inappropriate for clinical trial
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ASM survey
- Secondary Outcome Measures
Name Time Method IPSS survey, ADAM survey;hormone index(TT, FT, BT, SHBG, FSH, LH), lipid index(TC, TG, HDL-C, LDL-C), body measurements index(body weight, BMI, BFM, PBF, FFM, WC, HC, WHR);adverse event, physical examination, lab test, electrocardiogram, vital sign