Ignite Creation Date:
2024-05-06 @ 9:44 AM
Last Modification Date:
2024-10-26 @ 12:18 PM
Study NCT ID:
NCT03057899
Status:
COMPLETED
Last Update Posted:
2017-02-20
First Post:
2017-02-11
Brief Title:
Efficacy of Fenugreek Seed and Lespedeza Cuneata in TDS
Sponsor:
Pusan National University Hospital
Organization:
Pusan National University Hospital
Study Overview
Official Title:
Efficacy and Safety of a Mixed Extract of Fenugreek Seed and Lespedeza Cuneata in the Treatment of Testosterone Deficiency Syndrome A Randomized Double-blind Placebo-Controlled Clinical Trial
Status:
COMPLETED
Status Verified Date:
2017-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Objective The aim of this study was to investigate the efficacy and safety of a mixed extract of fenugreek seed and Lespedeza cuneata TFG for the treatment of testosterone deficiency syndrome TDS
Design Patients were instructed to take a placebo capsule or 200 mg TFG capsule twice per day for 8 weeks
Outcome measures The primary efficacy variable was the change from baseline in the Aging Males Symptoms scale AMS as well as levels of serum total testosterone and free testosterone Secondary efficacy measurements included changes from baseline in the number of yes answers on the Androgen Deficiency in the Aging Male questionnaire ADAM levels of serum total cholesterol HDL-C LDL-C triglyceride perceived stress scale PSS-10 all domain scores of the International Index of Erectile Function IIEF as well as changes in body composition
Design Patients were instructed to take a placebo capsule or 200 mg TFG capsule twice per day for 8 weeks
Outcome measures The primary efficacy variable was the change from baseline in the Aging Males Symptoms scale AMS as well as levels of serum total testosterone and free testosterone Secondary efficacy measurements included changes from baseline in the number of yes answers on the Androgen Deficiency in the Aging Male questionnaire ADAM levels of serum total cholesterol HDL-C LDL-C triglyceride perceived stress scale PSS-10 all domain scores of the International Index of Erectile Function IIEF as well as changes in body composition
Detailed Description:
Testosterone deficiency syndrome TDS is a clinical and biochemical syndrome associated with advancing age and characterized by symptoms of a deficiency in serum testosterone levels TDS can cause a significant decrease in quality of life and has many adverse effects on multiple organs in terms of mens health In addition to the detrimental effect of sexual functions men with TDS tend to have increased waist circumference hyperglycemia hypertriglyceridemia hyperlipidemia and a history of diabetes TDS can be treated with testosterone replacement therapy TRT TRT should be initiated on an individualized basis in TDS patients who have clinical signs and symptoms of androgen deficiency if the benefits of treatment appear to outweigh the potential risks and only after thorough discussion with the patient Different preparations of testosterone are currently available The majority of clinical data shows that TRT is very safe and effective There is currently no evidence that testosterone treatment increases the risk of prostate disease using modern guidelines However the fear of prostate cancer and the risk of erythrocytosis may represent the main limitations of TRT in aging men Additionally TRT cannot improve the function of Leydig cells which produce testosterone but only compensate for the lack of testosterone
Limited research has focused on the use of herbal medicine to improve male health particularly to increase testosterone levels and support healthy sexual function Despite the increasing availability of effective conventional medical treatments plant-derived and herbo-mineral remedies continue to be a popular alternative for men seeking to improve sexual function
Trigonella foenum-graecum Linn also known as fenugreek is an aromatic annual plant that reaches heights of 30-60 cm It is found wild in Kashmir Punjab and the upper Gangetic plains and is widely cultivated in many parts of India It is used internally as an abortifacient antispasmodic appetite stimulant blood cleanser laxative tonic and expectorant It is also indicated externally for abscesses boils galactagogue and for its demulcent and emollient properties The seeds contain diosgenin along with three minor steroidal saponins similagenin savsalpogenin and yuccagenin choline trimethylamine a sex hormone in frogs vitamins A B2 B6 B12 D lysine l-tryptophan rich proteins mucilaginous fiber coumarin fenugreekine nicotinic acid sapogenins phytic acid scopletin and trigonelline calcium iron β-carotene and other vitamins and essential oils
Previous studies have suggested that Trigonella foenum-graecum seed extract has positive effects on sexual health and quality of life and that it demonstrates anabolic and androgenic activity in young patients It is believed that these positive effects are due to increased testosterone including free testosterone and that Trigonella foenum-graecum seed extract may be an effective treatment for the symptoms of possible testosterone deficiency in aging men The basis for this androgenic activity may be due to the fact that Trigonella foenum-graecum seeds contain soluble steroidal saponins specifically furostanol glycosides which are responsible for complexing cholesterol in the cell membrane Other studies have found that Trigonella foenum-graecum increases testosterone and free testosterone suggesting that it may be an incomplete 5-alpha reductase and aromatase inhibitor The investigators investigated the efficacy and safety of a mixed extract of Trigonella foenum-graecum seed and lespedeza cuneata TFG for the treatment of TDS
Limited research has focused on the use of herbal medicine to improve male health particularly to increase testosterone levels and support healthy sexual function Despite the increasing availability of effective conventional medical treatments plant-derived and herbo-mineral remedies continue to be a popular alternative for men seeking to improve sexual function
Trigonella foenum-graecum Linn also known as fenugreek is an aromatic annual plant that reaches heights of 30-60 cm It is found wild in Kashmir Punjab and the upper Gangetic plains and is widely cultivated in many parts of India It is used internally as an abortifacient antispasmodic appetite stimulant blood cleanser laxative tonic and expectorant It is also indicated externally for abscesses boils galactagogue and for its demulcent and emollient properties The seeds contain diosgenin along with three minor steroidal saponins similagenin savsalpogenin and yuccagenin choline trimethylamine a sex hormone in frogs vitamins A B2 B6 B12 D lysine l-tryptophan rich proteins mucilaginous fiber coumarin fenugreekine nicotinic acid sapogenins phytic acid scopletin and trigonelline calcium iron β-carotene and other vitamins and essential oils
Previous studies have suggested that Trigonella foenum-graecum seed extract has positive effects on sexual health and quality of life and that it demonstrates anabolic and androgenic activity in young patients It is believed that these positive effects are due to increased testosterone including free testosterone and that Trigonella foenum-graecum seed extract may be an effective treatment for the symptoms of possible testosterone deficiency in aging men The basis for this androgenic activity may be due to the fact that Trigonella foenum-graecum seeds contain soluble steroidal saponins specifically furostanol glycosides which are responsible for complexing cholesterol in the cell membrane Other studies have found that Trigonella foenum-graecum increases testosterone and free testosterone suggesting that it may be an incomplete 5-alpha reductase and aromatase inhibitor The investigators investigated the efficacy and safety of a mixed extract of Trigonella foenum-graecum seed and lespedeza cuneata TFG for the treatment of TDS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None