drugset / Trial / NCT03057899

Efficacy of Fenugreek Seed and Lespedeza Cuneata in TDS

NCT03057899 ↗

Phase 4 Completed 88 enrolled Pusan National University Hospital
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2015-06
Primary completion
2015-11
Completion
2015-12

Drugs

EvaluationDrugModalityDoseRoute
Subject mixed extract of fenugreek seed and Lespedeza cuneata (TFG) Traditional medicine (herbal / TCM) 200 mg —

Indications