Efficacy of Fenugreek Seed and Lespedeza Cuneata in TDS

NCT03057899 | Completed Phase 4

• 1 other identifier: Fenugreek for TDS
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypogonadism

Keywords

Herbal medicine; phytotherapy; testosterone

Outcome Measures

Primary Outcomes (6)

• Aging Males' Symptoms (AMS) scale

  4 week

• level of serum total testosterone

  4 week

• level of serum free testosterone

  4 week

• Aging Males' Symptoms (AMS) scale

  8 week

• level of serum total testosterone

  8 week

• level of serum free testosterone

  8week

Secondary Outcomes (7)

• percentage of positivity on the Androgen Deficiency in Aging Males (ADAM) questionnaire

  8 week

• level of serum total cholesterol

  8 week

• level of serum HDL-C

  8 week

• level of serum LDL-C

  8 week

• level of serum triglyceride

  8 week

Study Arms (2)

fenugreek seed and Lespedeza cuneata (TFG)

EXPERIMENTAL

Patients who received investigational products (200 mg TFG) twice per day for 8 weeks at least 30 minutes after food intake

Drug: TFG capsules (200 mg /capsule)

Placebo

PLACEBO COMPARATOR

Patients who received placebo twice per day for 8 weeks at least 30 minutes after food intake

Drug: Placebo oral capsule

Interventions

TFG capsules (200 mg /capsule) DRUG

TFG capsules were prepared using extracts from Trigonella foenum-graecum seed and Lespedeza cuneata. During the study period, two capsules were taken daily for 8 weeks.

Also known as: mixed extract of fenugreek seed and Lespedeza cuneata (TFG)

fenugreek seed and Lespedeza cuneata (TFG)

Placebo oral capsule DRUG

During the study period, two capsules were taken daily for 8 weeks. Placebo and TFG capsules were identical in shape, color, and taste.

Also known as: Placebo capsule

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• total scores on the Aging Males' Symptoms scale (AMS) questionnaire ≥ 27; total serum cholesterol \<220 mg/dl; and triglyceride 150-399 mg/dl

You may not qualify if:

• diagnosis of another sexual disorder, serum creatinine \> 2.5 mg/dL, an uncontrolled psychiatric disorder, history of major hematological, renal, or hepatic abnormalities, body mass index ≥ 45 kg/m2, HBsAg (hepatitis B surface antigen) positive, prostate specific antigen (PSA) ≥ 4.0 ng/ml, cardiac failure, or a history of alcoholism or substance abuse. Patients who had taken PDE5 inhibitors, TRT, anti-androgen, statins, fibrates, niacin, steroid, fish oil, colestin, fiber-based laxatives, phytosterol margarines, anti-diabetics, anti-platelet, thyroxine, diuretics, or beta-blockers were also excluded.

Sponsors & Collaborators

• Pusan National University Hospital: lead

Study Sites (1)

Department of Urology, Pusan National University Hospital

Busan, 602-739, South Korea

Location

MeSH Terms

Conditions

Hypogonadism

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 11, 2017
• First Posted: February 20, 2017
• Study Start: June 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 20, 2017

Record last verified: 2017-02

Locations

KR (1)