Clinical trial to evaluate the effect of advanced formulation for Lepidium meyenii on late-onset hypogonadism

The improvement effect of advanced formulation(Tablet, 5g/day) for Lepidium myenii on late-onset hypogonadism : randomized, double-blind, placebo-controlled, parallel group

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0006415

Enrollment

Registered

2021-08-03

Start date

2020-08-31

Completion date

Unknown

Last updated

2021-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Dietary Supplement : maca gelatinized powder or placebo capsule 1000mg, oral intake of 2 capsules at a time, three times per day before food intake for 12 weeks

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. men aged over 40 years 2. complaining of symptoms related to late onset hypogonadism with total scores on the Aging Males’ Symptoms scale (AMS) questionnaire =27

Exclusion criteria

Exclusion criteria: 1. Subjects who had taken testosterone replacement therapy (TRT) within 6 months before randomization 2. Total serum Testosterone < 2.0 ng/mL 3. Subject who has taken PDE5 inhibitor 4. history or diagnosis of prostate cancer 5. prostate specific antigen =4.0ng/mL 6. severe obstructive sleep apnea 7.

Design outcomes

Primary

Measure	Time frame
The change of Aging males' symptoms Korean version (AMS) score from baseline	—

Secondary

Measure	Time frame
The change of International Index of Erectile Function (IIEF-5) score from baseline;The change of Androgen Deficiency in Aging Males (ADAM) score from baseline;The change of International Prostate Symptom Score (IPSS) from baseline	—

Countries

Korea, Republic of

Contacts

Public ContactWoongJin Bae

The Catholic University of Korea, Seoul St. Mary's Hospital

bwoong@catholic.ac.kr+82-2-2258-6345

Outcome results