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Trial record 2 of 3 for:    germanium

Evaluate the Clinical Efficacy of Precious Metal Fiber Textile (Germanium Titanium π Element) for Erectile Dysfunction

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03359265
First Posted: December 1, 2017
Last Update Posted: December 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Juin-Hong Cherng, National Defense Medical Center, Taiwan
  Purpose
Erectile dysfunction (ED) is common, and is defined as "persistent or regular inability to achieve or maintain penis erection for satisfactory intercourse." Approximately 3% to 71% of males have this problem as they age, and it is predicted that 320 million males worldwide will have ED by 2025. However, sex remains a topic that is too sensitive for most people to discuss openly. With advances in the sciences, medicine, and related studies, almost 95% of ED cases are treatable. ED therapies include oral medication, vacuum erection devices, intracavernosal injection, testosterone supplementation, surgery, and psychological counseling. In addition, germanium (Ge), titanium (Ti), and π elements are noble metals that can be used to produce far-infrared radiation, and are widely used to promote blood circulation. There has been little application of these metals to treatment of ED, but their use is worth investigating. This clinical trial recruited 30 subjects (a test group of 20 and control group of 10). Cellulosic textiles, incorporating noble metals (Ge, Ti, and π elements), developed by Green Energy Nano Technology Co., Ltd, were used in the test group, while commercially available regular textiles were used in the control group. In this clinical trial, the efficacy of the test products (improvement in ED) was assessed using questionnaires. Erectile function was assessed using the International Index of Erectile Function (IIEF-5) and the validated Portuguese version of the Quality of Erection Questionnaire (QEQ); premature ejaculation was assessed using the Premature Ejaculation Diagnostic Tool (PEDT); prostate symptoms were assessed using the International Prostate Symptom Score (IPSS). The questionnaires were completed once a month and followed up for 3 months. The incidence of severe adverse effects was analyzed to assess product safety.

Condition Intervention
Erectile Dysfunction Device: underpants

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Device Feasibility
Official Title: Evaluate the Clinical Efficacy of Precious Metal Fiber Textile (Germanium Titanium π Element) for Erectile Dysfunction

Resource links provided by NLM:


Further study details as provided by Juin-Hong Cherng, National Defense Medical Center, Taiwan:

Primary Outcome Measures:
  • The International Index of Erectile Function (IIEF-5) [ Time Frame: 3 months ]

    IIEF-5 scoring:

    The IIEF-5 score is the sum of the ordinal responses to the 5 items. 22-25: No erectile dysfunction 17-21: Mild erectile dysfunction 12-16: Mild to moderate erectile dysfunction 8-11: Moderate erectile dysfunction 5-7: Severe erectile dysfunction


  • Quality of Erection Questionnaire (QEQ) [ Time Frame: 3 months ]

    The QEQ is to be evaluated as a total score, which is the sum of responses to all items transformed onto a 5-30 scale.

    The maximum score on the QEQ is 30, and a higher score indicates better function.



Enrollment: 13
Actual Study Start Date: November 24, 2015
Study Completion Date: December 31, 2016
Primary Completion Date: March 15, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Test
The test group used underpants made of precious metal fibers (germanium, titanium and phosphorus), developed by Green Energy Nano Technology Co., Ltd.
Device: underpants
Placebo Comparator: Control
The control group used commercially available underpants.
Device: underpants

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The subject or legal representative has understood the contents of this experiment and has agreed to sign the participation consent form.
  2. The subject is aged between 40 and 70 years.
  3. The patient has a medical history of erectile dysfunction for at least three months, based on a physician's diagnosis.
  4. The subject has a regular sex partner during the experimental period.

Exclusion Criteria:

  1. Subject was administered oral medication (Sildenafil, Vardenafil, or Tadalafil), vacuum suction device, or corpus cavernosum injections, seven days before the experiment commenced.
  2. Long-term use of antihypertensive medication (doxazosin or nitrate), antidepressants, sedatives, anti-androgens, or medications such as cimetidine for digestive ulcers.
  3. Severe damage to the central nervous system (including stroke or spinal injury) within the last six months.
  4. Patients with erectile dysfunction induced by non-vascular causes, such as neurological factors, hormonal factors, or related trauma.
  5. Patients with vascular sclerosis.
  6. Patients with psychogenic erectile dysfunction.
  7. Patients who had undergone radical prostatectomy or transurethral resection of the prostate.
  8. HIV patients or patients with severe liver dysfunction (GOT, GPT ≥100 IU/L).
  9. Patients with genital malformations or diseases that require sexual abstinence.
  10. Sex partner is pregnant or nursing.
  11. Patients with Peyronie's Disease.
  12. Heavy drinkers or smokers.
  13. Patients with malignant tumors or prostate cancer.
  14. Patients who had surgery during the study period that could affect the experimental results.
  15. Subjects who had a serious clinical or mental condition that could affect the experimental procedure or evaluation.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Publications:
Responsible Party: Juin-Hong Cherng, Assistant Professor, National Defense Medical Center, Taiwan
ClinicalTrials.gov Identifier: NCT03359265     History of Changes
Other Study ID Numbers: GREEN888
First Submitted: November 17, 2017
First Posted: December 1, 2017
Last Update Posted: December 1, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders