Erectile Dysfunction
Conditions
Interventions
Control group:Tadalafil tablets 5 mg/dose, once daily, orally, for 4 consecutive weeks
Warm acupuncture group:Warm acupuncture (moxibustion on the needle): Two groups of acupoints were used alternately with bilateral needling. Group 1: Qihai (CV6), Guanyuan (CV4), Zhongji (CV3), Dahe (
Warm acupuncture + Medication group:Warm acupuncture is administered in combination with oral tadalafil.
Sponsors
Guangdong Provincial Hospital of Traditional Chinese Medicine Hai Nan Hospital
Eligibility
Sex/Gender
Male
Age
20 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1.Meeting the diagnostic criteria for erectile dysfunction (Western medicine) with a disease duration = 3 months, and TCM syndrome differentiation as kidney deficiency and blood stasis (manifested as inability to attain or maintain erection, weak erection, decreased libido, accompanied by soreness and weakness of the lower back and knees, fatigue, stabbing pain in the lower abdomen or scrotum, etc.); 2.International Index of Erectile Function-5 (IIEF-5) score of 8–21, indicating mild-to-moderate erectile dysfunction; 3.Male patients aged 20–60 years, with a stable sexual partner and regular sexual activity during the study period; 4.No use of medications affecting erectile function within the past 4 weeks (such as PDE5 inhibitors, TCM aphrodisiac preparations, hormonal drugs, etc.); 5.Absence of severe cardiovascular or cerebrovascular diseases, hepatic or renal insufficiency, bleeding tendency, or infectious diseases, and no contraindications to acupuncture; 6.Voluntary participation in this study and signing of written informed consent
Exclusion criteria
Exclusion criteria: 1.Erectile dysfunction (ED) caused by organic lesions (e.g., severe vascular disease, nerve injury, anatomical abnormalities of the penis, etc.). 2.Concomitant severe cardiovascular and cerebrovascular diseases (e.g., unstable angina, recent myocardial infarction, severe arrhythmia, uncontrolled hypertension), hepatic or renal insufficiency (ALT/AST > 2 × upper limit of normal [ULN], Cr > ULN), endocrine diseases (e.g., hypogonadism, hyperprolactinemia), hematological diseases, or mental disorders (e.g., schizophrenia, major depressive disorder). 3.Allergy to the study drug (tadalafil) or any of its excipients. 4.Bleeding tendency or current use of anticoagulant medications (e.g., warfarin, aspirin) that may compromise the safety of acupuncture procedures. 5.Local skin infection, ulcer, scar, or tumor at the intended acupuncture points. 6.Participation in another clinical trial of a drug or medical device within the past 3 months. 7.Partner unable to cooperate (e.g., partner with a severe physical or mental illness, or who does not consent to participate in the study). 8.History of drug addiction or substance abuse. 9.Poor compliance as judged by the investigator, making it unlikely to complete the study protocol requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| International Index of Erectile Function-5 (IIEF-5) score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Erectile Hardness Score (EHS);Hamilton Anxiety Rating Scale (HAMA);Hamilton Depression Rating Scale 6-item version (HAMD-6);Traditional Chinese Medicine (TCM) Syndrome Score;Self-Esteem and Relationship Questionnaire;Serum sex hormone indicators;Penile blood flow ultrasound examination;Penile tip vibration perception threshold; | — |
Countries
China
Contacts
Public ContactFeng Qifan
Guangdong Provincial Hospital of Traditional Chinese Medicine Hai Nan Hospital
Outcome results
None listed