Male sexual dysfunction with depressive states
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Meet Western diagnostic criteria for erectile dysfunction and/or premature ejaculation 2.Meet the TCM diagnostic and differentiation criteria for erectile dysfunction and/or premature ejaculation 3.18 points= Screening Period Hamilton Depression Scale-17 (HAMD-17)=24 points 4.Age 18~50 years old (including 18 and 50 years old) 5.Voluntarily sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1.Patients with severe cardiopulmonary dysfunction, as well as serious primary diseases of other systems such as heart, liver, and kidney 2.premature ejaculation or erectile dysfunction caused by a history of substance abuse 3.inflammation of the reproductive system, urinary stones, excessive foreskin, dysfunction of sexual partners 4.external genital hypoplasia or history of trauma or surgery 5.Those who have taken antidepressants, anxiolytics or other psychotropic drugs in the past 4 weeks or are currently taking, or in-hospital preparations, proprietary Chinese medicines or decoctions with similar effects 6.Those who have participated in clinical trials of other drugs in the past three months 7.The investigators believe that others are not suitable to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change from baseline in the total score of the HAMD-17 over 8 wees of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| The change from baseline in the total score of the HAMD-17 over 4 wees of treatment;The change in the Hamilton Anxiety Scale (HAMA) total score from baseline;Change in total erectile function index (IIEF-5) score from baseline;Change in the total score of the Premature Ejaculation Diagnostic Tool Scale (PEDT) from baseline;Change in the total score of the Health Questionnaire (SF-36) from baseline; | — |
Countries
China
Contacts
Dongzhimen Hospital of Beijing University of Traditional Chinese Medicine