Clinical study of comprehensive TCM therapy in the treatment of damp and hot stasis erectile dysfunction

The dilemma of male sexual dysfunction has been the focus of the whole society. Erectile dysfunction (ED) is one of the common sexual dysfunctions, and traditional Chinese medicine therapy has shown potential benefits in the treatment of ED. Comprehensive therapy of traditional Chinese medicine (CTTCM) is a comprehensive application of Chinese medicine therapy for auxiliary intervention. Through preliminary clinical observations, we found that CTTCM is simple, safe, and has good efficacy; however, there is a lack of rigorous clinical trials to support its application. Therefore, we designed a randomized controlled trial to evaluate the efficacy and safety of CTTCM for patients with ED of damp-heat stasis type, and to provide evidence for the clinical application of CTTCM and the construction of a traditional Chinese medicine andrology rehabilitation system. METHODS: In this randomized controlled study, 108 eligible patients were assigned 1:1 to the CTTCM group or the tadalafil group. The treatment period was 8 weeks and the follow-up period was 8 weeks. The primary outcome will be the International Erectile Function Score and traditional Chinese medicine Syndrome Score. Secondary outcomes will include the Erection Quality Score, Patient Health Questionnaire-9, and the 7-item Generalized Anxiety Scale. Safety results will include electrocardiogram, blood tests (including blood, liver and kidney function), urine and stool. International Erectile Function Score-5, traditional Chinese medicine Syndrome Score, Erectile Quality Score, Patient Health Questionnaire-9, 7-item Generalized Anxiety Scale and all Safety outcomes will be conducted at baseline, 2th, 4th, 6(th), and 8th week. Follow-up results will be assessed at 8th week after 8 weeks’ treatment. DISCUSSION: This study will provide preliminary evidence for the efficacy and safety of traditional Chinese medicine integrated therapy in the treatment of damp-heat stasis ED. In addition, it also provides a basis for the clinical application of Chinese medicine comprehensive therapy and the construction of Chinese medicine andrology rehabilitation system. TRIAL REGISTRATION: Chinese clinical trial registration identifier, ChiCTR2200062016, registered on July 19, 2022.