ITMCTR2024000095尚未招募Unknown
Efficacy of Hong jing qi wei formula for the treatment of type 2 diabetes mellitus erectile dysfunction: a randomized, controlled trail
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 22 至 65（—）
- 性别
- Male
入选标准
- •(1) Meet the western medical diagnostic criteria for type 2 diabetes mellitus and ED, and type 2 diabetes mellitus occurs before the diagnosis of ED;
- •(2) Meet the TCM diagnostic criteria of kidney deficiency and blood stasis syndrome;
- •(3) Age: 22 = age = 65 years old;
- •(4)Glycosylated hemoglobin <7%;
- •(5)IIEF-5 score =21;
- •(6) have a regular sexual partner and stable sex life, and still expect to maintain an active sex life with the sexual partner during the study period, at least 1 time per week;
- •(7) Voluntarily participate in the study and sign the informed consent form.
排除标准
- •(1) People with severe psychosomatic factors or history of psychiatric disorders, or those with SAS > 69 or SDS > 72 or those who are unable to guarantee that they will stop using anti-anxiety or depression medication during the trial period;
- •(2) Clinically significant penile anatomical or structural abnormalities (including but not limited to) as determined by the investigator: e.g., small penis, congenital curvature of the penis, penile cavernous fibrosis;
- •(3) Patients with this disease due to other sexual dysfunction disorders (e.g., ejaculatory disorders, premature ejaculation) or incurable endocrine disorders (e.g., hypogonadism, hyperprolactinemia, hyper/hypothyroidism, Cushing's disease, or hypopituitarism, etc.);
- •(4) Erectile dysfunction due to spinal cord/nerve injury or radical prostate cancer or other trauma, surgery, or radiation therapy;
- •(5) A history of one of the following cardiac conditions
- •a Myocardial infarction, shock, or life-threatening arrhythmia within the last 6 months;
- •b Unstable angina pectoris within the last 3 months or previous angina pectoris during sexual intercourse;
- •c Coronary artery bypass grafting within the last 3 months, or percutaneous coronary intervention;
- •d New York Heart Association (NYHA) = Class II heart failure within the past 6 months;
- •(6) Significant hepatic or renal dysfunction (liver function ALT and/or AST greater than 1.5 times the upper limit of normal, or creatinine greater than 20% of the upper limit of normal);
- •(7) History of severe central nervous system injury (cerebrovascular disease such as cerebral ischemia or hemorrhage, inflammatory brain disease such as encephalitis or meningitis, craniocerebral trauma or spinal cord injury) or peripheral muscular neurological disease within the past 6 months;
- •(8) Known to have abnormal color vision, pigmentary retinitis, macular degeneration, non-arteritic anterior ischemic optic neuropathy ocular diseases;
- •(9) Persons with a history of malignant tumors;
- •(10) Persons with a known prior history of sudden hearing loss or hearing loss;
- •(11) Penile prosthesis installers;
- •(12) Those who are allergic to PDE5i drugs, or whose treatment for erectile dysfunction is ineffective or who have had adverse reactions that led to the discontinuation of the drug;
- •(13) Those who are currently using the drug regularly (for more than 1 month) and are unable to stop the use of nitrates or NO donors, anti-androgens, guanylate cyclase agonists, or other drugs or treatments for erectile dysfunction during the study period;
- •(14) The patient's sexual partner is breastfeeding or pregnant or preparing for pregnancy, or is undergoing treatment for a gynecological condition that restricts sexual activity;
- •(15) Participation in other trials in the last 3 months.
研究者
相似试验
招募中
4 期
Clinical efficacy evaluation of Huoxiang Zhengqi water in the treatment of children's spleen and stomach diseases by percutaneous (navel) administration -- an observational studySpleen and stomach diseases in childrenITMCTR2200006436Jiangxi University of Traditional Chinese Medicine
招募中
不适用
Clinical Efficacy Observation of Yiqi Huoxue Prescription in Treating Coronary Heart Disease with Qi Deficiency and Blood Stasis Syndrome After PCIITMCTR2100004215Affiliated Hospital of Chengdu University of traditional Chinese Medicine
招募中
1 期
A clinical study on the efficacy of Yiqi Huayu Jiedu decoction for reducing the risk of postoperative recurrence and metastasis of gastric cancer Protocol for a multicenter, randomized, double-blind, placebo-controlled trialgastric cancerITMCTR2100004250Department of Oncology, Jiangsu Province Hospital of Chinese Medicine
招募中
1 期
Study on the clinical efficacy of Yiqi Huoxue Jiedu formula in the treatment of platinum resistant ovarian cancer based on the phenotypic changes of macrophagesovarian cancerITMCTR2100005211Guang'anmen Hospital, Chinese Academy of traditional Chinese Medicine
尚未招募
不适用
Clinical efficacy evaluation of Shizhen formula for patients with eczema of anus of damp-heat typeeczema of anusITMCTR2200006596Shuguang Hospital Affiliated with Shanghai University of Traditional Chinese Medicine