ITMCTR2100004505招募中1 期
A randomized, double-blind, placebo-controlled, multicenter clinical study on the efficacy and safety of hongjing-1 in the treatment of impotence
The Second Affiliated Hospital of Zhejiang University of Traditional Chinese Medicine0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 性别
- Male
入选标准
- •1. Patients who meet the diagnostic criteria of impotence in traditional Chinese medicine: impotence refers to the disease that adult men can't have normal sexual life due to impotence of penis when they have sex. The course of disease is more than 3 months (refer to the standard T / CACM 2015-bz076 of Chinese society of traditional Chinese Medicine);
- •2. Qi deficiency (refer to the national standard GB / 16751.2-1997 terminology for clinical diagnosis and treatment of traditional Chinese medicine issued by the State Bureau of technical supervision);
- •Main symptoms: shortness of breath, fatigue, mental weakness, pulse deficiency;
- •Secondary symptoms: spontaneous sweating, lazy speech, weak tongue;
- •Qi deficiency can be diagnosed with two main symptoms and one secondary symptom;
- •Blood stasis (refer to the national standard GB / 16751.2-1997 terminology for clinical diagnosis and treatment of traditional Chinese medicine issued by the State Bureau of technical supervision);
- •Main symptoms: tingling, pain with fixed place, refusal to press, blood stasis in veins (such as dark purple on lips, gums and claws, red streaks on skin surface, or exposed green tendons in abdomen), subcutaneous ecchymosis, blood from menstruation, dark purple tongue with ecchymosis or ecchymosis, thick tongue pulse, astringent pulse, no pulse or deep pulse, late pulse;
- •Secondary symptoms: skin nail error, limb numbness or hemiplegia, mania, forgetfulness, local paresthesia, history of trauma and surgery;
- •Blood stasis can be diagnosed by two main symptoms, one main symptom and two secondary symptoms;
- •TCM syndrome diagnosis of qi deficiency and blood stasis includes the above diagnosis of qi deficiency and blood stasis.
- •3. Patients older than 22 and younger than 65 years;
- •4. For patients with mild to moderate ed, the IIEF-5 score of visit 1 was more than 7 and less than 21;
- •5. Patients with fixed heterosexual relationship for more than 3 months;
- •6. Patients who agreed to have at least 4 sexual intercourse attempts every 4 weeks during the trial period;
- •7. For patients who had at least 4 sexual intercourse attempts during the induction period, the iief-ef score of visit 2 was 11-25 points (17-25 points were mild, 11-16 points were moderate, and <= 10 points were severe);
- •8. Patients who voluntarily participated in the trial and obtained informed consent.
排除标准
- •1. Patients with poorly controlled diabetes mellitus (fasting blood glucose > 120% upper limit of normal value);
- •2. Those patients with impotence due to spinal cord / nerve injury or radical prostatectomy;
- •3. Patients with persistent penile erection or abnormal penile anatomical structure (such as angular deformity, cavernous fibrosis or penile induration) or prone to abnormal penile erection (such as sickle cell anemia, multiple myeloma or leukemia);
- •4. Patients using penile prosthesis;
- •5. Patients with serious psychological abnormalities and not well controlled;
- •6. Patients with endocrine diseases such as hypogonadism, hypothyroidism and hypopituitarism;
- •7. Patients with hypogonadism who are undergoing androgen replacement therapy but have not received stable treatment for more than 3 months;
- •8. Patients with myocardial infarction, stroke, life-threatening arrhythmia or potential cardiovascular risk during sexual behavior within 6 months before enrollment, including but not limited to obvious abnormal ECG judged by researchers, history of coronary artery reconstruction, unstable angina pectoris, angina pectoris during sexual intercourse, congestive heart failure, significant cardiomyopathy, moderate or severe cardiovascular disease, etc.;
- •9. Patients with aspartate aminotransferase AST and alanine aminotransferase ALT more than twice the upper limit of normal value; patients with creatinine more than twice the upper limit of normal value.;
- •10. Patients with hemorrhagic disease or active peptic ulcer.;
- •11. Patients with resting hypotension (blood pressure below 90/50 mmHg) or poorly controlled hypertension (blood pressure higher than 170 / 100mmhg);
- •12. Patients with alcohol abuse in the past 6 months (drinking more than 14 alcohol units per week; 1 alcohol unit for a bottle of 350 ml beer, 120 ml wine or 30 ml 40% alcohol) and drug abuse.
- •13. Unable to cooperate to complete the subject records required in the trial.
- •14. Patients with obvious concurrent syndrome or combined syndrome.
- •15. Those patients with allergic constitution and allergic to a variety of drugs.
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