Daily Oral L-arginine Plus Tadalafil in Diabetic Patients With Erectile Dysfunction: A Double-blinded Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Increase in Serum Total testosterone level in (nmol/L) after treatment.
研究概览
简要总结
Tadalafil is an effective oral therapy in erectile dysfunction. L-arginine is a pro drug that increase the level of nitrous oxide in the smooth muscles so can increase the strength and duration of erection. this clinical trials compare the daily oral L-arginine plus tadalafil in treatment of erectile dysfunction in diabetic patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 56 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •patients with type 2 DM
排除标准
- •Patients with history of pelvic trauma, major pelvic surgical intervention, hypogonadism, hyperprolactinemia, hypertension, chronic prostatitis, chronic liver disease, smokers, history of chronic intake of CNS or anti-androgen drugs and patients with Peyronie's Disease or any fibrotic anomalies
研究组 & 干预措施
Group A
receive L-arginine 5 g oral caps daily for 8 weeks serum testosterone level measurement penile doppler
干预措施: L-arginine 5 gm oral caps (Drug)
Group A
receive L-arginine 5 g oral caps daily for 8 weeks serum testosterone level measurement penile doppler
干预措施: serum testosterone level (Diagnostic Test)
Group A
receive L-arginine 5 g oral caps daily for 8 weeks serum testosterone level measurement penile doppler
干预措施: HbA1C (Diagnostic Test)
Group A
receive L-arginine 5 g oral caps daily for 8 weeks serum testosterone level measurement penile doppler
干预措施: penile doppler (Device)
Group B
receive tadalafil 10 mg oral tablets daily for 8 weeks serum testosterone level measurement penile doppler
干预措施: Tadalafil 10 MG (Drug)
Group B
receive tadalafil 10 mg oral tablets daily for 8 weeks serum testosterone level measurement penile doppler
干预措施: serum testosterone level (Diagnostic Test)
Group B
receive tadalafil 10 mg oral tablets daily for 8 weeks serum testosterone level measurement penile doppler
干预措施: HbA1C (Diagnostic Test)
Group B
receive tadalafil 10 mg oral tablets daily for 8 weeks serum testosterone level measurement penile doppler
干预措施: penile doppler (Device)
Group C
receive L-arginine 5 g oral caps plus tadalafil 10 mg oral tablets daily for 8 weeks serum testosterone level measurement penile doppler
干预措施: L-arginine 5 gm oral caps (Drug)
Group C
receive L-arginine 5 g oral caps plus tadalafil 10 mg oral tablets daily for 8 weeks serum testosterone level measurement penile doppler
干预措施: Tadalafil 10 MG (Drug)
Group C
receive L-arginine 5 g oral caps plus tadalafil 10 mg oral tablets daily for 8 weeks serum testosterone level measurement penile doppler
干预措施: serum testosterone level (Diagnostic Test)
Group C
receive L-arginine 5 g oral caps plus tadalafil 10 mg oral tablets daily for 8 weeks serum testosterone level measurement penile doppler
干预措施: HbA1C (Diagnostic Test)
Group C
receive L-arginine 5 g oral caps plus tadalafil 10 mg oral tablets daily for 8 weeks serum testosterone level measurement penile doppler
干预措施: penile doppler (Device)
Group D
receive oral methyl cellulose daily for 8 weeks serum testosterone level measurement penile doppler
干预措施: serum testosterone level (Diagnostic Test)
Group D
receive oral methyl cellulose daily for 8 weeks serum testosterone level measurement penile doppler
干预措施: HbA1C (Diagnostic Test)
Group D
receive oral methyl cellulose daily for 8 weeks serum testosterone level measurement penile doppler
干预措施: penile doppler (Device)
结局指标
主要结局
Increase in Serum Total testosterone level in (nmol/L) after treatment.
时间窗: 8 weeks of treatment
Measurement of total testosterone level in (nmol/L) improvement after treatment
Improvement in Penile Doppler parameters after treatment including peak systolic velocity in (cm/sec), end diastolic volume in (cm/sec) and resistive index (RI) that = (peak systolic velocity - end diastolic velocity ) / peak systolic velocity.
时间窗: 8 weeks of treatment
Measurement of penile doppler parameters improvement after treatment peak systolic velocity in (cm/sec), end diastolic volume in (cm/sec) and resistive index (RI).
International Index of Erectile Function score (IIEF-5) improvement after treatment. IIEF-5 score of 22-25: No erectile dysfunction (ED), 17-21: Mild ED, 12-16: Mild to moderate ED, 8-11: Moderate ED, 5-7: Severe ED.
时间窗: 8 weeks of treatment
Efficacy of oral L-arginine 5 g plus oral tadalafil 10 mg in treatment of erectile dysfunction in diabetic patients is evaluated by International Index of Erectile Function score (IIEF-5).
次要结局
未报告次要终点
研究者
Moustafa A. El Taieb
Ass. Prof. of Dermatology, Venereology and Andrology
Aswan University Hospital