A Multicentric, Single-Arm Open-label Clinical Study to Evaluate the Efficacy and Safety of X-TendPower Capsule for Low Libido and/or Erectile Dysfunction in Patients with a History of Smoking, Early-Onset Type 2 Diabetes Mellitus, and Psychological Stress.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Improvement in libido and/or erectile function assessed by the International Index of Erectile Function (IIEF-15) questionnaire.
研究概览
简要总结
Erectile dysfunction (ED) and low libido are prevalent sexual health disorders, particularly in men exposed to metabolic and lifestyle risk factors such as chronic smoking, early-onset type 2 diabetes mellitus (T2DM), and psychological stress. These interconnected conditions contribute to vascular dysfunction, hormonal imbalance, and neuroendocrine dysregulation, leading to impaired erectile function and diminished sexual desire.
Modern pharmacotherapies, such as PDE5 inhibitors, offer limited relief in these populations, especially when psychological, hormonal, and metabolic pathways are simultaneously compromised. This underlines the need for a multi-targeted, holistic intervention that is effective, safe, and well-tolerated in long-term use.
The proposed clinical trial investigates a herbo-nutraceutical formulation containing traditional Ayurvedic ingredients—Ashwagandha, Guduchi, Kaunch, Mustaka, Gokshura, and Shilajit—all of which have shown promising evidence in improving sexual function, stress resilience, endocrine modulation, and metabolic support.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 30.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- Male
入选标准
- •Male participants aged 30 to 55 years.
- •History of low libido and/or erectile dysfunction (diagnosed or self-reported, greater than or equal to 3 months), as defined by an International Index of Erectile Function (IIEF-15) score less than or equal to
- •History of smoking (current or former smokers with at least 1–5 cigarettes per day).
- •Diagnosed with early-onset Type 2 Diabetes Mellitus (diagnosis before the age of 45, with current HbA1c between 6.5 percentage and 8.5 percentage) within the last 6 months.
- •Moderate to high perceived stress, defined by a score greater than or equal to 14 on the Perceived Stress Scale (PSS-10).
- •Willing and able to provide written informed consent.
- •Willing to comply with all study-related procedures and assessments for the full duration of the study.
- •Stable dose of ongoing medications for Chronic ailments (e.g., antidiabetic, antihypertensive) for the past 3 months.
排除标准
- •Severe ED due to anatomical or neurological causes (e.g., spinal cord injury, post-prostatectomy).
- •Use of PDE-5 inhibitors or other ED medications in the past 4 weeks.
- •Uncontrolled T2DM (HbA1c greater than 8.5 percentage) or recently initiated antidiabetic therapy (within 3 months).
- •History of myocardial infarction, stroke, or unstable angina within the last 6 months.
- •Hypogonadism or androgen deficiency, defined by serum testosterone less than 200 ng/dL.
- •Psychiatric disorders (e.g., severe depression, psychosis) requiring medication.
- •Known hepatic or renal impairment (ALT or AST greater than 2.5× ULN, eGFR less than 60 mL/min).
- •Any active malignancy or treatment for cancer within the last 12 months.
- •Known allergy or hypersensitivity to any component of the supplement capsule.
- •Participation in another investigational study within the past 30 days.
结局指标
主要结局
Improvement in libido and/or erectile function assessed by the International Index of Erectile Function (IIEF-15) questionnaire.
时间窗: From baseline to end of study (90 Days).
次要结局
- Changes in nitric oxide levels (pre- and post-intervention)(Changes in nitric oxide levels (pre- and post-intervention):)
- Changes in serum TNF-alpha and IL-6 levels (inflammatory biomarkers)(Changes in inflammatory biomarkers:)
- Changes in perceived stress levels assessed by the Perceived Stress Scale (PSS).(Changes in perceived stress levels assessed by the Perceived Stress Scale (PSS):)
- Changes in serum testosterone levels (total and free)(Changes in serum testosterone levels (total and free):)
- Safety evaluated via adverse event monitoring and laboratory assessments(Safety Endpoints:)
研究者
Dr Sandeep Kumar Gupta
MV Hospital and Research Centre