An open-label, single-arm, single-center, Phase 3 clinical study to evaluate the safety and efficacy of Vaji Amrit Vati in subjects with Vajikara, Rasayan (Erectile Dysfunction).
概览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Kudos Laboratories India
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Mean change in International Index of Erectile Function (IIEF-15) total score from Baseline (Day 0) to End of Study (Day 14 ± 2 days). The IIEF-15 is a validated tool measuring erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction.
概览
简要总结
This Phase III, open-label, single-arm, single-center clinical study aims to evaluate the safety and efficacy of VajiAmritVati in adult males with mild-to-moderate erectile dysfunction. The primary objective is to assess improvement in erectile function using the International Index of Erectile Function (IIEF-15) over 14 days of treatment. Secondary objectives include evaluation of erection hardness, libido, sexual activity frequency, satisfaction, stamina, and safety profile.
The study will provide clinical evidence to support the traditional Ayurvedic use of VajiAmritVati and generate data necessary for future larger randomized controlled trials, contributing to the scientific validation and integration of Ayurvedic therapies in managing erectile dysfunction.
Result
A total of 30 subjects were enrolled in the study, of which 27 completed the 14-day treatment period. The study showed a significant improvement in erectile function, with IIEF-15 scores increasing across all domains, including erection frequency, rigidity, penetration ability, maintenance of erection, orgasmic function, sexual desire, and overall satisfaction. The Erection Hardness Scale improved from a mean of 1.36 at baseline to 3.06 at Day 14, indicating erections adequate for penetration. Patient-reported outcomes showed marked improvements in libido, stamina, frequency of sexual activity, arousal, and partner satisfaction. Both Investigator and Patient Global Impression of Change reflected clear improvement from baseline. Quality-of-life scores in psychological and sexual relationship domains also improved significantly. No serious adverse events were reported, and only mild, transient events occurred. Overall, Vaji Amrit Vati demonstrated strong efficacy and good tolerability within the 14-day treatment period.
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
- 25.00 Year(s) 至 65.00 Year(s)（—）
入选标准
- •1.Gender or Age- Male participants aged 25 to 65 years.
- •2.Diagnosis: Clinically established mild-to-moderate erectile dysfunction, confirmed by investigator assessment and an IIEF-15 total score between 11 and 25 (inclusive) at baseline.
- •3.Relationship Status: Living with or having a regular sexual partner willing to cooperate with study assessments.
- •4.Health Status: o Medically stable, judged suitable for participation based on medical history and physical examination.
- •o Able and willing to abstain from any other sexual-enhancement medications or supplements during the study.
- •5.Consent: Capable of understanding study procedures and providing written informed consent prior to participation.
- •6.Compliance: Willing and able to comply with study requirements, including diary completion and visit attendance.
排除标准
- •Severe erectile dysfunction with IIEF score less than 10, showing complete inability to achieve or maintain an erection sufficient for penetration.
- •History of secondary sexual disorders such as premature ejaculation, decreased libido of psychogenic origin, or other diagnosed sexual disorders.
- •Presence of major medical conditions including:
- •Uncontrolled hypertension with blood pressure equal to or above 160 by 100 mmHg, diabetes mellitus with HbA1c more than 8.5, severe dyslipidemia, hepatic or renal impairment.
- •Recent myocardial infarction, stroke, or major cardiovascular event within the last six months.
- •Known endocrine or neurological disease affecting sexual function.
- •History of surgical or anatomical causes such as radical prostatectomy, pelvic surgery, or pelvic radiotherapy.
- •Use of drugs or substances that may interfere with study outcomes including:
- •Use of PDE5 inhibitors, testosterone therapy, or other erectile dysfunction drugs within two weeks prior to baseline.
- •Current use of antidepressants, antipsychotics, opioids, or other medications known to impair sexual function.
结局指标
主要结局
Mean change in International Index of Erectile Function (IIEF-15) total score from Baseline (Day 0) to End of Study (Day 14 ± 2 days). The IIEF-15 is a validated tool measuring erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction.
时间窗: Day 0, Day 7 ± 2, Day 14 ± 2
次要结局
- 1. Change in Erection Hardness Scale (EHS) score from Baseline to Day 14 ± 2 days.(2. Changes in libido, frequency of sexual activity, sexual satisfaction, and stamina assessed via patient-reported outcome questionnaires at Day 0, Day 7 ± 2 days, and Day 14 ± 2 days.)
研究者
Dr Sambashiva
Samahitha Research Solutions