An open lable single arm clinical study on the effectiveness of Akarakarabha vati in the management of Klaibya (Erectile dysfunction)
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Improvement in penile erection, rigidty, sexual desire
研究概览
简要总结
SUMMARY-
Sexual health and functions are important determinants of quality of life. Sexual problems affect physical and psychosocial health and may have a significant impact on the quality of life. Erectile dysfunction(ED) is a type of sexual disorder characterized by the inability to develop or maintain an erection of penis during sexual act. Cardio vascular diseases, diabetes, depression, alcohol, smoking, neurological disease and trauma are the risk factors for the ED and it is increasingly prevalent with age. Approximately 40% of men are affected at age 40 and nearly 70% at age of 70. ED is known as kalibya which is a shukrapradoshaja vikara caused due to atyadika amla lavana kshara viruddha ahara sevana, veeryakshaya, bhaya, shoka, avishwas, streedoshadarshana, and due abhigata. Both sharirika and manasika bhavas are involved in the klaibya. Although lifestyle modification and psychotherapy are considered as first line of treatment in the ED, men presenting with ED expects the physician to help them with the measures and medication that can have improved result. So in this study Akarakarabha (Anacyclus pyrethrum) vati is selected, which is having katu rasa, ruksha teekshna guna, ushna veerya and katu vipaka and possesses vrusya balavardaka properties. Because of the ushna and uttejaka quality, it acts on the prajanana smastana as vajikararana and shukrasthambana. This study aims at evaluating the effectiveness of Akarakarabha vati in the management of klaibya. Data will be collected using case report from designed by incorporating all aspects for the study. Such collected data will be tabulated and analyzed using SPSS (Statistical Package for Social Sciences) version 20 and using appropriate statistical test.
OBJECTIVES
To evaluate the efficacy of Akarakarabha vati in the management of klaibya (erectile dysfunction)
METHODOLOGY: Interventional clinical study
RESEARCH DESIGN: Open labeled single arm prospective clinical trial
SAMPLING TECHNIQUE: Convenient sampling
SAMPLE SIZE: 20
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 25.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Male
入选标准
- •Minimum 3 months history of erectile dysfunction.
- •Age-25 to 60 years.
- •Fairly good glycemic condition (DMT2).
- •Those subjects ready to participate and follow the instruction and     sign the informed consent form.
排除标准
- •Subjects with,
- •K/C/O essential hypertension and cardiac, hepatic, renal disorders
- •Significant anatomical penile deformity
- •History of prostatectomy or penile implant.
结局指标
主要结局
Improvement in penile erection, rigidty, sexual desire
时间窗: 45 days
次要结局
- Increase in semen count(45 days)