An open label clinical trial to evaluate the efficacy of Vidangaadya Taila Uttar Basti and Pramehamihir Taila Upastha Basti followed by Amritprasha Ghrita in the management of Klaibya with special reference to Erectile Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- a. No erection at all
研究概览
简要总结
INTRODUCTION
Inability to obtain or maintain an adequate erection for satisfying sexual activity is known as erectile dysfunction (ED). The achievement of a proper erection with enough stiffness for penetrative intercourse is the most crucial of the many phases off sexual response ;failure and unhappiness result from the absence of this phase. In classical ayurvedic texts, this condition is carefully described as Klaibya. Importantly, ED has a significant negative impact on a man’s quality of life, including loss of self-esteem, avoidance of intimacy, anxiety and depression, which in turn exacerbate sexual dysfunction. This also impacts the relationship between sexual partners, including negatively affecting sexual desire and satisfaction of partners. Furthermore, ED is considered an independent risk factor for the development of metabolic syndrome, cardiovascular disease and type 2 diabetes mellitus, sharing common underlying mediators, and therefore ED is considered an increased mortality risk. Its incidence increases drastically from about 6% in the age group 20-29 years, to 50-70% in the age group 40-79 years Its incidence has been projected to increase significantly to over 320 million by the year 2025. India has been dubbed as the impotence capital of the world due to the high incidence of the life style diseases and probably the largest population of males in the world. It has been selected for the present study to find out a better cure for a happy and healthy sexual life. After considering these facts present work is formulated to assess the efficacy of Vidangaadya Tail Uttar Basti and Pramehamihir Taila Upasth Basti followed by Amritprash Ghrita in the management of Klaibya w.s.r. erectile dysfunction.
RESEARCH QUESTION Is there any efficacy of Vidangaadya tail Uttar basti and Pramahamihir tail Upasth basti followed by Amritprash Ghrit in the management of Klaibya with special reference to erectile dysfunction?
HYPOTHESIS
Ho There is no efficacy of Vidangaadya Tail Uttar Basti and Pramahamihir Tail Upasth Basti followed by Amritprasha Ghrit in the management of Klaibya with special reference to erectile dysfunction.
HAThere is effect of Vidangaadya Tail Uttar Basti and Pramahamihir Tail Upasth Basti followed by Amritprasha Ghrit in the management of Klaibya with special reference to erectile dysfunction.
AIM OF THE STUDY
To evaluate the efficacy of Vidangaadya Tail Uttar Basti and Pramehamihir tail Upasth Basti in the followed by Amritprash Ghrit in management of Klaibya with special reference to erectile dysfunction.
OBJECTIVE OF THE STUDY
To evaluate the clinical efficacy of Vidangaadya Tail Uttar Basti and Pramehamihir Tail Upasth Basti in Klaibya with special reference to erectile dysfunction.
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
- 18.00 Year(s) 至 60.00 Year(s)(—)
入选标准
- •1 Age : 18 to 60 years 2 Gender : Male 3 Patients presenting with Samanya Lakshana of Klaibya (Erectile Dysfunction) 4 Unable to consummate the sexual act due to lack of erection, lack of rigidity at least 50% of coital instances.
- •5 Patients willing to participate in the study.
排除标准
- •1 Spinal cord injury.
- •2 Major organic or psychosomatic disorder.
- •3 Poorly controlled Diabetes mellitus, Severe Systemic diseases, Uncontrolled hypertension.
- •4 ED due to surgery of colon, prostate, bladder or rectum.
- •5 Carcinoma of penis.
- •6 Hypospadias.
- •7 Phimosis.
- •8 Patients with possible effects of any medication.
- •9 Patients with Venereal disease, HIV.
- •10 Congenital chordee 11 Congenital defect of genital organ.
结局指标
主要结局
a. No erection at all
时间窗: at baseline, after 2 weeks of treatment
b. Erection but not sustained
时间窗: at baseline, after 2 weeks of treatment
1.Changes in score of Patient Questionnaire from
时间窗: at baseline, after 2 weeks of treatment
International Index of Erectile Function (IIEF)
时间窗: at baseline, after 2 weeks of treatment
2.Clinical Interpretation of Mlanashishnata-
时间窗: at baseline, after 2 weeks of treatment
c. Sustained erection
时间窗: at baseline, after 2 weeks of treatment
d. Erection but not enough for penetration
时间窗: at baseline, after 2 weeks of treatment
e. Erection enough for penetration Successful
时间窗: at baseline, after 2 weeks of treatment
intercourse
时间窗: at baseline, after 2 weeks of treatment
次要结局
- The secondary outcome of the study will be(assessed by changes of DSM V criteria score.)
研究者
Dr Abhishek ranjan jha
National institute of ayurveda
