跳至主要内容
临床试验/CTRI/2024/07/070748
CTRI/2024/07/070748尚未招募不适用

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

National institute of ayurveda1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年7月30日最近更新:

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

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Abhishek ranjan jha

National institute of ayurveda

研究点 (1)

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