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临床试验/CTRI/2024/05/066732
CTRI/2024/05/066732尚未招募3 期

Efficacy Of ASJ Granule Against Stambhanakara Yoga Granule In Premature Ejaculation - A Randomized Controlled Trial

Sojitra Sagar Rasikbhai1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2024年5月12日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
32
试验地点
1
主要终点
To Compare The Efficacy Of ASJ Granule Against Stambhanakara Yoga Granule In The Management Of Premature Ejaculation

研究概览

简要总结

For this study, 32 participants will be selected according to inclusion criteria. They will be randomly allocated to two groups namely the trial group and the control group with 16 participants each. the trial group participants will receive ASJ granule , 6 gm twice (morning and evening after food) daily for 60 days. The control group will be receiving stambhanakara yoga granule in same dose and duration . Assessment would be done on 0th day, 31st day, 61st day and 90th day of treatment using sexual dysfunction assessment questionnaire (Revised G Singh et al., 2001).

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
21.00 Year(s) 至 50.00 Year(s)(—)
性别
Male

入选标准

  • 1.Those diagnosed with premature ejaculation, as per DSM-V criteria.
  • 2.Participants aged between 21– 50 years, irrespective of race, caste, and religion.
  • 3.Those with regular and healthy partner.
  • 4.Those with a minimum score of 2 for performance anxiety, using the revised Singh.
  • 2001 questionnaire.
  • 5.Those willing to give written consent.

排除标准

  • 1.Diagnosed cases of diabetes mellitus, hypertension, coronary artery disease, thyroid dysfunction, renal dysfunction, and hepatic dysfunction 2.Those diagnosed with major psychiatric illness.
  • schizophrenia, BPAD, and major depressive disorder 3.Participants with known neurological or neurodegenerative cause for sexual dysfunction 4.Those who have other sexual dysfunction 5.Those on psychiatric drugs, anti-histamines, anti-parkinsonian drugs, and anti-epileptics 6.Those with any known substance abuse.

结局指标

主要结局

To Compare The Efficacy Of ASJ Granule Against Stambhanakara Yoga Granule In The Management Of Premature Ejaculation

时间窗: Assessment will be done on 0th, 31st, 61st, 90th day of study using Sexual dysfunction assessment questionnaire (Revised G Singh et al., 2001)

次要结局

  • To compare the performance anxiety, sexual satisfaction, quality of life(of subjects with premature ejaculation by Golombock Rust Inventory for Sexual Satisfaction ,Sexual Quality of Life Assessment Scale For Male ,Stress questionnaire by International Stress Management Association.)

研究者

发起方
Sojitra Sagar Rasikbhai
申办方类型
Other [Sojitra Sagar Rasikbhai]
责任方
Principal Investigator
主要研究者

SOJITRA SAGAR RASIKBHAI

VPSV Ayurveda college, Kottakal

研究点 (1)

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